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article imageQ&A: Tackling underrepresentation in clinical trials Special

By Tim Sandle     Nov 20, 2019 in Science
Today’s clinical trial and research space faces a number of challenges, including limitations in data quality and trials that effectively address underserved populations, impacting the efficacy of drug benefits and treatments of complex diseases.
To understand the complexities in more detail and the importance of targeting underserved populations, Digital Journal spoke with Mark Blumling, CEO and founder of Headlands Research, a recently formed KKR-backed company.
Six research sites are now under Headlands Research, located across Georgia, Louisiana, Texas, and Canada. These target trial participation specifically in the Hispanic and African-American populations, and have a particular focus on complex diseases addressing the Central Nervous System (including Alzheimer’s), immunology and oncology -- conditions that thousands of Americans are diagnosed with every day.
Digital Journal: How important are clinical trials for drug development?
Mark Blumling: Clinical trials are a critical, federally mandated final step in the drug development process to test new drugs to ensure intended efficacy and safety in humans.
DJ: What are the main challenges when a clinical trial is set up and what is meant by a clinical trial being ‘underserved’?
Blumling: The risk of underserved clinical trials means that the required patient populations aren’t represented in a trial that is meant to optimize drug treatment regardless of factors such as age, ethnicity and geographic location. Headlands Research is particularly focused on increasing ethnic minority and older populations in clinical trials.
DJ: What are the consequences for the medicine from an underserved clinical trial?
Blumling:Differences, such as drug metabolism, risk impacting the drug efficacy if participation in a clinical trial is either skewed or underrepresented by the populations that the drug is meant to serve.
DJ: What can be done to ensure clinical trials are more representative and what is Headlands Research aiming to do to improve the situation?
Blumling:Headlands Research focuses on increasing diverse patient representation by locating clinical trial sites in non-traditional areas where there are large minority populations. For example, our sites across Texas, Louisiana and Georgia are in locations with high percentages of Hispanics and African Americans, which will allow us to facilitate trials that access these populations. Our site in British Columbia, Canada, is in an area with a higher percentage of older patients, allowing drug trials in Central Nervous System (CNS) conditions like Alzheimer’s Disease.
We are focusing on having sites of the highest quality, expedited study start-up, patient retention, and specialty and diverse patient access. All of our sites are fully owned, and our embedded and dedicated site models allow for maximum subject access. We have more than 75 expert clinical research professionals spanning six states and Canada, who combined have completed more than 1,000 Phase I – IV studies. We expect these numbers to grow during the coming months and years.
[DJ explanation, with clinical trials - Phase I: Testing of drug on healthy volunteers for safety; involves testing multiple doses (dose-ranging); Phase II: Phase II: Testing of drug on patients to assess efficacy and side effects; Phase III: Testing of drug on patients to assess efficacy, effectiveness and safety; Phase IV: Post marketing surveillance – watching drug use in public]
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