One-third of the clinical trials that led to new cancer drugs approved between 2008 and 2018 didn’t report on the race of trial participants — and even studies that did report on race often had far fewer black and Hispanic cancer patients than might be expected, given the makeup of the cancer patient population.

That’s according to a new study, published in JAMA Oncology, that looked at 230 clinical trials that supported oncology drugs approved by the Food and Drug Administration. Of those studies, just 145 reported on at least one race of trial participants. Just 18 broke the data down by the four major racial groups — white, Asian, black, and Hispanic — in the U.S. The study’s authors say their findings highlight the clear need for better reporting and representation in cancer trials sponsored by the drug industry.

“It’s important to recognize that this problem is there and this problem is persisting over the years,” said Dr. Kanwal Raghav, an oncologist at MD Anderson Cancer Center and an author of the study.

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Megan Thielking/STAT Source: Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, JAMA Oncology.

For trials that did report on race, there were notable disparities in the makeup of participants. White patients accounted for 76% of study participants, while Asian patients accounted for 18%. But black patients made up just 3% of participants in clinical trials for approved cancer drugs during that time, and Hispanic patients accounted for just 6%. The proportion of black and Hispanic patients in cancer trials did improve somewhat during the decade the study examined, though not considerably.

Megan Thielking/STAT Source: Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, JAMA Oncology.

Black and Hispanic patients, in particular, were underrepresented in trials that led to cancer drug approvals. There were far fewer black and Hispanic patients in cancer clinical trials than would be expected, given the share of cancer patients who are black or Hispanic. Raghav and his colleagues say that’s problematic, particularly for trials that play a pivotal role in patient care.

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“When you come across clinical trials that establish FDA approval or standard of care [for a new drug], they should definitely be representative of the population it’s used to treat,” Raghav said.

Another striking finding: Different racial groups were more likely to enroll in different types of trials. White patients were more likely to enter larger, randomized, later-stage trials with multiple arms. Minority groups, on the other hand, were more likely to enter smaller, non-randomized trials with just one arm. It’s not clear why, exactly, that’s the case. But taken together, Raghav said the findings raise questions about what the disparities might suggest about how researchers recruit for and run clinical trials.

“You do a trial of cancer patients across the country, you should see that kind of proportional representation. If it’s not being done, why is it not?” he asked.

Megan Thielking/STAT Source: Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, JAMA Oncology.

The National Institutes of Health requires studies it funds to have racial representation that’s proportional to the patient population. But most human trials that contribute to drug approvals are funded by the drug industry. The Food and Drug Administration does recommend that trial researchers collect and report data on the race and ethnicity of participants and has also said study sponsors should enroll patients who reflect the patient populations that would benefit from the drug. But the findings show there’s room for improvement when it comes to representation in industry-sponsored research, Raghav said.

“The issue here is not where the funds are coming from,” Raghav said. “The issue here is doing the right thing. … There should be more efforts made to increase participation of all racial subgroups.”

  • My comments will be predicate on insufficient information or research with regards to this drug or medication there off . However due to or base on the climate . culture and or history of these drugs within the past ten [10] years or so i place very little confidence or faith with any of these Pharmaceutical Empires . In due course of time . after i have research and evaluate this one . i will then arrive at at final conclusion . I thank you . Trevor .Merchant .Bronx , New York City . Tuesday . August . 20. 2019 at .3.36 p.m day light savings time

  • As far as, from what I’ve witnessed, working within the clinical area of the field….

    No study that I’ve seen, has EVER had accurate representation of the population the drug is meant to help treat.

    Have you ever read the inclusion/exclusion portion of a study protocol? They’re so specific, and designed to eliminate the majority of the general population immediately; which is incredibly ironic when you think about it.

    Because ultimately, based off the results of the few people who do qualify to participate, the goal is to then market that drug to that masses (whom they excluded from participating in the study to begin with) like a one size fits all treatment. …. 🤦‍♀️

    It’s of no suprise, minorities are grossly uninvolved in the process. I’m sure it’s not by accident – not on the part of the companies manufacturing the trial drug and creating the protocols (rules).

    Just putting that out there

  • I work in oncology research. I think something that hasn’t been addressed is the lack of trust in research by these minority groups. Research is sometimes scary for minorities to take part in due to cultural and historic backgrounds. I will offer the same study to all races but, whites who are more educated seem to easily sign informed consent. Minorities or even less educated whites are more Leary or don’t “trust the system”. They “don’t want to be used”. They see it as a way for white men to “use” them. I don’t blame the researchers or the pharma companies! I blame education, history and trust issues. Single arm means everyone gets the drug or intervention. Fairness to people with trust issues! Short study again seems more “safe” than long trials. Complicated trials may not appear “transparent” if not understood. It is easy for me to see exactly why the under representation. Perhaps education would go a long way for minorities in this area. To blame the FDA or pharma is a scape-goat easy shot. Take a look at the background and there is a real clear path why minorities are under represented!! Tell minorities they need to volunteer! We can treat what we can’t see.

    • Your comment is an example of the role unconscious bias plays in limiting opportunity for minority patients to be asked to participate in clinical studies. Specifically your claim that: “I will offer the same study to all races but, whites who are more educated seem to easily sign informed consent. Minorities or even less educated whites are more Leary or don’t “trust the system”. They “don’t want to be used”. They see it as a way for white men to “use” them. I don’t blame the researchers or the pharma companies! ”

      In that statement you compare educated white people to minorities or less educated white people–grouping the latter two with the presumption it’s a monolith. You failed to share your experience offering trials to educated minority patients. How does that group behave relative to other educated people? Your logic is flawed here and it significantly weakens the point you’re trying to make.

      I agree that education about clinical research is important for all patients to make informed decisions about participation. I disagree that researcher and pharma don’t merit blame. The reason being–the unconscious bias you expressed in this Comment section as someone who works in oncology research is pervasive among researchers and industry alike, it impacts who is invited to participate, negatively effecting minority patients, and is a by product of Industry-defined research priorities as well as macro cultural issues in the US.

  • What does multiple arms mean? Also, “just one arm”? Also, I thought ALL trials were randomized. Where can I find non-randomized trials? We got randomized OUT of a trial after a lengthy qualification process and were not allowed the benefits of a very promising drug that is actually approved for use in Europe and Australia. Will appreciate your reply.

    • Single arm means all participants get the study treatment/drug or intervention. Multiple arms means people are randomly selected to go into different groups. One group may get study drug x the other “arm” gets study drug y. That is randomization with different or multiple “arms” or groups. Not all trials randomize patients. It depends on what and how the trial is set up. Sometimes everyone gets a standard treatment, but only some are randomized and get additional treatments. Or maybe all get the treatment. Randomization is the process of grouping in random order who gets what treatment and when. Sometimes all get treatment but at different timelines or doses or dependant on disease progression. Trials are set up according to the hypothesis. What are we looking to find and what is the BEST way to find out? I hope that helps!

  • I’ve worked in clinical research for almost 20 years. In the US, everyone should be documenting race, age and gender/sex in order to prevent homogeneous bias. But the real issue with cancer trials is that every piece is charged to the study patient unless the pharma company is required to pay for it by regulation. I’ve seen the budgets; you have multi-million dollar companies who will not cover any costs except the study drug itself. Almost every other disease, either most or all of the costs are covered. I always hustled to get everything covered but when I did the finances I worked in psychiatry & neurology, so it was easier for me to negotiate for all costs to be covered. Cancer treatment is ridiculously expensive & people are facing death. Also, there are certain privileges that give someone an opportunity to be a part of a study. All of the additional doctor visits means missing days of work and a whole lot more travel. The length of the visits often means you’re fasting for blood tests & then need to bring or buy lunch, etc., etc. Who can miss work?

    • Thank you for raising the awareness with this question and As a caretaker of a cancer patient and wife not to mention a caretaker of color I totally can empathize with your specific point who can take off work who can afford many of the expenses that come along with being in a clinical trial and yes there are certain advantages to being in trials and some have greater advantages although if you do not seek out the information often times certain opportunities that could make it easier for you or your family are not presented to you.
      So with going through clinical trials trying to work given through your pain and fatigue and the most important thing trying to keep and maintain your job missing these days of work because of a lengthy appointment and continuous test are of the highest most important because there is gas that you have to buy for travel there is food you have to provide for the patient and yourself

  • The problem is that it means drugs are being approved to service a population as standard of care with no evidence that the drug is effective on that population. This alone could account for higher mor morbidity among minorities, because there is no effort being made to make sure the drug as safe and as effective across all groups and no evidence that it is. The phase 1 trials with higher minority participation are usually “hail Marys” those trials typically are mainly to find out if the drug is safe to give in a broader setting with no guarantees that it will do anything for the participant. It is shameful science, and somewhat exploitative use of minorities who get further reasons to distrust the research community. That is the biggest hurdle for recruitment.

  • Also, US drug trials are sometimes conducted in Europe where they do not allow questioning of race and ethnicity, due to privacy issues. These studies are necessary to gain global approval for medications.

  • I work in pharma trials. We know this is a problem. We have tried to do things like work with the the academy of Black Cardiologists (when I did CV trials) and we try to go to diverse sites. We also, however, to keep costs down, recruit sites who enroll. If whites will enroll in trials, and sites with white patients do research, then those sites get trials. Are black and Hispanic patients going to small. local hospitals without research programs? ( maybe, since these patients do enroll in what sounds like ph I trials when they are out of options) Are they refusing trials? We don’t know, based on this study.

    • Also, US drug trials are sometimes conducted in Europe where they do not allow questioning of race and ethnicity, due to privacy issues. These studies are necessary to gain global approval for medications.

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