“It has to be made unambiguously clear that what they are to receive is not clinical care,” says Paul Romain, MD, chief of rheumatology at the Cambridge Health Alliance in Cambridge, Mass. “There is a loss of the physician’s ability to make decisions that personalize the intervention. The goal of the research is to produce scientifically valid results and that means adhering to the predetermined research protocol.”
In clinical practice, prescribing a drug or suggesting a procedure is done with the assumption that it most likely will benefit the patient. This assumption is not present in clinical trials.
One of the concerns voiced in aftermath of Mohr’s death was the issue of the bond between a patient and physician and how it might influence the subject’s decision. The normal trust that a patient puts in the doctor may lead to problems with informed consent if the doctor/researcher is not very careful.
“Patients and physicians often have a disproportionate belief in the likelihood that the intervention will benefit the subject-patient,” says Dr. Romain. “Data show that subjects in a study often do not appreciate the blinded nature of whether they get placebo or active treatments. They assume the doctor is likely to do what is best for them, not fully understanding that the decisions are being made on what is best for the trial.”
This can be especially troublesome if the subjects are not fully aware of how the randomization process may affect their treatment and its impact on disease. For example, giving a placebo in a trial assessing the impact of a medication on rheumatoid arthritis could result in additional damage to the joint.
A similar concern relates to whether subjects know how their care in a trial differs from the standard of care. The trial may require multiple X-rays when usual practice only suggests one. Information on risks that are added because of the study’s requirements need to be included.
Recommended Reading for Patients
Goal Is Not Individualized Care
The goal of a trial is to produce generalizable knowledge, whereas the goal of clinical medicine is to produce individualized care. They are two very different objectives, and the differences need to be thoroughly explained as part of the informed consent process.
Size and complexity of the consent form can be another significant difference. It is not unusual to find consent forms that run to 10 or 15 pages outlining every possible concern in often legalistic language. This was brought out following Mohr’s death.
