Gary A. Puckrein, Ph.D., president and CEO of the National Minority Quality Forum (NMQF), has presented an award to John Castellani, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), for his demonstrated leadership to increase diversity in clinical trials. On behalf of PhRMA, and in conjunction with NMQF, Castellani spearheaded the "I'm In" campaign to build awareness, start conversations, and increase diversity in clinical trials, especially among African Americans, Asian Americans and Hispanic populations.
"Through his remarkable leadership in ensuring safety and efficacy testing for new drugs include minority Americans who have traditionally been underrepresented in clinical trials, John Castellani is paving the way for the nation to develop a set of comprehensive guidelines that will, for the first time, reflect the diverse population for whom they serve," said Puckrein.
When a potential new medicine is developed, researchers must prove safety and effectiveness through clinical trials before the medicine is approved by regulatory agencies, such as the FDA. Traditionally, individuals volunteer for clinical trials at the behest of their physicians, but physician referrals alone are often insufficient to attract a large and diverse group of volunteers.
"Despite making up 13% of the U.S. population, African Americans only represent about 5% of clinical trial participants, and Hispanics, who comprise 17% of the U.S., account for a mere 1% of participants," said Puckrein. "A wide variety of clinical trial participants is critical to adequately assessing whether or not a drug is safe and effective on different populations, and John Castellani is the first person to truly work towards turning the tide on this risky practice."
The "I'm In" campaign, conceptualized by John Castellani and co-founded by PhRMA and NMQF in March 2014, was created to bridge this awareness gap and encourage minority Americans to participate in clinical trials.
"Only once we include all members of our society in the testing phase of new medicines can we hope to effectively connect patients with the medicines they need, and John Castellani has planted the seed that will get us there," said Puckrein.