Previously I discussed the advantages of participating in a clinical trial however it is also important to educate the public on all aspects of clinical trials, including both the potential drawbacks. Here are seven key bullet points on the disadvantages of participating in a clinical trial:
Time commitment
Clinical trials often require a significant amount of time and effort from patients. I always tell patients the limiting factors for participating in a trial are cost, time, and geography. Clinical trials are very involved and may require frequent clinic visits or blood draws. Or perhaps a standard of care treatment may only take an hour to infuse but the experimental treatment requires pharmacokinetic blood testing which to the patient means frequent hourly lab draws for the rest of the day! Phase 1/2 trials may even require daily clinic visits for the first 1-2 cycles of treatments.
Barriers for trial participation
Geographical location of a trial is very important. Perhaps there may be a great trial for the patient to participate in. However, the study is all the way in Seattle and it is highly unlikely a patient from Miami may be able to enroll or maintain frequent visits. Cost is also very important to discuss. Many patients are limited in where they can have their care. An institution can be just down the road or an hour away, however insurance companies will not allow the patient to be seen there or patients may have a high out-of-pocket copays/deductible.
Unknown risks
Although clinical trials are designed to be safe, there is always a possibility of unknown side effects or other negative outcomes. Phase 1 are protocols with first in human testing. The goals of this type of study are to find the safest dose to give patients and it is a secondary (not the primary) goal to see if the treatment may control their disease. Phase 2 trials are designed to enroll a specific group of patients and determine if there is a significant response and reasonable safety to move on to a larger study in that group of patients. Phase 3 trials are typically randomized studies using an experimental therapy with or without standard of treatment to the standard arm of just usual care or even a placebo. Participants in clinical trials may need to stop receiving their regular treatments and medications, which can be unsettling and stressful. Participants in a clinical trial may also not have control over the treatment they receive, as the trial may dictate specific treatments and procedures.
No guarantee of success
Clinical trials are designed to test new treatments and there is no guarantee that the treatment being tested will be effective. Hypothetically, clinicians hope the newer therapies will work but unfortunately for most trials, this is not the case. This is the sad reality of clinical trials in metastatic pancreas cancer where only a small percentage of many early phase studies move on to larger trial and FDA approval for commercial use.
Emotional toll
The uncertainty and stress of participating in a clinical trial can take an emotional toll on patients and their families. It is already daunting to deal with a metastatic cancer diagnosis and more so with the commitment of maintaining all aspects of the trials with labs, clinic, imaging, treatments, etc. If there are unexpected side effects, this can lead to additional clinic visits or hospital admission. Clinical trials may require changes to a person’s schedule or lifestyle, which can be disruptive and difficult to manage.
Cost
Although many of the costs of a clinical trial are covered, there may still be some out-of-pocket expenses for participants including the standard of care treatment, normal standard of care visits, labs, and imaging. Clinical trials may be conducted at specialized facilities, requiring participants to travel long distances for appointments and tests. Some trials do not provide reimbursements for travel or limit reimbursements to out of city travel cost.
Limited options
Clinical trials typically test a specific treatment, which may not be the best option for every patient. A great example of this is happening in metastatic melanoma where intratumoral or cellular therapy is already demonstrating significant durable responses however while the trial data is awaiting FDA review/approval or perhaps available on compassionate programs, future patients will have to consider less tested clinical trials options. Additionally, each clinical trial is open at select institutions across the country and/or internationally. Each institution may have a completely different portfolio of trials for each tumor type and for each setting (adjuvant, 1st line, 2nd line or refractory setting).
Despite the drawbacks, participating in a clinical trial can be a rewarding and meaningful experience for patients and their families. By participating, patients can play an active role in advancing medical research and potentially benefit from cutting-edge treatments. Clinical trials offer the opportunity for access to new and innovative treatments that may not be available otherwise and provide a chance to receive specialized care from top medical professionals.
Participants also have the potential to contribute to the development of treatments that can improve outcomes for future patients with similar conditions. Additionally, participating in a clinical trial can help to expand the understanding of cancer and its treatments, and provide hope for a cure. Remember, the advantages of participating in a clinical trial far outweigh the negatives and patients can make a positive impact in the fight against cancer by participating.
About the author
Dr. Sajeve Thomas is a distinguished medical professional and a compassionate guide in the field of oncology. With over a decade of dedicated experience as a board-certified medical oncologist/internal medicine specialist, Dr. Thomas has become a trusted expert in the treatment of melanoma, sarcoma, and gastrointestinal conditions. Currently practicing at the renowned Orlando Health Cancer Institute, he brings a wealth of expertise to the complex and challenging world of oncology.