Life-sciences analytics company Clarify Health recently launched Clarify Trials, a cloud software platform that uses real-world data (RWD) to help trial teams accelerate clinical trial recruitment within underrepresented communities. It reportedly provides more than 400 social determinants of health (SDoH) insights to assist in the identification of research and investigators with the greatest potential to enroll diverse patient groups.
Outsourcing-Pharma recently connected with Kenneth Park, senior vice president and general manager of life sciences solutions at Clarify Health, to discuss how clinical trial analytical technologies have advanced, challenges associated with inclusive recruitment, and how the new software might help.
OSP: Could you please talk about the evolution of advanced analytical technologies used in life sciences in general, and in clinical trial recruitment more specifically?
KP: Over the last 15 years, the life sciences industry moved away from manual data management and analytics on isolated servers, increasing its use of real-world data, advanced analytics, and cloud software solutions. The traditional process for selecting clinical research sites has been to look at historical performance. However, to advance diversity and inclusion in clinical trials we need to use real-world data to determine a site’s ability to recruit underrepresented patients.
OSP: Please tell us about some of the challenges around recruiting more diverse patient populations, and how the use of advanced analytics could help increase the success of recruitment efforts.
KP: Diverse patient populations, whether defined by race, ethnicity, gender, geography, or socioeconomic factors, have historically been underrecruited. This is a multifactorial issue that can be driven by proximity to trial sites, cultural preferences, health literacy, language barriers, income, access to transportation, or the ability to take time from work to receive care.
Advanced analytics that include social determinants of health insights that assess these factors can help life sciences companies ensure the people most in need are included in clinical research.
OSP: Could you share your thoughts on the FDA’s newest guidance about enhancing trial diversity?
KP: As life sciences companies and clinical research organizations (CROs) navigate the FDA’s 2020 guidance to enhance diversity in clinical trials, they are seeking solutions to proactively reduce health disparities without unnecessary trial delays, budget overruns, or protocol amendments. The ultimate goal is to demonstrate the efficacy and safety of products in a diverse population rather than a historically more homogenous one.
OSP: Please tell us about Clarify’s latest software solution, and exactly how it can help trial teams recruit and enroll a larger number of patients from underrepresented groups.
KP: Clarify Trials is a real-world evidence-based software product that empowers life sciences companies to accelerate the recruitment of underrepresented patient populations. With the software, clinical operations teams can identify research sites and investigators with the best opportunity to enroll diverse and hard-to-find patient populations, leveraging Clarify’s patient journey data across over 300m lives and over 400 social determinants of health (SDoH) insights.
If clinical trials continue to engage with historical clinical trial sites in the same ways with the same investigators, then they can expect the same recruitment patterns. Often, underrepresented patient populations are not receiving care at traditional trial sites and have no points of interaction to even be recruited.
Clarify Trials highlights new engagement touchpoints into underrepresented patient populations by mapping PCP and specialist referral patterns into defined care networks. Study teams are then able to identify physicians treating diverse communities and build stronger community outreach programs, establish new sites, or engage with new investigators.
OSP: From your perspective, why is it important to increase representation in trials?
KP: Clinical trials are the evidence that a drug will be effective and safe in a patient population. Given the diversity of the US population, it’s important that clinical trials demonstrate the same clinical endpoints across an equally diverse study population.
In addition, as pragmatic clinical trials look beyond the science of the drug into the effectiveness of how therapies are delivered, it’s equally important to look at the drivers of healthcare disparities and identify opportunities to address them.
OSP: Anything to add?
KP: I joined Clarify in September to accelerate the growth of the life sciences business. I’m excited about the potential of giving life sciences companies on-demand access to explore precise patient cohorts.