from Concept to Cure.®
by Dr. Bill Gluck, Vice-President, Clinical Knowledge
In 2000 a movie entitled ‘Pay it Forward’ was released and it started a social revolution of sorts. Not only has the concept of doing a good deed and asking for nothing in return been popular, it has been a phenomena that has continued for many years. Within our industry, the ‘Pay it Forward’ concept has taken hold.
Companies within the pharmaceutical, biotechnology, and medical device industries, along with service providers, have embraced the ‘Pay it Forward’ ideal. I recently read an article about large companies like Pfizer and AstraZeneca and CROs like Quintiles and Parexel and other companies working with a non-profit organization, the Alliance for Clinical Research Excellence and Safety (ACRES) to share technology and services free-of-charge with clinical research sites. The focus of all this cooperation is to streamline and further research to benefit us all.
The ACRES initiative places networking technology at clinical research sites and other key study participants such as IRB’s, so all participants can access and share trial information quickly across the network. Through these efforts, Sponsors, sites, IRBs, CROs and regulators can share data, and in real-time, assess feasibility of sites to find patients for clinical trials. They can also assess the availability of well-qualified doctors to act as clinical investigators, thereby streamlining the trial initiation process.
ACRES has also been able to address another need within the industry – the provision of a centralized repository for documents required by FDA and other worldwide regulators regarding investigator qualification documentation¹. Rather than collect these data for each trial conducted from the same investigators, ACRES members will be able to access this data from one place. Member companies in ACRES donate the software and technology needed to make this idea a reality. The efficiencies to be gained using these collaborative efforts are far-reaching. For example, if Investigators need to make an update to any of their documentation, they only need to update the information in one place rather than the various repositories or databases maintained by the various companies they work with. Companies too will be able to maintain closer control and the most up-to-date information on the investigators. How far this level of collaboration can go is yet to be seen.
Other collaborations have also taken hold such as the sharing of clinical data from trials that have not met specific milestones, and by sharing this data; there is the potential that other uses or therapeutic indications might be discovered.
The ‘Pay it Forward’ concept is not new within our industry. In fact, innovative companies who are focused on delivering meaningful treatment to those in need as quickly and as safely as possible have given their innovative technology, free of charge, to support the development, from the initial concept to the actual cure.
By Dr. Bill Gluck, Vice-President, Clinical Knowledge
Recently, the European Forum for GCP (EFGCP) and MedTech Europe established a Medical Technology Working Party to promote the collaboration of defining and establishing standards within the medical device sector of the much larger clinical development industry. As noted by Dr. Klingmann, the Chair of EFGCP, the focus within the industry has been to create a more standard environment for the pharmaceutical and biotechnology sectors. The collaboration and discussion to be held by the working party will be critical as it is nearly impossible to simply over-lay the current pharmaceutical standard and apply them to the medical device/technology world.
The establishment of the Medical Technology Working Groups provides an avenue to review the benefits of standardization within our industry as a whole. Standards must be global in reach and based on both good clinical practice and manufacturing guidelines, especially in the case of medical devices and technology. The work defined by the group will likely consider standards, based upon expert opinion and fit for purpose; consensus, based upon best practices; and guidelines and regulations. They should also demonstrate independence. Done correctly, standards should encourage innovation and have distinct links to the healthcare world.
Standardization can be implemented through eClinical solutions, which CDISC has done a good job of addressing. As the industry experiences success with eClinical solutions, new pain points are being addressed, with each solution offering its interpretation of efficiency. The best solutions are flexible and can accommodate both the needs of the trial and the standardization to maximize efficiency, without requiring additional complexity of data integration.
While there are clearly no right or wrong standards, their implementation can save significant time and cost especially when considered as part of a study and not applied retrospectively. There needs to be an a priori culture to develop and implement standards in the early stages of trials. The application of standards does not ensure quality; in fact retrospective application of standards has the potential to adversely affect data quality and analysis.
Unfortunately information is also sometimes lost if data are collected using different methods and later mapped into a common standard – trying to force a square peg into a round-hole syndrome. Standardization done correctly and involving experts like that of the initial organization of the combined working group of the EUGCR and MedTech Europe has a great chance to succeed and is positioned to help enhance future device and medical technology innovation through the use of standards, which can only benefit us all…the first steps have been taken and we will all be better served in helping this important working group achieve its objectives.
By Laurence P. Birch, Chairman and CEO, DATATRAK
I read a discussion on LinkedIn recently where someone asked for feedback on eClinical solutions to the community of members. The initial question focused on market share in the industry, by company.
There is no doubt that when it comes to market share, the perception is Bigger is Better. Makes sense, on some level, that the solution that sells the most has to be the best.
But that simply isn’t true.
Sure, if you select either of the most purchased platforms in the eClinical industry, namely Oracle InForm or Medidata Rave, you won’t get fired. But if you have the foresight to break out of that rut and actually consider the benefits of other solutions, and yes, namely, DATATRAK ONE®, you may actually get promoted.
The reality is in most industries – I would suggest nearly all – technology-driven solutions are transforming productivity and improving efficiency. Industries from manufacturing to music are not only open to but clamoring for new technology to resolve both old and new pain points. And the companies that are doing that are winning, and shaking up the old standbys. The end result? More efficient and effective processes from all suppliers in the industry and a better outcome for their users.
Looking at the eClinical industry, new solutions are making real differences to reduce the time and cost required to bring meaningful treatments to those in need. But our industry is slow to change—why? I think because companies are so weary of the complications and difficulty of using the current systems, that they are afraid that change will be risky and hard to manage—and the big players promote that change will be very, very difficult. Think about that folks; marketing through fear is not a good business model. IBM did that for years until customers realized that it simply wasn’t true. The perception that change is difficult and expensive in the eClinical space is equally misplaced. The reality is just the opposite, at least with DATATRAK.
I won’t go in to how we do it here, but our approach to Clinical Trial Data Collection and Management IS better: we DO remove complexities. Our solutions are SIMPLE to use – and that means faster, easier training too!
The core of our ease-of-use and training is our Unified Platform. There are no required data moves, no integration between solutions, with all data visible on every solution, all the time. For example, when trial changes occur, and they do, the UNIFIED nature of our platform allows for faster, less expensive validation. These features deliver real benefits –driving cost and complexity OUT of the trial – and improving patient safety. If our goal as an industry is to allow people to live longer and better lives through successful drug development, shouldn’t that start with the safety of the patient in the drug trials? We at DATATRAK think so—and we know you do too.
We are making headway changing the perception of the industry. Those who have had the foresight to look beyond the top 2 providers and move to DATATRAK have had great results, and more of our clients are moving from trial-by-trial to enterprise agreements. Fully 100% of our clients use 2 or more DATATRAK solutions, and 67% use 3 or more. They are experiencing the benefits of the Unified Platform – something the top 2 can’t offer.
DATATRAK ONE® UX is a GLOBAL platform and being used around the world; we are a leading eClinical solutions and services provider with growing business in all trial phases with all types of clinical trials. We have embraced CDISC standards and our executive team has over 100+ years of life sciences experiences, with a deep understanding of clinical research that we have leveraged to build a truly superior solution to address the needs of clinical trials.
So come on over. Sit in on a demo. We guarantee you will see the rewards are great if you look past the top 2.
Because Bigger Isn’t Always Better. DATATRAK is better.
This blog contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as well as historical information. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual, results, performance or achievements, or industry results, to be materially different from anticipated results, performance or achievements expressed or implied by such forward-looking statements. When used in this blog, statements that are not statements of current or historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “plan,” “intend,” “may,” “will,” “expect,” “believe,” “could,” “anticipate,” “estimate,” or “continue” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements, although some forward-looking statements are expressed differently. For a list of certain factors that may cause actual results to differ from those contemplated in forward-looking statements, please see the Company’s periodic reports filed with the OTCQX Market. The Company undertakes no obligation to update publicly or revise any forward-looking statement whether as a result of new information, future events or otherwise.
from our CEO, Larry Birch
Industry after industry, there are many examples of how hyper-connected consumers and social media are changing businesses and forcing entire ecosystems to adapt to the new paradigm. The drug and device development industry is set for dramatic change to realize time and cost savings. Those that are able will lead in productivity, reducing the cost to deliver meaningful treatment to the world.
Every company must be studying how Mobile, Social, Cloud and Big Data will revolutionize – or marginalize – their business. The explosive growth in these areas will have a dramatic impact on drug and device development, and time will tell if regulatory agencies, CROs and Pharma can respond quickly enough.
Wearable Technology is defining the next wave of mobile health. For the clinical trials industry, the rapid growth of low-cost wearable health monitors for the consumer market is a fantastic avenue for identifying potential patients and gathering huge volumes of data spanning years of an individual’s life. The game changer is the ease of data collection – just snap on a wristband or tag onto your clothing and you are collecting data.
Self-measurement and tracking of personal habits will surely provide clinical researchers much needed data about the health history of patients. However, the next frontier for pharma companies and clinical research organizations is to tame the vast landscape of social media. As more patients turn to the online communities for support and information about clinical trials available in their area, companies need to find a way to respond within the scope of the current rules and regulations.
The best Cloud-based solutions in the market today are scalable, secure, fast and configurable – that’s right configurable. In the clinical trials industry, enterprises need to carefully evaluate vendors to determine if every installation is a customized deployment or if it is truly a cloud-based solution that will enable your business to scale.
For patients in a clinical trial, the potential to capture nearly unlimited data about their mood or daily food intake during the study by having the user snap a quick picture of each meal changes the landscape of data analysis for clinical trials – pushing the envelope of Big Data significantly over the next several years.
In the clinical research industry, a consortium of pharmaceutical companies has formed a not-for-profit effort, Project Data Sphere, to share and analyze de-identified, patient-level data from late-stage comparative studies to be analyzed. The hope is that with access to historical clinical trial data more efficient clinical trials can be designed, reducing the cost and accelerating the speed of finding meaningful treatment. Leveraging this dormant data is one example of how the clinical research industry can use the powerful techniques used in Big Data analytics to actively address the safe acceleration of clinical trials.
The ability of the industry to adopt these advancements, and others we aren’t even imagining, is the real question. Certainly a deeper understanding of the benefits, and pitfalls, of these technologies must be well understood and delivered not by technology experts alone, but by industry leaders who have a deep understanding of the needs of clinical trials and the technology. Without expertise in both areas, the true potential of technology to transform the clinical trials industry will be only partially realized.
The team that developed the DATATRAK ONE® Unified Experience™ shares their favorite features of the eClinical solutions.
Software Developer, Sean Thrailkill
I helped develop the Unified Experience™ for the Manager tools we use to handle clinical data in the DATATRAK ONE®platform. I am most excited about how useful the new functionality is. By simply configuring a few properties for a trial, it is easy to define a study’s workflow.
In the previous version of DATATRAK ONE®, if a user wanted to see all the forms that had been SDV’d and were ready to freeze, they would have needed to first select a patient, and then search for all forms that had been verified for that patient. This would give them a list of SDV’d forms for a single patient they could then Freeze. The upgrades to DATATRAK ONE® allow the user to analyze how much work needs to be done simply by looking at any patient or form. Each entry in our Managers, be it a patient or form, is assessed along a variety of metrics like completion, SDV, queries issued and closed, etc. Progress with regard to these metrics is measured with informative color-coded progress bars. When hovering over a progress bar in a Manager (Patient Manager, Form Manager, Question Manager), a tool tip appears displaying exactly the number of data points in each status that determines the progress of that metric (ex. SDV’d, Needs SDV and Not Ready for SDV). Users can “drill down” on the patient simply by clicking on what they wish to view. Continuing with my example from above, if I wished to view all forms that need to be Frozen for a patient, all I would have to do is click the red segment of the Frozen Status column, and I would instantly see that set of forms!
This upgrade enables users to immediately, and easily, drill down to the specific data requiring action. I hope that this will allow users to spend less time determining what data they need to be reviewing and more time cleaning the data, which lowers the overall time and cost required in the clinical trial, reducing complexity and safely accelerating the trial.
Sr. Clinical Data Manager, Todd Thompson
The most exciting upgrade to the DATATRAK ONE® platform is the improvements to the Manager Interface and the advanced Filters within the Managers, adding an unprecedented level of responsiveness and efficiency. The upgrades enable insight to the current status of data, requiring less time to find the data, and more time to review it.
The ability to easily organize and analyze data through filters, progress bars and my personal favorite – drag & drop functionality – lets each user customize the view of the information.
Let’s be honest, most Data Managers have worked with many different systems. Some can be rather user friendly while others can make you want to pull your hair out and scream! With the improved DATATRAK ONE® platform, I am able to customize the Managers to meet MY NEEDS.
Each Manager is made up of columns and rows that pertain to statuses. Within these columns, we now have a color-coded progress bar. Each progress bar is color coded to indicate where you are in the process of data entry and cleaning; if you hover your mouse over the progress bar it will provide you with a percentage of completion. The colored portions of the progression bars can also be clicked to drill down to a more specific Manager. The Subject Manager links will redirect to the Form Manager. The Form Manager links will redirect to the Question Manager. These links cut down my time filtering for data and make me more efficient in my daily tasks.
Filters can be used to store any of the components of the Managers that you do not wish to view, and it allows you to save your search and filter settings for future use. With many other systems, I am bombarded with statuses and other information that I do not need during my daily study maintenance. I normally would have to scan through and disregard the given information that I do not need. Now, I can easily customize these tables to only provide what I need.
Here is where my favorite upgrade comes in – the Drag & Drop Functionality. Not only can I make customizations to meet my needs, DATATRAK has made the customization process incredibly user friendly. With the Drag & Drop Functionality, the columns can be arranged and rearranged within the Manager table and the unused columns moved to the Search table where they can still be used as Filters. The column will retain any filter and sort settings while freeing up space in the table itself. All the user has to do is hover the mouse over the column name until the cursor changes to a 4-way arrow. Then you just click and drag the column to another portion of the Manager table or to the Search table (see Below).
Improvements to the UX EDC & Medical Coding™ and UX Randomization & Trial Supply Management™ Managers have transformed data management to help you use the data to manage the trial, rather than managing the data itself.
By Niki Kutac, Director, Product Management
Over the past decade we have drawn attention to the issues inherent in the frequent practice of merging or integrating eClinical products. However, because major competing vendors almost uniformly utilize an acquisition strategy to expand their product offerings, clients are led to believe that the resulting costs and complications are unavoidable. It is often difficult to change the public perception of inefficiency from a cost to be absorbed, to a problem to be fixed. DATATRAK discovered and addressed it almost ten years ago.
Giving a Name to the Solution
We have spoken often on the glaring inefficiencies that product integration has brought into the clinical trials space, and how DATATRAK through proper planning has avoided them. The DATATRAK ONE® Unified Platform removes complexities in clinical trials, so all solutions work seamlessly together. That’s what we refer to as the Unified Platform.The innovative nature of DATATRAK ONE® is precisely why we differentiate our products by describing them as Unified rather than integrated.
Unfortunately the meaning ‘unified’ is often muddied in our industry. Our competitors have generally engaged in the practice of acquiring and integrating new products in an effort to create a full offering of eClinical software. When we say unified, we mean something very specific.
We built, rather than bought, our products. Our system operates off a single database, providing a true Single Source of Truth. We feel that our superior architecture gives us the freedom and agility to improve our software to reflect the needs of our clients; DATATRAK solutions are not bound by the rigid infrastructure endemic to many of our competitors’ solutions inhibited by years of legacy integrations.
Creating the Best Possible Solution
DATATRAK, provider of the first cloud-based solution on the market, had a fully unified EDC and IRT system up and running in 2005. The fact is that from our early beginnings, our products have been built by the industry’s preeminent thought leaders. We did not merely respond to the needs of the market, we anticipated them.
The Unified Future – Today
DATATRAK has developed a truly Unified Platform.
There are many benefits to our Unified Platform. In particular, I draw attention to two items. The first is Lower Total Cost of Ownership. The simple fact that we are a unified eClinical® solution is why our cost of ownership is typically lower than integrated systems. A superior product should save you money. Competitors with an Integrated (and not a unified) product customarily transfer the costs of inefficiency to their customers either directly in terms of price, or indirectly by way of unplanned expenses.
The second is the cost of change, and how it is directly related to the requirement of increased study agility. Clinical trials are conducted in a tumultuous environment, and unplanned challenges can often be the most costly. A proper eClinical suite should allow a client to respond to change quickly and at minimal cost. Having a unified system is what allows DATATRAK to outperform in this capacity. In integrated systems, migration is generally a requirement because disparate systems traditionally use separate database sources. The DATATRAK unified eClinical® system has only one database, so there is no need to perform data migration. Your study is available to work in during a mid-study change, including access to and working in and with casebooks. So your study can implement changes as required while the work of the trial continues. These are some of the benefits of our unified platform available today: DATATRAK ONE®.
Transforming the Clinical Trials of Today, Planning for the Trials of Tomorrow
The latent benefits in DATATRAK ONE® save both time and money, and these savings are passed on to our customers across the lifecycle of their trials. By having a platform unburdened by legacy integrations, we are left with the freedom to respond to the demands of a rapidly changing clinical landscape. Our system was built by forward-thinking minds. By anticipating the need for a unified platform, we have been able to deftly avoid this arena of complications. While competitors have struggled to piece together Single Sign-on, we will continue to provide innovative, intuitive utilities with unparalleled user configurability. With the exploding costs of clinical research, the industry must look to technology as a source to increase productivity. DATATRAK combined the experience of our Executive Management Team, with over 100+ combined years of Life Sciences experience and a deep understanding of clinical trials, with technology visionaries. Theircombined expertise resulted in a system that addresses the needs of clinical trials.
Unification is, for us, not a feature, but a design philosophy. Our efficiencies of design and levels of reliability cannot be replicated by key competitors today because the choice to build a unified system must be made on Day 1. There was a time not so long ago when the decision-makers in the pharmaceutical industry had to make the hard call to revolutionize the way that we conduct clinical trials. No one will deny that introducing advanced IT to the industry has had profound effects, but this process does not stop at the point solutions of EDC, IRT or CTMS. They are confronted with the new reality that a single end-to-end system, a unified platform, is needed to keep this giant engine running at full steam.
Choices of technology in the coming years will effectively define the efficiency of the industry at large. The choice before you, the decision makers, is this: “In whom do you place your trust, the market-leaders who appear to only now address the issue manufactured by their own short-sighted business moves, or the vendor that anticipated these needs, from the beginning of the EDC market?” You can buy in to the promises of a unified future tomorrow, or you could instead realize the benefits of the future, with the DATATRAK ONE® Unified Experience™ today.
by Dr. Bill Gluck, DATATRAK Vice President Clinical Knowledge
Technology has transformed industries from music to exercise and beyond. From wearable technology to live traffic flow on your smartphone, the expanding capabilities that are transforming our daily lives are also transforming the clinical trial industry, albeit a bit slower.
Today, 70% of clinical trials use eClinical solutions. For those trials that use some aspects and are considering more, or for those who are considering it for the first time, knowing what benefits to look for is imperative.
Advances in technology have opened the door to a new clinical environment, the eClinical environment. The term ‘eClinical’ describes the application of a specific technology in a trial, or to a general group of applications that fulfill many functions across the trial. Consider EDC, ePRO, Randomization, Imaging solutions and other technology options to address clinical trial data. Each can be used individually or in any combination, but in any instance, is referred to as the eClinical environment.
Understanding and choosing the best set of technology tools is critical to the overall success of the application. Today, there are many options: individual applications used as a standalone solution, various applications that are bundled or integrated, or a robust set of applications developed to work together that use a single data source.
In order to reduce the risk involved in employing technology tools, a good first step is to understand your needs from a functional level.
Defining the Need
Defining the specific need you are hoping to address is the first step. Your relevant set of options will be directly driven by the focus area; data management, randomization, inventory control, among others, are areas where eClinical solutions are readily available.
Ensuring the application conforms to all current regulations and guidelines is a prerequisite. Data security, accessibility, data storage, system reliability and ease of use are important to assess when choosing among qualified options. Determining the extent to which the trial will utilize technology is critical when selecting solutions. Choosing a comprehensive suite of solutions greatly differs from the selection of one or two products and can dramatically affect time and cost of training.
When selecting the vendor, a robust education program is crucial to ease training the user community. Ensuring all members of the trial team are properly trained will help leverage the power of the technology to drive real time and cost savings. Ensuring the tool is accepted in the company culture and environment is imperative to operate as effectively and efficiently as possible. Training is a requirement to gain the optimal benefit from the use of the application both in terms of financial value and a streamlined process workflow.
Several types of training are typically offered by leaders in the eClinical industry. Online, on demand training, available through a recorded video is a great benefit for users who can simply select the topic and learn from watching the video in the moment they have the question. Live training is optimal for the initial training session and more interactive sessions for more advanced users. A hybrid method, a webinar, is an online session hosted via web, where attendees can submit questions and they can be answered during that session without anyone leaving their desk.
The availability of a robust training portfolio is a critical decision point when choosing an eClinical provider.
No matter how much training has been given, questions always come up. Each trial is different and has various needs; Ensuring the vendor has the resources to meet your needs is important. While the questions do not deal directly with reducing the risk of the scientific structure or nature of a clinical trial, it does pertain to the operational efficiency and quality of results a clinical trial will produce.
When assessing the Help Desk Support, more isn’t always better. Many companies offer vast numbers of support around the globe because the help is needed. The more complex the product to use, the more support is likely needed. Don’t get caught up in the numbers game when it comes to support. Rather than asking how large the staff is at their respective help desks, ask how many calls they receive per day per client, on average.
For the best possible outcome, start with the end in mind when considering eClinical solutions. Technology can drive real time and cost savings by reducing complexities in managing clinical trial data, but to realize the fullest potential, the right solution and partner is key. A single data source, no downtime, easy-to-use, and intuitive training will drive greater efficiency for the trial.
In the next blog we will discuss how we can leverage technology to assist clinical data managers, clinical operations, and safety in data review and reporting, thereby increasing data quality and reducing risk.
by Dr. Bill Gluck, Vice-President Clinical Knowledge
The recruitment, or enrollment, of patients for clinical trials is a key factor driving the success or failure of any study. The ability to enroll the correct number of qualified patient/subject populations allows sponsors to optimize logistical issues, including time to identify potential sites, qualify the sites and staff, and collect the essential documents from each site prior to the initiation of any study.
In recruitment, there are several areas of potential risk: site selection, training of site staff and personnel, and the capability of the sites to leverage eClinical solutions to conduct the study within the guidelines of good clinical practices. Technology is actively simplifying these processes and reducing the related risk.
Many sponsors will conduct feasibility studies to determine the ideal locations where specific patient populations exist in order to optimize their ability to quickly enroll a particular study or trial. Often sites that have promised several qualified patients fail to enroll a single person thus making the time and effort spent in assembling the essential documents per GCP into the trial master file (TMF) non-productive. In order to mitigate this risk, careful screening of potential sites is needed. Knowing the specific parameters defined in the study protocol is very important; the site environment must be conducive to finding and supporting the specific patient population being studied. In many cases, this is accomplished through the evaluation of past site performance and the reputation of the principal investigator.
Site Staff Training
Finding experienced clinical trials professionals is becoming an increasingly difficult task. As many new doctors are entering the clinical trial arena and assuming principal investigator roles, training is a necessity. Technology is facilitating the transfer of this knowledge, through a wide variety of sources. The use of social media and webinars has contributed greatly to the spread of education throughout the industry. Vendors provide a wide variety of learning opportunities, from basic data management to risk-based monitoring, and industry trade shows feature clinical trials leaders who willingly share their insight and expertise.
Blogs, white papers, and case studies are also widely available, addressing the most basic topics to the most advanced challenges, giving each professional the opportunity to target their learning.
Good Clinical Practices & Technology
The use of technology, from electronic trial master files to clinical trial management systems (CTMS), can assist principal investigators and their staff in conforming to the complex and growing regulatory environment. Fundamentally, investigators need to be educated on the role of eClinical solutions in clinical trials as they complete medical school. A number of the top tier eClinical vendors, including DATATRAK, are providing their software to educational institutions to be used in clinical research curriculums by students to prepare them for the industry. Gaining a sound understanding of regulations and hands-on knowledge of the available technology can deliver immeasurable benefits to the trial.
The growing use of electronic health records will supplement and help reduce risk of poor enrollment rates by providing more insight to where targeted patient populations exist, making recruitment efforts more refined. The quality performance indicators of sites and specific principal investigators can be tracked in an easier fashion as these records become more readily available and integrated with current clinical trial management applications.
Study enrollment and site qualification risks can be mitigated through the use of electronic health records and current EDC and eClinical solutions applications. Medical records and the ability of sites to adequately maintain these records per FDA or ICH guidelines likewise is enhanced and related risk mitigated. Educational programs that take advantage of all of the tools available in the industry today as they teach the next generation of doctors, nurses, data managers, and site coordinators, will do much to provide pools of qualified and experienced clinical researchers in the years to come.
by Dr. Bill Gluck, Vice-President Clinical Knowledge
In the development of any drug, biologic, or medical device, it is necessary for some level of testing to be conducted. A series of clinical studies or trials are needed to test and validate the safety and efficacy of the intervention, while ensuring patient safety. In order to conduct these studies, human volunteers both healthy and those having the specific disease or condition being studied are needed to participate. Ensuring there are safeguards to to ensure patient safety is of vital importance.
Historically there have been studies conducted where ethical standards have been questioned or compromised, and the safety of each study participant has not been placed at the forefront. In order to prevent this from happening, measures have been put into place to protect participants in research, and specifically for our focus, clinical studies. The FDA provides a general reference with more detailed information on the laws, rules, and guidelines in place to ensure study participant safety. The focus in this blog is on confidentiality, participant safety and understanding as part of the informed consent process, and self-audit benefits.
During the past 30 years, the implementation of a variety of technology tools has quickly advanced the availability and accessibility of information, more than ever before. As a result, there is a need to provide safeguards to ensure the confidentiality of all study participant personal data which is gathered during the course of a clinical study. These measures have been defined as part of the U.S. federal law that protects personal medical information: the Health Insurance Portability and Accountability Act (HIPAA).
Guidelines, regulations, and privacy laws have been enacted internationally to protect the privacy and confidentiality of all study participants. The US Department of Health and Human Services, Office for Human Research Protections offers a compilation of Human Research Standards enumerating over 1000 laws, regulations and guidelines from over 104 countries and a number of international and regional professional organizations.
The implementation of these laws support data privacy and are actively monitored, supporting the privacy of trial participants.
In any clinical research endeavor involving human participants, any potential study subject (healthy volunteer) or patient (study participant having the disease or condition being studied) needs some way to assess whether or not the study is safe. They need to know about the study, how it is to be conducted, and how their safety is to be assured. This information is communicated via the informed consent process. Informed consent is the process by which details of each clinical study is communicated with participants. For purposes of this entry, please note that the informed consent process has a much wider scope than clinical studies in how it affects patients.
The real risk of the consent process is two-fold: first, patients may not truly understand the risk they could potentially face, and second, patients may be incorrectly recruited for participation; they may not meet the criteria for inclusion into the study.
To mitigate these risks, training is essential. Each investigator and their respective staff members must be trained and fully understand and know the consent process and the site’s specific processes and procedures. Training sessions also must be held on a regular basis, typically annually, to ensure processes and procedures are understood by any new staff members and that any updates to current law, regulations, and/or guidelines have been made and are reflected in updated processes and procedures. By performing annual training sessions as part of a standard procedure, it helps to ensure each site’s consent process is in compliance with regulatory laws, regulations, and/or guidelines.
On a more study-specific level, each study protocol needs to be reviewed in concert with the consent process to ensure each aspect of the study protocol is clearly explained and understood by each study participant. To support compliance and further mitigate risk, there needs to be a series of checks to confirm that the consent process has been completed in compliance with all appropriate laws, regulations, and/or guidelines. To help further reduce risk, a process by which the site can monitor the consent process should be implemented.
Once the study participant has an understanding of the study via the informed consent process, he/she also needs to understand that there is the potential for data gathered on them to be transferred from one group to another within the study. For example, data may be sent from laboratory samples taken at the site to a reference lab. Procedures like this should also be explained as part of the consent process. Each subject or patient should be confident that their personal information is protected.
In order to ensure the proper measures are in place to minimize risk, especially to ensure the protection and confidentiality of patient data, the identity of each study participant should be ‘masked’ – meaning names, hospital identification numbers or other means or links that would identify a study participant should not be used. Typically study participants are assigned study numbers that are only accessible in the event of a safety concern.
To mitigate risk, consistent reviews of standard processes and procedures describing how participant data and confidentiality is maintained should be conducted. As part of the review, there should be a process in place to ensure there are no patient identifiers present on any study documentation. All staff must be trained, with clear documentation of results so each staff member knows and understands the standard processes and procedures of their respective institution/site and of the applicable laws and regulations for their locations.
One way to ensure understanding and compliance is to incorporate a self-audit as part of the standard procedures and workflow. Through the audit process, the standard processes and procedures as well as staff understanding and compliance to the standards, can be tested and documented. Should remedial training be required, it can be identified and immediately addressed through the audit process.
The next blog in this series will explore ways for sponsoring companies or CROs to deal with reducing the risk of site selection and staff qualifications. Components of the process for defining quality measures applicable to determining risk-based monitoring thresholds will also be discussed.
by Dr. Bill Gluck, DATATRAK Vice President Clinical Knowledge
The cornerstone of any clinical trial is the study protocol. As the protocol is the overarching blueprint for the trial, it is imperative to root out risk in this planning stage to optimize the entire trial process.
Protocol design impacts both patient and trial risk. Importantly, if the protocol is not designed appropriately, it fails to achieve its ends, resulting in wasted investment and more importantly, patients put through a trial for no purpose.
The study protocol aspects discussed below include:
The Study Objective
The protocol should clearly outline why the study is being conducted with distinctly defined primary and secondary endpoints. These endpoints are the specific data points that, when collected and analyzed, will answer the question of why the study is being conducted. The objective must also clearly describe the methods to be used during the conduct of the study to ensure the data to be collected is relevant and will address the study purpose.
Procedures or Assessments to Answer the Study Objectives
To identify risk areas in a study protocol, we must first question the purpose of the study and determine the data that should be collected in order to answer the question(s) being researched. Reviews by subject matter experts should be conducted to reduce the potential risk in the initial development of the study protocol, particularly in the area of question development.
Are the data being collected the right content during the course of the study? Is there a need to conduct a mid-study review to ensure the study protocol remains focused? If adjustments need to be made, is there a process or procedure defined as part of the company’s standard operating procedures to amend a study protocol to ensure the right data are collected at the right time? We will discuss adaptive study design as a risk mitigation strategy in greater detail in a later blog entry.
The Role of Non-Clinical Data
As discussed above, the study protocol defines which clinical data are essential to support the findings and conclusions of the study; however, there are also non-clinical data collected during the course of any clinical study. Again to reduce the risk, a review of the entire body of clinical and non-clinical data should be conducted by subject matter experts. In many cases either information learned from previous studies or prior research publications will substantiate the need to collect these data.
Site Selection and Patient Enrollment
The logistics of the study design, its complexity, number and location of the sites needed to enroll the target study population will impact the assessment of risk. The ability to find sufficient study participants often presents one area of risk that has a direct effect on the success or failure of a clinical study. By involving investigators, product experts, biostatisticians, data managers, and outsourcing partners (CROs), the risk associated with enrollment can be mitigated. Reviewing the feasibility of study inclusion or exclusion criteria and assessing the target population very early in the development process helps to reduce the need to implement plans to add sites or to reduce them, as well as to reduce the need to amend the protocol should enrollment restrictions prove to be too prohibitive or negatively impact the rate of enrollment.
Eligibility Criteria and Risk
A critical aspect of the study protocol is the definition of eligibility criteria. These criteria need to be defined as objectively as possible. The foundation of the success of any clinical study is to ensure only qualified subjects are allowed to participate. The patients need to be informed of the potential personal risks through their participation in the clinical study via the informed consent document, which will be discussed in greater detail in a later blog. The inclusion and exclusion criteria need to be founded on evidence found in prior studies or scientific literature. Reviews by experts can assist in reducing the risk of having either too lax or too restrictive eligibility criteria.
Planning for preemptive study protocol reviews to determine the effectiveness of the enrollment progress, and the reasons why some subjects (patients) fail to qualify for enrollment, should be held to ensure the correct qualification criteria have been defined and enforced. Using this strategy the study team should be able to make protocol amendments as needed to ensure the correct target population is being enrolled and that the criteria continue to support the potential study conclusions from both clinical and statistical perspectives.
Managing the trial
Even given the ability to attract a study population, can the sites implement and conduct the study as designed? Care must be taken to select sites having the background, knowledge and capacity to conduct the study as defined by the protocol. These factors will be explored in greater detail in a later blog in this series.
For more fundamental information on clinical trials please refer to the International Conference on Harmonization (ICH) guidelines for good clinical practices (www.ich.org) or the FDA Consolidated Guidance for Good Clinical Practice (E6) (www.fda.gov/downloads/Drigs/Guidances/ucm073122.pdf).
The next edition of this series will address study participant rights and safety as well as provide risk mitigation strategies to ensure measures are in place to address subject (patient) protection and confidentiality.
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