When faced with treatment decisions, it is not uncommon for patients to ask “What do you think I should do?”. This is only natural – when faced with making a difficult decision, it makes sense to ask for expert advice. And as a health professional who wants what’s best for your patients, it is very tempting to say “I think you should do ….”. Health Professionals can give expert information but should never presume to know what is best for a patient. This ethical principle is very important in clinical practice but very tightly regulated in clinical trials.
GCP states that consent to a clinical trial should be freely given. The National Statement expands on this principle and states that participation should be based on sufficient information to understand the risks and benefits of participation.
The best way to assist a patient who is having trouble making a decision is to present information on all treatment options (including the clinical trials) covering the positives and negatives in a way that the patient can understand. Study Coordinators are a great resource in the consent process. Their understanding of the research processes helps the patient understand the logistics of how the trial works at your particular site and how this is different from standard of care. Time to consider the information and encouragement to discuss treatment options with trusted family and friends are also importan.