My Blog
Patient Involvement with Research Studies
Patient Involvement in Research Studies
While clinical research in the new millennium holds great promise and tremendous opportunities, the realization of this potential is not without significant obstacles and barriers. Chief among them is patient participation. Patient In clinical research, patient participation is the critical ingredient for a successful clinical research study. But the reality is, most patients are unaware are uninformed.
In a recent poll of 6,000 cancer patients, 84% were unaware, at the time of their diagnosis, that participation in a clinical trial was an option.1 Less than 5% of those surveyed participated in trials despite the fact that most experts believe there should be at least a 10% to15% participation rate.2 In contrast, 80% to 90% of cancer-afflicted children are enrolled in clinical trials. Many believe this is a reflection of the hands-on advocacy practiced by pediatric oncology teams, and the resultant trust and confidence of parents and children in the clinical trial process.2
Physician advocacy and communication are critically important to insuring patient participation. Nearly 50% of all patients involved in trials first learn of them through their physicians. Mass media and the internet add another 35% and 9%, respectively, to that awareness; while friends and family contribute an additional 8%.
An enormous outreach is required to deliver a few active individuals willing to participate over the life of a clinical study. In the year 2000, a panel of experts determined that of the 6.5 million people asked to participate in clinical studies, only 675,000 people participated, for a response rate of approximately 10%.1 In a second study involving 1,500 initial responders to requests for participation in a clinical trial, only 320 passed the preliminary eligibility screening. Of those, ultimately 110 enrolled in the study and only 80 completed it.3
In reality, the challenges of patient recruitment delay most clinical research studies. Only 8% of all clinical trials start on or ahead of schedule. Conversely, 82% are delayed by recruitment problems. Of those, 22% are delayed by one month, 47% are delayed by one to six months, and 13% are delayed for more than six months.3 Despite these recruitment issues, 83% of the respondents into one Harris Interactive survey said that they would consider participating in a clinical research study.4
The pros and cons of participation in a clinical research study are well known to patients and physicians, alike. On the positive side, 58% chose to participate to benefit themselves or others, 48% believed participation would result in a fuller disclosure of all risks, 35% chose to enroll when it was clear that the potential benefits outweighed the reasonable risks, and 35% believed that the trial might yield a cure. Fully 35% acted based on the recommendation of their physician, while 23% saw participation as a way to advance science.3,4
On the negative side, there remains fear and caution. Fully 48% believed that they might receive a placebo rather than active treatment. Many do not understand that most studies, and certainly those dealing with serious medical conditions like cancer, test new therapies against standard therapies, not against placebos. Patients also fail to appreciate that the clinical researcher constantly monitors results, and that the protocol defines circumstances that lead to halting a study, or removing a patient from the study, if safety becomes an issue. Nonetheless, safety is an issue for patients, with 39%citing fear of bad side effects as a reason not to participate. Finally 29% were concerned that, once the study was completed, they would lose access to a treatment that was working, and be back where they started.
The good news is that, in spite of these concerns, when patients participate, they respond favorably to the experience. In one large study, 93% agreed that the research team acted professionally; 97% said they'd experienced a thorough discussion of risks and benefits, and felt they were fully informed; and 91% felt the quality of care was as good as, or better than, that provided by their regular doctor.
Partnering with a clinical research team is not easy. It demands time, energy, and focus for the patient and his or her family. It means being engaged and alert, and sometimes re-asking questions and confronting the unknown. But the record shows that when patients get involved, science succeeds and we all benefit.
Until next time, for Health Politics, I'm Dr. Mike Magee.
References
October 15, 2003
