Misconceptions About Cancer Clinical Trials And How To Overcome Them

A conversation with Wasif Saif, MD, MBBS, medical oncologist; leader, Phase I Clinical Trials Multidisciplinary Team, and co-leader, Gastrointestinal and Neuroendocrine Oncology Multidisciplinary Team, Barbara Ann Karmanos Cancer Institute.

Patients and healthcare providers alike have reservations about clinical research. We know that. Sponsor companies see that in myriad ways, from having conversations with potential PIs to observing slow enrollment numbers. What, then, is a clinical trialist to do?

First, it’s important to get to the root of their hesitation by acknowledging their perceptions of clinical research, right or wrong. Then, it’s time to figure out how to ameliorate those concerns.

Here, Wasif Saif, MD, MBBS, discusses many of the misconceptions held by patients and clinicians and introduces ways to address them.

Clinical Leader: What are the top three (or any number) myths patients have about clinical trials?

Wasif Saif, MD, MBBS: Some common myths that patients have about clinical trials are:

• Clinical trial participants are treated like guinea pigs.
• Clinical trials are only for people with no other options.
• Clinical trial participants may receive a placebo (sugar pill) instead of actual treatment.

Are there any misconceptions specific to cancer trials?  

Common misconceptions surrounding cancer clinical trials often lead to hesitation or misunderstanding about their value and purpose. Additional misconceptions that we often hear are:

• Clinical trials are unsafe and risky.
• Clinical trials are only for new drugs.
• Health insurance won't cover clinical trial costs.
• Clinical trials are a last resort.
• Once enrolled, patients are locked into a trial.
• Clinical trials are only available at large medical centers in major cities.

Do providers hold the same misconceptions? If not, how are their misconceptions different?

Providers share some of the same misconceptions about clinical trials as the general public, but they also have distinct perspectives and concerns that influence their approach.

Shared misconceptions include fundamental misunderstandings about clinical trial participation, such as viewing clinical trials as a last resort or fearing being treated like a guinea pig. On the other hand, providers face specific concerns, such as time constraints due to busy clinical responsibilities, leaving them with limited time to discuss clinical trials with patients or to help them navigate the enrollment procedure, lack of time to self-educate themselves about ongoing clinical studies, trial complexity, fear of losing control over the patient’s care, and institutional support, especially lack of incentives in renumeration models that may further influence their reluctance or ability to engage with clinical trials and inform their patients about potential opportunities.

Why do these myths exist, and why are they perpetuated?

These myths exist due to multiple factors. Most importantly, the historical perspective of unethical medical experiments, such as the Tuskegee Syphilis Study and Nazi medical experiments, is the major underlying cause. Secondly, the uncertainty and fear of potential toxicities and unknown clinical benefits, compounded with the scarcity of information to the general public and the complexities of clinical trial design, further adds to the development of such myths. Finally, imbalanced information about potential benefits versus risks further leads to such myths.

The causes for the perpetuation of clinical trial myths include confirmation bias, as people tend to interpret information that aligns with their myths and beliefs; misinformation or conflicting information on social media and other platforms further complicate this scenario, as not everybody has medical knowledge or access to medical websites. Finally, there is distrust in institutions, whether based on personal experience or conspiracy theories.

What harm is being done in clinical research, the wider drug development industry, and even healthcare, as long as these misconceptions exist?

Misconceptions about clinical research negatively affect drug development and healthcare as a whole. Misconceptions lead to reduced inclusion of minorities, a lack of diversity in clinical trials, challenges in overall accrual to clinical trials, and delays in drug development.

In what specific ways have you worked to address and dispel these myths with both patients and providers?

I have invested in providing empathetic, comprehensive, and evidence-based communication at all levels, including outreach programs, videos, and podcasts, online and through multiple media channels (including this one!) to provide education, and above all, connecting with providers both internally and outside of the Karmanos network. We are always working to open new collaborations, we are developing educational programs for providers, we are developing physician-friendly referral programs, and supporting incentives to leadership for the physicians to complement their efforts toward clinical trials. We are also communicating patient success stories as much as we can. Externally, we are playing a significant role in building a culture of trust and open communication so providers understand clinical trials will not snatch away their patients.

What were the outcomes?

My efforts have led to improved referrals to clinical trials. We are building a village where community and academic physicians are aware of the availability of clinical trials, so we are all working for the patient to offer the best possible outcome. In part through these efforts, community physicians are increasingly realizing how clinical trials fit into the continuum of care.

What advice do you have for sponsor companies trying to educate and engage providers? How about for patients?

Sponsor companies can bridge the gap by offering providers clear, detailed trial information and by simplifying the referral SOPs (standard operating procedures).

Similarly, sponsors should do the same for patients by developing patient-friendly language, transparency about potential risks and possible benefits, and a seamless and less time-consuming, patient-centric approach that not only builds trust but is a convenient bridge to clean trials. Lastly, supportive customer service in this arena can also do amazing work.

About The Expert:

Wasif Saif, MD, MBBS, medical oncologist, is the Phase I Clinical Trials Multidisciplinary Team (MDT) leader, and the Gastrointestinal and Neuroendocrine Oncology MDT co-leader at the Barbara Ann Karmanos Cancer Institute.

Dr. Saif is an internationally renowned expert in gastrointestinal cancers, experimental therapeutics, and pharmacogenetics. He has led numerous clinical trials resulting in FDA-approved therapies for various tumor types. He has vast experience with phase I dose-defining and hypothesis-driven studies and collaborates with leading institutions like Yale, Columbia, and Cold Spring Harbor Laboratories.

His research is rooted in translational studies in GI carcinogenesis, predictive biomarkers, and mechanisms of resistance to cancer therapeutics. He has made significant contributions to research on fluoropyrimidine drugs, focusing on dihydropyrimidine dehydrogenase (DPD) deficiency, the uracil breath test, and thymidylate synthase genotyping.

He has contributed to over 600 peer-reviewed publications, is a frequent speaker at national and international conferences and serves on grant review committees worldwide.