Explaining Research to Patients
It is imperative that we as oncologists take the time to explain what a trial is for, why it is scientifically and ethically justified, and to assure patients that their total care is not being abandoned to a computerized, randomization process selected over the Internet.
— John F. Smyth, MD
Everyone understands the need for medical research, especially regarding cancer. However, only a minority of the public understand what is actually involved in taking part in a clinical trial. As professionals, we are responsible for designing relevant studies, for their conduct and analysis, and as part of this process, for selecting appropriate patients to whom participation may be relevant—all very obvious. However, the concept of obtaining and giving “informed consent” is worth a little reflection.
‘Informed Consent’ vs True Understanding
In the days when protocols were 4 to 6 pages long, ethics committees trusted their medical colleagues, and patients only asked the questions to which they really wanted answers—life was simple. Now the protocols are very lengthy, ethics committees expect consent forms to highlight every possible disaster that could occur, and time pressures result in potential participants being given lengthy written explanations of trials, with sometimes little time for a real explanation of what is involved. Instead, the patient is given a handout and invited to return for questions and answers—not necessarily with the same clinician—if there is anything that is not clear. Not good.
I have recent personal experience of this. A family member (an ex-nurse) was diagnosed with multiple myeloma. Despite being referred to a well-recognized cancer center, she was given little explanation of what the diagnosis actually meant, but was offered participation in a national trial. Very little information was given about the reasons for this specific trial, but she was given an 8-page document of explanations prior to potential consent. I had to read this document twice before I understood the trial, there being no fewer than three consecutive randomizations depending on progress, and very little detail of what was actually involved. She has agreed to participate, but her signature does not in truth represent “informed” consent.
The reason that we should try to explain research is that the very nature of a clinical trial introduces the concept of uncertainty. One of the most important responsibilities that we have as oncologists is to help patients with their anxiety over the uncertain future that their diagnosis implies. Now that we have treatment for most cancers that offers some measure of benefit, the issue of life expectancy is less certain than in the days when we did not have such therapies.
Without being patronizing or creating false hope, we seek to reassure patients that we know how to help them. This reassurance is inestimable to an anxious patient, but when introducing the concept of a clinical trial, we run the risk of undermining the very confidence that we wish to convey. We have to introduce the uncertainty that something new may be better—or may not. We do not know the answer or we would not be asking the question.
The way that such information is explained is key to retaining confidence for patients. It is well established that participation in clinical trials is good for patients—the additional quality assurance of adhering to trial protocols, the extra contact time with medical and nursing staff, etc. My point is simply that it is imperative that we as oncologists take the time to explain what a trial is for, why it is scientifically and ethically justified, and to assure patients that their total care is not being abandoned to a computerized, randomization process selected over the Internet.
I have found it particularly challenging to explain placebo-controlled trials to patients, where so often it has been clear that they are desperate to have the experimental drug. This can take a little longer to explain, but then it is even more important to emphasize the benefits of trial participation, the extra care involved and so forth, regardless of study arm.
Phase I Studies
To the surprise of some of my referring colleagues, I have found it easier to explain phase I trials or first-in-man studies. Patient selection is particularly important in this setting, and patients will usually have exhausted established treatments, or possibly already have taken part in trials comparing potentially therapeutic medicines. The explanation of participation in a phase I trial has to include the fact that this is potentially of very little if any clinical benefit to the individual patient.
In this setting, I have emphasized that participation can be of significant benefit to science, and for this reason alone I have found that patients are usually more than willing to take part. I emphasize that in phase I studies, patients are regarded as partners in such research. If they are well selected, they can experience genuine comfort in feeling that they are making a contribution, and not being “abandoned” by their doctors now that the active phase of treatment is over.
Handouts and written explanations have their place in this process. They ensure that details are explained, and they are a resource to return to as required. However, they are no substitute for compassionate, real-time communication with the doctor.
All this takes time—that most precious of all commodities, especially when life expectancy is short. We have to find the time to ensure that a patient’s consent is as “informed” as possible. ■
Disclosure: Dr. Smyth reported no potential conflicts of interest.
Dr. Smyth is Emeritus Professor of Medical Oncology at the University of Edinburgh, Scotland, United Kingdom.