A recent analysis of over two decades of data from over 20,000 US-based clinical trials found that less than 44% of trials reported ANY race or ethnicity data6.
This corresponds to about 4.7 million participants6.
Global regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) utilize the answers provided by clinical trials to evaluate the safety and efficacy of novel therapies, inform medical professionals on the use of new therapeutic agents and make approval decisions3.The importance of clinical trials to provide evidence regarding pharmacokinetics/pharmacodynamics, safety, and efficacy of potential treatments across different demographic populations can’t be overstated3.
When clinical trials fail to include racial and ethnic diversity into medical research, it can be harmful for large segments of the population – especially if these trials involve the research of new drugs or combinations of drugs, new ways of doing surgeries or improvements to existing treatments. Clinical trials that only focus on a subset of the population can lead to medical advancements that only work for some people by ignoring the diverse genetic, environmental, cultural and lifestyle factors that play a key role in the development and treatment of medical conditions.
Depending on the topic of the study, different populations of people may be recruited as test subjects. Some studies may only require healthy volunteers, some may look at diseases primarily occurring in just men or just women, while others may have an age restriction1. But even with such variations in study populations, diversity and racial representation in clinical trials is particularly important. Historically, there has always been a vast imbalance in racial representation in clinical trials and certain racial and ethnic groups of people have not been well represented2.
To combat this, the U.S. Congress passed the National Institutes of Health Revitalization Act in 1993 as a means to improve the enrollment of minorities in clinical trials6. This policy was subsequently updated in the year 2000 to require the inclusion of women and minority groups in all “biomedical and behavioral research projects involving human subjects” unless there was a clear justification for their exclusion12. Other national and international efforts to increase and facilitate greater diversity in clinical trials included the Federal Drug Administration Race and Ethnicity Guidance, as well as the International Conference on Harmonization Guidance4. Yet, even with such measures and calls for the inclusion of racial/ethnic minorities and women in late-phase clinical research studies, these minority groups remain vastly underrepresented.
In fact, 92% of participants in clinical trials conducted back in 1997 were Caucasian and in 2014, this figure was still at a resounding 86%7.
People may experience the same disease and its treatment very, very differently. Including people from a variety of backgrounds and living conditions, as well as acknowledging features like race and ethnicity means that all communities could potentially benefit from scientific advances. It has long been known that population differences in disease prevalence, pathophysiology, and outcome can often be attributed to a variety of factors, such as genetic differences in cases of cystic fibrosis, sickle cell disease, or breast cancer suppressor gene abnormalities for instance7. Differences in biomarkers, such as estrogen receptor positivity or negativity in breast cancer, environmental differences, lifestyle choices, like tobacco use or a sedentary routine, and social factors can all differ amongst different races and ethnicities7.
Most recently, COVID-19 vaccine trials fundamentally highlighted these disparities. While African American individuals represented 21%of COVID-19 deaths in the United States, they made up only 3% of major vaccine trial participants6.
Racial and ethnic gaps in data collection can significantly skew medical evidence and its associated innovation towards therapies that lack appropriate efficacy and safety measures for minority populations6. Clear mismatches between the populations being studied and those on which therapy will be focused on, exist more often than we know.
One particularly eye-opening example of the consequences that result when representative populations are omitted from clinical trials are the recommendations that were made after a large-scale trial examined the effect of the drug tamoxifen on breast cancer prevention8.
13,388 women were studied over a span of 5 years – of which only 220 were African American (a group with a slightly lower breast cancer incidence, but a higher mortality) and 249 women were other unspecified minorities8.
Even though the number of included minorities was extraordinarily low, the published guidelines suggested that African American women should be counseled against preventative therapy with tamoxifen when 10 years younger than non-AfricanAmerican women9. Such recommendations can clearly be potentially dangerous to a whole subset of the population, and in fact, subsequent studies showed that tamoxifen therapy was equally as effective in African American women after all10.
There are more than 100 types of cancer affecting every type of cell known to man. Unsurprisingly, oncology makes up the majority of clinical trial research worldwide.
At LARVOL, following oncology clinical trials is our bread and butter! We strive to make clinical trial data as accessible and simple to follow as possible. For more information, request a demo here!
Cancer can affect each and every one of us. It affects people of all races, ethnicities, genders, and ages. It is important to consider health disparities, including health outcomes influenced by unequal access to health insurance or differences in the incidence and survival rates for people with cancer that exist among racial or ethnic minority groups3.
Certain minority groups report a higher incidence of certain cancers.
For instance, multiple myeloma, colorectal cancer, triple negative breast cancer or prostate cancer all occur disproportionately more often in African American individuals3. While others, such as gastric cancers are more prevalent among Asians and Pacific Islanders3.According to the CDC, African American men have more lung, prostate, colon, and rectal cancers than Caucasian men and, overall, AfricanAmerican men have more malignant tumors and are less likely to survive cancer than the general population11.
Particularly, considering that for clinical oncology trials conducted in the United States, the distribution was still heavily skewed towards Caucasians (84%) – with minimal representation of African Americans(7.3%), Asians (3.4%) and Hispanics/Latinos (2.8%) based on literature published in 20193.
To promote social justice and health equity and ultimately produce more innovative science, including a diverse range of people from different communities in clinical oncology trials is of vital importance and much work still remains to be done moving forward.
Diversity in clinical oncology trials matters because it promotes equitable access to effective cancer treatments, helps identify differences in treatment responses among diverse patient populations, and can help reduce health disparities.
Some strategies that may encourage increased participation of minorities in clinical trials include:
Overall, increasing diversity in clinical trials is a multifaceted process that requires a combination of steps, so we as healthcare providers can move towards ensuring equitable access to effective treatments for all populations.
Both on the side of the research scientists trying to connect with people from different cultures, as well as their participants.
79% had reduction in disease. ORR 31%. Many responses deepen over time.
Toxicity profile was in line with prior TIL/Lifileucel data. No surprises here. Median # doses of IL-2 was 6.
Absolutely agree!… this should be available to our melanoma patients ASAP!… and paves the way for smarter cellular therapies to be designed, studied, and eventually widely disseminated
Just before I start AM clinic at @cityofhopeoc, excited to share results from #COBALT_RCC, a P1 trial of @CRISPRTX#CTX130 in #kidneycancer in the @sitcancer#PressProgram. Will present more on Thurs 5:37p at #SITC22! Thx @neerajaiims@DrBenTran@HaanenJohn#SamerSrour& co-Is! t.co/aDnhG9n92A
@montypal@cityofhopeoc@CRISPRTX@sitcancer@neerajaiims@DrBenTran@HaanenJohn@DrChoueiri@TiansterZhang@tompowles1@brian_rini@AlbigesL@Uromigos@ERPlimackMD@drenriquegrande@PGrivasMDPhD Congrats Monty! Looking forward to hearing about this exciting first-in the field study!
CAR-Ts are coming for #kidneycancer!! Congratulations @montypal and team; can’t wait to see results at #SITC22! t.co/9MrlF2yzBe
Congrats @montypal and team! Great to see CAR T therapy coming to #RCCt.co/ypRHBC89Pt
Another huge step from none other than @montypal!! CAR-Ts in #kidneycancer!Congratulations to the entire team!Looking forward to seeing the results at #SITC22! t.co/HvKeVBPyV7
@montypal you never stop to amaze me! You are brilliant & awesome! Looking forward to hearing more about this trial @sitcancer@OncoAlert@CityofHope_GU@COHMDCareers@neerajaiims@KidneyCancer@KidneyCancerDoc@NazliDizman@ZeynepZengin@LuisMezaco@crisbergerot@PauloBergerott.co/RNzOwxixQm
Artificial Intelligence (AI) has emerged as a transformative technology with the potential to revolutionize various industries, including medicine. One of the most prominent applications of AI in healthcare is the use of ChatGPT, a sophisticated language model developed by OpenAI.