Contributed Commentary By Jill V. Platko, Ph.D., Suvoda  

June 23, 2023 | It’s no coincidence that clinical trials are becoming more complex. Advancements in technology are enabling sponsors, clinicians, and trial teams to gather more information than ever before. However, the latest “bells and whistles” can add complexity to trials and distract trial teams from their main focus: collecting data to advance therapies for very ill patients who need them most.  

After all, don’t we owe participants our best effort to set trials up for success? As Ken Getz, Deputy Director of the Tufts Center for the Study of Drug Development, illustrated in his book The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial, participants are, at times, risking their lives in hopes that these trials not only help them but even more so to answer questions that may improve health outcomes for others. The ultimate respect for this act of altruism is to honor participants’ time and sacrifice by keeping trials focused and efficient; thoughtfully utilizing technology to gather high-quality data to give the best possible chance for trial success. 

Growing protocol complexities: are they avoidable? 

Today’s clinical trial protocols continue to grow in complexity. Tufts Center for the Study of Drug Development (Tufts CSDD) uses protocol amendments as an indicator of trial complexity, and they have reported that 57% of protocols had at least one substantial amendment, nearly half of which were deemed “avoidable.” Such amendments increase costs and can delay trial completion. 

The question is: why are protocols becoming so complex? In my experience, complexity can arise when too many stakeholders have competing priorities. Multiple sponsor teams, eager to gather as much information as possible and enabled by eCOA (electronic clinical outcomes assessment) technology designed to collect data, can lead to excessive data collection and evaluation.  

Clinical trials related to migraines provide one telling example. The primary endpoint for a migraine trial is the number of migraine days. The definition of a migraine day is simple enough that a few questions in a daily diary—about pain intensity, duration, and presence of specific symptoms—can determine if that day qualifies. In some cases, I have seen well-meaning trial sponsors push for more complex electronic diaries to gather information on individual headaches to further research into migraines. These diaries are complex to build, test, train on, and even for trial participants to complete. Research to deepen our understanding of disease is critical to any field, but I would suggest it should be a part of basic research outside of the context of a clinical trial, so trials can focus on collecting information on potential therapies’ effects. 

Trial Gamification: Necessary Or Negligible? 

Another example of advancements in technology that can add to trial complexity is the gamification of eCOA systems. Clinical trial communities, always looking to improve and innovate trials, are increasingly exploring gamification elements to make eCOAs more user-friendly and engaging trial participants.  

However, I would argue gamification of data collection is not the best approach for most clinical trials, especially those that focus on life-threatening diseases. Collecting high-quality clinical outcomes data requires accuracy, integrity, and validity. Because games are subjective in nature and clinical trial populations vary in age and preferences, designing a gamified eCOA and getting everyone on board with it can be challenging.  

What’s more, gamification may not be necessary for participant engagement. For instance, compliance with eCOA, specifically e-diaries, already is high and the quality and quantity of data collected are usually sufficient. Hence, adding gamification to encourage e-diary use may have a negative impact on a study and its timeline if gamification increases complexity, introduces bias, or creates an unnecessary risk of data loss. 

I also worry that the hype around gamification somewhat fails to acknowledge the reality of many clinical trials and minimizes their seriousness. It’s important to remember that clinical trials involve real people, some of whom are fighting for their lives, and adding gamification may be seen to minimize the real participant experiences. 

That’s not to say that gamification doesn’t have a place in clinical trials. The Trial Innovation Network (TIN) is exploring the use of gamification to better engage the trial workforce and improve the efficiencies of trial activities. In this application, gamification may be an important innovation to advance trials. 

Simplifying Trials With Practical Ecoa Applications 

Trial participant recruitment and retention already is a concern in clinical trials, so collecting excess data or collecting data in a way that could jeopardize its validity can adversely impact trial outcomes. A well-designed eCOA asks only what is necessary and requires only as much engagement as is needed for the study to arrive at a definitive answer to the primary question being explored in the trial. 

A practical and focused approach to eCOA will aid in reducing complications that result from adding unnecessary elements that push participants to provide more data. Supportive solutions enable data collection in a way that is focused and reliable. Keeping protocols simple and targeted will reduce participant and site burden, simplify data analysis, and keep trials focused on the primary goal—to determine the safety and efficacy of tomorrow’s cures.  

Dr. Jill Platko is vice president of scientific services at Suvoda. In her 16 years in the industry, Jill led the Scientific Advisory practice at Signant Health and held eCOA-related positions at Covance and PHT Corporation. She earned her doctorate in Genetics and Development from Cornell University. She can be reached at jplatko@suvoda.com.