The call for greater diversity and inclusion in clinical research has been heard, with FDA guidance, the establishment of cross-industry initiatives and new businesses solely focusing on increasing participant diversity. But, what about the diversity and inclusion of the researcher community? While many are quick to label the absence of minorities and women in clinical research as a “pipeline problem,” we believe there are other clear and present barriers  that warrant a more urgent response from the life sciences community.

 

Despite comprising 40% of the U.S. population today, racial and ethnic minority groups are highly under-represented in clinical trials. In 2020, 75% of the 32,000 clinical trial participants investigating 53 new drugs approved by the FDA were White individuals. With closer scrutiny on diversity and inclusion from regulatory bodies, as well as the mounting evidence that factors such as ethnicity and social determinants play a huge role in drug efficacy and medical outcomes, it’s worth noting that researcher diversity is an important factor that can affect participation in clinical studies and the development of novel therapeutics that benefit all patients.

 

Our white paper outlines the impact of researcher diversity on overall diversity and inclusion in the clinical research ecosystem, and further, identifies specific barriers that prevent a more diverse cohort of researchers from pushing the boundaries of scientific and medical knowledge. To us, it became clear that the barriers to entry for researchers across the ecosystem are simply too great, whether they are economic, technological, or cultural.

 

Money, money, money

 

Clinical research is an expensive endeavor, and often with good reason-investment into the development of new therapeutics, devices or interventions is a risky process, from start to finish. And while large coffers can offer a buffer to de-risk the likelihood of negative results, failed approvals or delays,  high barriers to economic entry leave the majority of researchers at smaller outfits or at the beginning of their careers “locked out”. Price sensitivity certainly exists in the researcher community, but often fails to account for researchers that do not have the backing of large institutions or funding organizations, access to startup funds for feasibility and pilot studies, or the network and mentorship needed to successfully navigate building a well-funded research program. Furthermore, the most cutting edge technologies, like tools for decentralization and virtualization, often take too long to achieve scale and percolate across the industry to all researchers - by that point, those that can afford it are already on to the next big thing. 

 

Without lowering these barriers, our industry risks stymying innovation among researchers that may not have the ‘hottest’ or ‘trendiest’ ideas. Often, this perpetuates the lack of resources for researchers seeking to innovate in traditionally under-funded and under-researched areas, such as maternal health and neglected diseases that disproportionately impact the developing world. We found ourselves asking: if increasing the diversity of researchers can ultimately benefit patients, what can be done to give these researchers an opportunity to gain the traction they deserve? 

 

The no and low-code movement needs to be incorporated

 

In the wake of the pandemic, technologies to support decentralized and digital-first approaches to research are no longer a “nice-to-have”- they are a must have. This is especially true if one considers how digital- or virtual-first methodologies can lower significant barriers to participation as compared to traditional, site-based clinical research, especially for vulnerable or underrepresented populations. With researchers across the spectrum, from post-docs to Fortune 500 pharma, investing in more digital methodologies and using cloud-based platforms, technological barriers are also rising. With a profusion of tools to manage clinical trials, often the purchase and management of these tools is inaccessible to a broader, unspecialized population beyond top pharmaceutical companies or contract research organizations. Even simple tools seem to require set-up and coding, or require purchase to even view. With so many industries embracing software-driven approaches, clinical research should embrace and invest in technologies that directly serve the audience interested in them - the researchers themselves. From free trials, to no or low-code environments, we believe in an approach that combines the best practices from user-friendly tools like Squarespace or even TurboTax with the rigorous and high quality approach required by the life sciences industry.

 

Who gets to be a researcher, anyway?

 

There are many routes to becoming a researcher, and many organizations in which a researcher can sit- including small pharmaceutical and nutraceutical companies, academic institutions, consumer and digital health teams, and patient-led advocacy groups. However, there are few tools that acknowledge and are built for researchers across these industries, resulting in highly specialized, niche  products that contribute to the economic and technological barriers mentioned above. Our traditional definition of who a ‘researcher’ is, particularly in the post-pandemic world, deserves to be reimagined. With this reimagining, we should welcome all those who seek to accelerate the cycle from research to care, or simply to better understand the everyday lived experiences of patients, regardless of their path to becoming a researcher. Moreover, individuals who engage with the healthcare industry, whether as patients or behavioral health app users or trial participants, have never been more discerning of the ways in which evidence is gathered and presented. We have much to learn from different types of researchers, and of course those who choose to participate in the research, if we are to continue to serve them all.

 

Democratizing clinical research with Smart Omix

 

Imagine a world in which a patient suffering from long Covid can quickly and easily conduct a fully decentralized study to crowdsource data on symptoms, physical activity and sleep patterns from other long Covid patients from across the US. Imagine a world in which a young physician-researcher can collect electronic patient-reported outcomes (ePROs) to determine the impact of a novel hospital discharge pathway for elderly surgical patients- simply by designing and sending scheduled survey instruments to the patients’ smartphones. And now, imagine a world where all of this can be done in a way that is highly accessible, intuitive, fast, and affordable. We are these researchers, and we did imagine this future. And now, we know that this reality is firmly within the grasp of the life sciences industry. 

 

Next week, Sharecare launches Smart Omix Researcher, a software-as-a-service (SaaS) product for conducting decentralized, smartphone-based clinical research. With Smart Omix Researcher, users can design, launch, manage and analyze mobile research studies to collect real-world data - all using a self-service, no-code interface designed for researchers, by researchers. Studies are configured using the web-based tool and then launched for participant enrollment in the companion mobile app, Smart Omix by Sharecare (available on iOS and Android).  By coupling a SaaS approach with decentralized methods, we hope to break down the technological barriers faced by researchers, reducing their reliance on engineering expertise and other point solutions to truly democratize the ability to conduct high-quality, digital-first research. Moreover, our tiered, license-based pricing model makes this affordable and within reach for all research budgets. In fact, users can sign up, prototype studies, preview them in the Smart Omix app and export the designs for free. Finally, we hope that this new solution will empower researchers of all stripes to find the answers to the questions that drive and challenge them, every day. 




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