The future of clinical trial design
The costs of clinical trials have grown substantially in recent years, and as a result, clinical trials are now one of the most expensive elements of drug development.
Considering this, many companies are exploring how they can reduce the financial burden through effective trial design, improved efficiency, and changing the strategy for recruitment and retention.
Although clinical sites have the potential to partner with sponsors to improve all aspects of clinical trials, sites are often excluded from the conversation.
To find out more about reducing clinical trial costs, we spoke to Ravi Thadhani, MD, MPH, Vice Dean of Research and Education at Cedars-Sinai and Teri A. Grieb, Ph.D., Chief Scientific Officer, Senior Director for Research at the University of Michigan, about the coming changes in trial design.
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According to Ravi, the growing focus on reducing costs and improving enrolment for clinical trials has the potential to ease some bigger challenges in the sponsor-investigator relationship.
The first step in reducing costs involves “leaning on technology and existing data to more efficiently identify potential participants based purely on their health data”. The traditional methods of identifying, screening, and determining the correct patient for a trial require a significant output of time and effort from sites.
Ravi views site efficiency drastically increasing in the next five years as the usage of tech increases to analyze existing data and pre-determine the best candidates for trials.
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Terri agrees that health systems will be an important asset for many sponsors. She expects to see large existing networks of clinical trial hospitals make an effort to reduce individualized costs to maximize enrolment efficiency. In addition, Terri also said, “as health systems become increasingly financially responsible for patients lives, the data they have will become more comprehensive, extractable and shareable”. This will make them far better equipped to perform registry-based randomized clinical trials.
Ravi also highlighted the challenges sites face when finding and enrolling patients due to their location. For example, he notes that “requiring participants to complete qualification tests on site at the research facilities ends up filtering out a lot of potential patients because it’s too difficult on the part of the participant”.
For many patients, some of whom can be very sick, the requirement to get on a plane just to see if they qualify is a risk they aren't keen to take.
Ravi believes that a natural solution to this is “a shift towards remote strategies… to ease the burden on the subjects themselves”. By using remote facilities that are local to potential patients to run necessary tests, he believes that trials will be able to “activate faster and increase the number of participants that could take advantage of potentially life-saving treatments or drugs”.
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Although the industry is looking to maximize efficiencies; Teri believes that for many companies the focus will be on "leveraging existing communities and networks to shorten the operational aspects of trial design and activation”.
Lastly, Teri hopes that the next five years will be transformative for clinical trials. She predicts that we will see “increased adaptive randomization in trials to enhance the accuracy and speed of determining results to the root questions of clinical trials”. She also thinks “by streamlining operations and easing the existing pain points of multi-site and multi-network research sites, we’ll start seeing more attainable approaches to complex studies, such as biomarker and precision-based health”.