Using Data to Improve Minority Trial Recruitment
A recent news headline by Reuters: “Modern vaccine trial contractors fail to enroll enough minorities, prompting slowdown”
The COVID-19 pandemic has shed new light on a decades-old problem related to recruitment in clinical trials: under-enrollment among racial and ethnic minorities. In order to truly understand the efficacy and safety of new medicines, including COVID-19 vaccines and therapies, as well as generalize research findings, a cross-section of the population needs to be fairly represented. Genetic differences by race and ethnicity have a profound impact on study results and a varied study patient cohort can get pharma closer to the truth during the clinical trial, rather than waiting for post-approval safety monitoring to identify differences by race and ethnicity.
Complex and multi-level barriers to enrolling a diverse population of patients in clinical trials include:
- A lack of awareness of study availability, process, costs, and value of participating
- A limited number of locally/regionally located trial sites
- Language and cultural barriers
- A minority individual’s bias, based, e.g., on past experience
There are many more system/individual-level reasons for the under representation of minorities in clinical trials. Pharma is investing valuable resources to change the paradigm and perception of under-represented populations, while working to increase minority participation in clinical trials.
COVID-19 has escalated the issue, especially as, according to the FDA, pharma vaccine investigators advance their candidates from Phase 2, with 150 or 200 patients, to Phase 3 trials where the top vaccine candidates are recruiting anywhere from 30,000 to 50,000 patients, and most importantly, look for an optimal cross-section of population. At no time in the history of our country or modern medicine has it been so important to study a true representation of our nation’s population. It’s crucial that we understand how these new COVID-19 vaccines will react from an efficacy and safety perspective across different races and ethnicities.
Real-time, real-world evidence is key to solving the minority trial recruitment problem. There is a proven solution available today that accelerates the gathering of data that supports the trial recruitment efforts, increasing pharma’s access to minority patient and physician clusters. These solutions, crucial to COVID-19 research, may be a long-term solution to the life science industry as a whole, for all drug trials and research.
MSA Healthcare Data Management Solutions is the expert and market leader in providing Anonymous Patient Level Data (APLD) to the Life Science Industry. Using patented, HIPAA-compliant technologies to de-identify and link lab and other patient data, MSA can enhance your vaccine trial recruitment of minority populations by giving you visibility to physician and patient clusters.
For nearly two decades, MSA has been solving healthcare data management problems with patented, state-of-the-art technologies that help pharma see an up-to 360ﹾ view of the patient journey.
As the market leader, MSA HCDM offers pharma the most credentialed, most configurable, and most trusted HIPAA-compliant de-identification and matching solutions. The unparalleled service provided by MSA’s team of healthcare data management experts ensures the timely delivery of the highest quality data – the differentiating factor that many top life science companies rely on.
MSA’s structured methodology for integrating, protecting, and transforming disparate data from one or multiple sources into high-quality, longitudinally-aligned datasets leads to the actionable insights pharma requires to improve patient outcomes, reduce healthcare costs, and drive innovative research.
MSA’s Data@Factory links de-identified, MSA-provided Lab, Medical Claims, and EHR Clinical Data with other disparate data from one or more sources, providing a longitudinal anonymous patient-level database for sophisticated data analytics of the comprehensive patient journey.
As pharma continues to look for innovative ways to improve minority patient trial recruitment, access to data and information is even more critical.