THE CONSENT PROCESS IN CLINICAL TRIALS
Until recently, the prognosis for patients diagnosed with metastatic malignant melanoma was poor. Standard of care chemotherapy generated very poor response rates of approximately 10-15% of patients and average survival was estimated at 6-9 months. Patients therefore relied heavily on clinical trials for better treatment options. In 2012, new targeted therapies like BRAF inhibitor (Zelboraf™) and immunotherapy (Yervoy™) received Health Canada approval as they had shown dramatic efficacy over historical chemotherapy. Since 2012, two more targeted therapies (Mekinist and Tafinlar) made it through the regulatory approval process and provincial funding reviews, providing additional options for melanoma patients in most provinces, and a number of other therapies and combination therapies are in clinical trial or under review. Since these drugs are relatively new, there remains many unanswered questions about true response rates, overall survival, and long-term side effects. There are a number of new therapies in clinical trial which are hoped to provide even better results for patients shortly.
To many patients, signing a consent form is just something one does prior to receiving treatment in a health care facility. How many patients actually read it completely from beginning to end or really understand what they have just read? Many patients place confidence in their health care team to act in their best interests and they assume that if they are being presented with an option, it must be a good one, if not the best one? Generally this is considered true, however in clinical trials there is more uncertainty than one would like to think. The clinical trial consent process remains a topic of interest as new treatments quickly become approved for cancers such as melanoma, because not so long ago there really was little effective treatment available. Now, with this new found hope for melanoma patients, clinical trials with new drugs and combinations of drugs are often the new accepted standard ‘treatment.’ Patients need to be aware of the nature of these research studies and the real possibility they will not receive maximum benefit should they be randomized to a potentially less effective ‘treatment’ or treatment arm.
It is very important when considering participating in a clinical trial that the informed consent document is read and the information is taken into serious consideration.
Things to consider from a patient perspective:
- How is the clinical trial designed? Will the drug be randomized? If so, what are my chances of getting which treatment? If randomized, will I know what treatment I will be getting?
- How is the drug administered, orally, or IV? If IV, could a central line be required for access?
- What is the time commitment? How many trips to the hospital are expected? Once at the hospital, how long is the anticipated stay?
- What are the expected side effects and ultimately, health risks?
- Is there extra testing required? e.g., blood tests, biopsies or extra procedures for study?
- Who is the contact person if difficulties are encountered when not at the hospital?
Patients should be encouraged to take the consent document home to read and discuss with those closest to them, make notes, and write down questions to bring back to the study team. It is very important patients are comfortable with their choice to participate, not only in a clinical trial, but in any treatment option. It is also essential for patients to know the consent process is just that, a process. Once consent has been provided and the document signed, the process does not end. As patients progress through treatment while on a clinical trial they should remain informed. If new information arises in regard to safety, or anything that may affect a patient’s choice to continue treatment, he or she should be informed through the study team and asked to agree or ‘re-consent’ to the new information provided.
The consent process should never be a scary process lost in medical jargon. The study team’s job is to ensure participant’s concerns are heard and questions are answered to the best of their ability while acknowledging the voluntary nature of clinical trials.
– Content provided by Tracey Moffat, Clinical Trials Nurse Princess Margaret Hospital
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For information on how to access a clinical trial in Canada Click Here
