Increasing Clinical Trial Diversity – The Right Technologies and Strategies for Reaching Underserved Patient Populations
The clinical trial industry has historically been slow to change. Clinical trials are complex, so it is understandable that researchers continue to use methods and processes they feel help them successfully conduct studies. This often means reusing clinical trial sites and site networks, working with the same technology partners, and recruiting from the same populations of patients. Comfort and convenience, however, can result in a lack of innovation. Worse, it can mean a failure to study truly representative populations of patients. This lack of diversity among clinical trial participants casts doubts on the safety and efficacy of new therapies for patients outside study cohort demographics.
It often requires the intervention of outside parties for the industry to accept a need for broad changes. So, it should be no surprise that in January 2023, United States legislators formally stepped in to require diversity action plans for all clinical trials overseen by the Food and Drug Administration (FDA).1 This was made law when it was written into the 2023 omnibus spending bill2 and takes the demographics reporting requirements included in the DEPICT Act (introduced in 2022)3 a step further.
The Time is Now for Improved Diversity in Research
The new law means that all researchers need to submit their plans for ensuring a diverse study to the FDA. If a sponsor wishes to limit the reach of a given study to a more homogeneous pool of patients, they must present a rationale to the FDA and seek its permission to move forward. Truly, there is no longer an option to apply the same old processes if those processes do not make room for all patients. But to identify the best strategies and solutions for addressing clinical trial diversity, we must first address the biggest roadblocks to more representative trials.
The most obvious challenge to reaching broader groups of patients is geography. Clinical trial sites are – and will continue to be – critical to research success. But trials that require frequent site visits from patients will, naturally, attract more participants living within reasonable proximity to a study site. This, of course, locks the study into enrolling patients from limited regional demographics.
Perhaps a subset of the geography discussion, predominantly regional patient recruitment locks studies into using populations from homogeneous socioeconomic statuses. Many patients may not have the financial means or transportation access necessary to visit study sites.4
Finding the Right Solutions for Reaching More Patients
Spurred by the COVID-19 pandemic and guidance from the FDA5, the use of decentralized clinical trial (DCT) elements has grown considerably in recent years. These approaches allow for remote data collection via a number of tools. While this list includes specific medical devices that can be used by patients in their homes like wearables, blood pressure monitors, and more, the vast majority of DCT approaches require one common tool – a smartphone or similar device.
Through native mobile apps, patients can submit a variety of important data such as eConsents and ePROs and can also engage directly with their study team through chats or video visits. The ability to collect highly accurate study data remotely means researchers can infinitely expand their reach to build truly representative patient populations. While many trial applications allow patients to use their own smartphones (bring your own device, or BYOD), for some patients, sponsors may want to provide smartphones or similar devices. They may even consider paying to ensure internet access for participants from underserved communities. This investment seems low compared to the cost of lengthy recruitment periods, not to mention poor showings with the FDA should they deem a sponsor’s diversity efforts to be insufficient.
Mobile Technologies to Facilitate a Successful Diversity Strategy
As researchers seek to include the broadest possible patient populations in their clinical trials, mobile solutions will become the standard. Their ability to not only collect data but to facilitate patient engagement – all while significantly reducing (or even eliminating) problems like manual transcription errors and source data verification – make it vital for sponsors to adopt solutions that fit both current and future study needs.
The TrialKit platform has been built with this in mind. TrialKit makes it simple for researchers to build their study to reach anywhere in the world and has helped sponsors collect data from and engage with patients in extremely remote locations in Africa, Japan, and even Antarctica. Using TrialKit, sponsors can easily build out an end-to-end, cloud-based platform for all study needs including EDC, eSource, eCOA, virtual visits and more. Further, TrialKit allows for engagement in multiple languages. All this allows researchers to be confident that they can effectively reach a wide array of patients, no matter where they are in the world.
Mobile strategies are key to reaching a broader, more diverse group of clinical research participants. But patients are not the only research stakeholders that benefit from mobile access. While there are a variety of solutions that allow for remote data collection via a mobile device (e.g., eCOA, eConsent, etc.), only TrialKit allows researchers mobile access to their electronic data capture (EDC) platform. The solution applies proprietary technology to enable fully interchangeable use of both browser-based and mobile applications. This means that any data collected, any protocol changes, or any new information entered at all, is reflected in the database in real-time.
Study team members can access data from wherever they are, confident that what they are seeing is accurate and up to date. Whereas with other EDC platforms, researchers may be limited to viewing study status when they are in front of a work computer. This can result in being hours or even days late to respond to a serious problem. With mobile EDC access, study teams find out about patient issues when they occur, allowing them to intervene immediately to protect the safety of the patient. This also helps patients to feel supported, reducing the risk of dropouts.
There is no longer any reason for researchers to wait on deploying new strategies for increasing clinical trial diversity. With diversity planning now mandated by U.S. law, sponsors conducting studies in the U.S., which includes the vast majority of sponsors, must take steps to move the needle when it comes to recruiting and enrolling more representative pools of patients. To accomplish this, study leaders can rely on flexible, end-to-end solutions that provide for remote data collection and access via mobile devices like smartphones. Solutions like TrialKit that make building more inclusive studies simple while maintaining the ability to pull in data from a growing list of sources, will help sponsors meet the call of U.S. lawmakers and develop therapies that are safer and more effective for the broadest possible population of patients.
For more information on TrialKit, please visit crucialdatasolutions.com.
1 Baumann, J. (2023, January 19). Diversity in clinical trials at FDA gets a boost from new law. Bloomberg Law. https://news.bloomberglaw.com/pharma-and-life-sciences/diversity-in-clinical-trials-at-fda-gets-a-boost-from-new-law
2 H.R.2617-Consolidated Appropriations Act, 2023; 117th Congress (2021-2022); https://www.congress.gov/bill/117th-congress/house-bill/2617
3 H.R. 6584 – DEPICT Act; 117th Congress (2021-2022); https://www.congress.gov/bill/117th-congress/house-bill/6584?s=7&r=6&q=%7B%22search%22%3A%5B%22DEPICT+diversity%22%5D%7D
4 Sharrocks K, Spicer J, Camidge DR, Papa S. The impact of socioeconomic status on access to cancer clinical trials. Br J Cancer. 2014 Oct 28;111(9):1684-7. doi: 10.1038/bjc.2014.108. Epub 2014 Aug 5. PMID: 25093493; PMCID: PMC4453719.
5 2023. Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Guidance for Industry, Investigators, and Other Stakeholders. https://www.fda.gov/media/167696/download