Pancreatic Cancer Trials Wasted by Racial Inequalities
Clinical trials assess the efficacy and safety of cancer medications and help set the standard of care. As such, unequal representation of certain races leaves gaps in knowledge, limits prospects to investigative therapeutics, and, later on, facilitates disparities in survivorship.
According to results announced at the 14th virtual AACR Conference on the Science of Cancer Health Disparities in Ethnic/Racial Minorities and the Medically Underserved, which was held on October 6, 2021, a simulated pancreatic cancer clinical trial showed that black people were significantly more likely to be excluded from clinical trials compared to white people.
In the past, research has shown that ethnic and racial minorities are significantly underrepresented in clinical trials. This is quite dangerous because clinical trials are the basis of FDA approval for any drug in the US (Food and Drug Administration).
What Have Doctors Said About This Issue?
Clinical trials that do not include people from all races and genders may present an incomplete or inaccurate picture of how various drugs affect different populations, as explained by the study’s lead researcher, Dr. Andrea N. Riner, a general surgery resident and research fellow at the University of Florida in Gainesville.
Dr. Riner says, “Biased representation of applicants leaves gaps in our data, limits chances of getting trial therapeutics, and propagates inequalities in survivorship.”
Riner says this study can be used to change the existing clinical trial enrollment exercise. Given the range of drugs being tested, changes should be implemented on a trial-by-trial basis.”
Since chemotherapy trials require different criteria to immunotherapy trials because of how the meds work, Dr. Riner says, “These decisions should be made collaboratively by the clinical trial sponsor and an advisory board of medical practitioners who can determine which criteria are necessary.”
Riner added that “Alternative eligibility criteria can enhance the diversity of applicants, offer more impartial access to investigational therapeutics and cut inequalities in survivorship without compromising on applicant safety or research results.”
What Was the Eligibility Criteria for The Study?
Clinical trial eligibility standards have been suggested to variably impact specific ethnic/racial groups who have a higher chance of getting chronic and infectious diseases. Therefore, the study aimed to determine the impact of the eligibility criteria on inequalities in pancreatic cancer clinical trial candidature.
This simulated clinical trial screening process used the eligibility criteria of phase 2 and 3 pancreatic cancer clinical trials listed on ClinicalTrials.gov. In addition, persons with pancreatic ductal adenocarcinoma who sought medical assistance at the VCU Massey Cancer Center in Richmond, Virginia, from 2010 to 2019 were included.
In this study under the tutelage of Dr. Jose G. Trevino, the surgeon in charge at the VCU Massey Cancer Center, Dr. Riner and physicians from the VCU examined the normally utilized standards to decide who qualifies for a pancreatic cancer clinical trial.
Dr. Riner explained that many pancreatic cancer clinical trials employ these standards because they have been in place for a long while. However, due to a couple of reasons, she says, “These standards might not be medically acceptable.”
Dr. Riner and her colleagues simulated a screening process for a pancreatic cancer clinical trial using data from patients with pancreatic ductal adenocarcinoma who sought medical care at the VCU Massey Cancer Center from 2010 to 2019.
Riner and her team compiled common eligibility standards for phase 2 and phase 3 pancreatic cancer trials as per clinicaltrials.gov. They demonstrated inclusion and exclusion based on clinical data obtained from medical records and billing codes.
The criteria that most frequently excluded black participants were related to nutritional and infectious disease markers. They included:
- Albumin is a nutritional marker. 14.07% of black participants were left out of this criterion, compared to just 7.91% of white participants.
- Hepatitis B – 1.742% of black participants were excluded from this criterion compared to 0% of white participants.
- Hepatitis C – In this criterion, 9.06% of black participants were left out compared to 3.43% of white participants.
- HIV – In this criterion, 3.136% of black participants were left out compared to a meager 0.286% of white participants.
A couple of other standards also inexplicably left out black participants, but the results were not of sufficient numeric importance to be noted.
The only standard in this study that left out more white participants than black ones was a history of poor cancer management. 14% of white participants were left out of this standard compared to 9.06% of black participants. This variation shows that more white people receive the required therapy for pancreatic cancer compared to black people.
Dr. Riner said when she and her colleagues left out certain standards that they felt were not vital in ensuring patient well-being or safety, the difference in eligibility was diminished. “The results of our research confirmed our fears that typical criteria lead to significantly fewer black people being eligible for pancreatic cancer clinical trials compared to white people.”
She continues, “We are creating prejudice in who may even be eligible to participate in these clinical trials, and we are at times doing so without an actual valid medical reason.”
One limitation of the study was that it was based on data from one institution center, the VCU Massey Cancer Center in Richmond, Virginia. This means that the results may not represent the entire country.
Also, based on the demographics of the study participants, Riner and her team were only able to compare qualifications between participants who identified as either black or white. Riner says that her team suspects their findings may apply to other minority groups in the US. However, more research would be needed to confirm their suspicions.
Final Thought
The eligibility criteria used in pancreatic cancer trials excluded black people from participating in these trials.
These standards prolong racial inequalities, restrict generalizability to real-world clinical instances, and are often not medically acceptable. New and improved eligibility standards can boost the representation of people from various races and reduce survivorship inequalities without compromising study results or participant safety.
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