Oncology News Central (ONC)Unethical Cancer Study Designs: Why Clinical Trials Aren’t Always Best for Patients

Modern clinical trials in oncology often prioritize regulatory approval over patient-centric outcomes, leading to ethical concerns and potential detriments in patient care.

In the realm of oncology, the long-held belief that clinical trials are the optimal treatment route for cancer patients is being scrutinized. Dr. Manni Mohyuddin highlights the ethical and practical concerns surrounding current clinical trial designs, suggesting that many trials prioritize drug approval over patient welfare. This article provides specific examples within myeloma studies, revealing the systemic issues and potential harm to patients when trials do not align with the most pressing clinical questions.

Key Points:

• Clinical Trial Assumption: The notion that clinical trials represent the best treatment for cancer patients is being challenged based on ethical and practical grounds.
• Industry-Driven Incentives: Many clinical trials are primarily conducted to bring a drug to market, often compromising the study design and control arms.
• BOSTON Trial Example: The BOSTON trial compared selinexor/bortezomib/dexamethasone with bortezomib/dexamethasone, using a control arm that was already considered inferior by existing data, highlighting a low bar for control treatments.
• CASSIOPEIA Trial Example: Despite established benefits of lenalidomide post-transplant by 2012, the CASSIOPEIA trial used observation as a control, delaying beneficial treatment to patients until 2018.
• Regulatory and Ethical Oversight: Despite the presence of institutional review boards and regulatory frameworks, ethically questionable trials continue, suggesting a systemic issue.
• Current Trials: Ongoing trials, such as one sponsored by a daratumumab manufacturer, do not offer the best available treatment to control groups, potentially reducing survival outcomes.
• Racial Disparities: Recruitment efforts for African American patients in ongoing unethical trials highlight systemic issues in addressing trial design flaws rather than rectifying them.
• Clinical Practice Implications: The article calls for a re-evaluation of clinical trial designs to ensure they genuinely benefit patients rather than merely fulfilling regulatory requirements.

“We have created an elaborate bureaucracy with our modern institutional review boards and regulatory oversight. And yet, such trials continue to enroll, and our patients continue to suffer. What a travesty.”

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