It’s notoriously difficult to recruit people to participate in clinical trials. It’s even harder to ensure that trials are ethnically, racially, and socioeconomically diverse. The idea of paying people to participate has been floated as an option to improve recruitment, but I believe fundamental problems in the clinical trial mechanism need to be addressed before moving in that direction.
Clinical trials couldn’t exist without people who are willing and able to dedicate their time — and trust their care — to the research community. Yet a number of barriers stand in the way of widespread participation.
A general lack of awareness about clinical trials makes it challenging to reach people who could benefit from emerging research. Trials are often based at academic medical centers, which excludes individuals who can’t easily get to these locations. And taking part in research requires following regimented treatment and observation activities, which can be difficult for people busy with work and family lives.
The result is chronically low enrollment rates, skewed demographics, and increasing disparities between those who can afford to participate in research and those who cannot.
Clinical trials shouldn’t be accessible only to those with the financial security, mobility, and health literacy to join them. Producing therapies that work in the real world means including individuals who are representative of the populations that new therapies are intended to treat.
Experts have proposed various ways to expand the reach of clinical trials and include more diverse and representative groups. To some, including John Whyte, WebMD’s chief medical officer, the most obvious answer is a financial one: pay people to participate. Doing that, he argues, would increase interest and boost enrollment rates. Participants could reap concrete rewards from commoditizing their data while also contributing to society’s medical knowledge. Wouldn’t everyone benefit from that?
Maybe not. There is no question that compensating trial participants for their travel expenses or providing child care options are right things to do. Participants invest an enormous amount of time and effort in clinical trials, and they cannot be asked to operate at a loss — while generating valuable information — and follow complex protocols to a T.
But offering additional financial incentives starts trial sponsors and research organizations down a slippery slope. Establishing the legal and ethical guardrails to prevent exploitation, cherry-picking patients, and distorting clinical outcomes would be a monumental undertaking. More importantly, offering financial incentives for clinical trial participation minimizes the lessons learned from the Tuskegee syphilis study which led to the establishment of the federal Office for Human Research Protections.
Instead of focusing on paychecks that go beyond reasonable compensation for expenses, sponsors, research organizations, and others need to invest time and effort to develop more holistic approaches to modernize and enhance the clinical trial ecosystem. Developing innovative trial designs and reducing the burdens of participation can ensure that breakthrough therapies reach the communities that need them most.
Redefining the role of clinical trials in the patient journey
Radically shifting the common perception of clinical trials can sustainably increase enrollment rates. Many patients — and their providers — think of clinical trials as last-ditch efforts after all other avenues have failed. Instead, people should be encouraged to think about clinical trials, when available, as an integral part of their care, especially for life-threatening and serious diseases such as cancer.
Building a network of education and support around individuals and clinicians can ensure that potential trial participants are informed about their opportunities, feel empowered to contribute to ongoing research, and are equipped with the tools to make the best decisions for their own health. One approach to doing this would be working with community organizations and physician groups to develop educational materials and provide social support for patients, both in the clinic and at home. Examples include holding community educational events, forming clinical trial support groups, and providing assistance for travel and child care.
Such education and outreach efforts would likely increase participation among populations who simply didn’t know clinical trials are an option for them.
Reducing the burdens of participation with innovation
Clinical trial sponsors must also make a coordinated effort to eliminate logistic burdens that prevent participation in trials. Decentralized trials that use telehealth, smartphones, home-based medical devices, local health care providers, and other technologies could help meet patients where they are, whether that’s in the mountains of rural Idaho, the suburbs of Atlanta, or a transportation desert in the Bronx.
Not asking participants to travel far or often can decrease their out-of-pocket costs, save them time, and improve their overall experiences in clinical trials. The magnitude of cost and time savings may circumvent the need to use financial compensation as a lever at all.
Another innovative clinical trial design that sponsors should consider, especially with regard to rare diseases, for which enrollment is chronically challenging, is to use real-world data to supplement clinical trial data. In this model, real-world clinical data can be used to generate an external control arm, thus decreasing overall enrollment needs. Real-world data also offer insights into how diverse populations experience disease and achieve specific outcomes.
Infusing real-world data and real-world evidence into the clinical trial process can support deeper exploration of key clinical issues and add a better understanding of real-world patient experiences and outcomes.
Combining better education and support with innovative strategies for clinical trial design and delivery can avoid the thorny issues of incentives and inducements while extending the rewards of cutting-edge research to all.
C.K. Wang is the chief medical officer of COTA, a data company focused on cancer.