DIVERSITY IN CLINICAL RESEARCH
WHY DIVERSITY IS NEEDED
Without clinical trials, we would not have new medicine, and it is unethical and dangerous to approve drugs without making every attempt to certify their safety and efficacy. Yet by failing to include members of racial and ethnic minorities in clinical trials, that is just what the FDA is doing. The FDA has approved drugs which were proven to be safe and effective for overwhelmingly white study participants. However, we found out later that these drugs do not necessarily work the same for minority populations. For example, clopidogrel, an anti-platelet drug, is no better than a placebo for 75% of Pacific Islanders who take it. The most common asthma-controlling medications were approved by the FDA based on how they performed in studies that included mostly white people, but later studies showed that they often don’t work as well for Puerto Ricans and African Americans, who have the highest rate and greatest severity of asthma. Carbamazepine, a drug used to treat seizures and nerve pain, is more likely to cause Stevens-Johnson syndrome in Asians than in other racial groups.
Kalo Clinical Research is dedicated to ensuring that ALL have a seat at the drug development table by doing the following:
Ensuring participants are adequately compensated for their time and travel expenses when they enroll in a trial (discussing the Ensuring Access Act, which deducts the first $2,000 a patient receives for clinical trial participation from federal benefit eligibility determinations).
Allowing for patient payment/reimbursement methods that best serve the patients
Providing dedicated coordinators who are assigned to each participant (one-on-one support) through the length of the trial to personalize support for travel, financial reimbursements, pandemic-related issues, relocation services, and other logistical support they may need.
Providing/training investigators (physicians) and staff that are racially and ethnically diverse and partnering with other organizations committed to the same goal.
Community outreach to educate and build relationships in underrepresented demographics.
Direct communication with patient advocacy groups, patients, caregivers, and physicians about the scientific importance of diverse representation in clinical trials
Providing direct support to patients from enrollment through the end of the trial to help ease the financial, logistical, and psychological barriers to participation.
The goal of all clinical trials should be to represent the affected population as a whole. Because most medical conditions are not specific to a single demographic, sample populations should not be either. Ethically, a lack of representation in trials raises concerns about ensuring equal access to new treatments and cures. A person’s socioeconomic status or demographics should not exclude them from participating in a clinical trial or from being assured the approved treatment will be safe and effective for them once approved.
Historically, 60-70% of clinical trial participants have been white males because they were the ones who could afford the cost of travel and the time off work to participate. Today, ethnic diversity in clinical trials continues to be an issue. Although minorities make up nearly 40% of the U.S. population, they constitute less than 20% of participants in key clinical trials that lead to the approval of new medicines. Further broken down, in the United States, African Americans make up 13.4% of the population, but only 5% of clinical trial participants. Hispanic or Latinos make up 18.1% of the U.S. population, but only 1% of trial participants. Asian Americans account for 6% of the population, and only 1% in clinical trials. Two out of three clinical trials are absent any Native American participation.
Even more specifically, Asian, Latino and Black Americans make up about 35% of the Type II Diabetes patient population in the U.S., but less than 20% of available medicines in this class were studied in all three populations. Up to 75% of Pacific Islanders are unable to convert an antiplatelet drug into its active form, leading to a higher risk for adverse outcomes following angioplasty. African American men are twice as likely to die from prostate cancer than whites but represent only 4% of prostate cancer clinical trial participants.
Such lack of diversity is not limited to U.S. trials, as a recent study of trials across 29 countries over the past 21 years shows that 86% of participants were white. This disparity is concerning because it is scientifically crucial to understand how a new drug or therapy affects patients of varying ages, genders, and ethnic backgrounds, as reactions to many new treatments are proven to differ depending on the individual’s demographics. For example, African Americans react differently than white populations to certain blood thinners and asthma medications.
HOW YOU CAN MAKE AN IMPACT!
Proportional representation in clinical trials helps to accurately understand how or if a drug affects a particular demographic group negatively or differently. More investigation can then define the issue or address it before the therapy receives approval. Representation is essential because once a drug is commercially available, access will not be restricted to certain demographics, so a clear understanding of each demographic’s reaction is an imperative before going to market.