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As history shows, it is almost a guarantee that each one of us will be touched by a chronic disease, if not ourselves, then a family member or friend. Clinical trials are the gold standard for testing promising new strategies for preventing, diagnosing, and treating such ailments. For example, the cancer drugs used over the past five years were tested in clinical trials conducted five to ten years ago and, based on those studies, these new drugs are expected to improve future survival rates.
Yet, according to the National Cancer Institute, only 3 percent of adult cancer patients participate in clinical trials. People who are older, women and members of minority communities are even less likely to participate. This is quite a contrast with the 60 percent of children with cancer who participate in clinical trials. This contrast is widely recognized as a central factor in contributing to the dramatic increase in cancer survival rates among children.
Among minority populations, there have been tragic historical events that can readily explain the African American community’s reluctance to engage in clinical trials research. While this reluctance is not limited to the African American community, the widespread concerns about involvement in research may originate here: if one group’s rights can be compromised in the scientific arena, can anyone really feel truly protected?
Fortunately, while fear-based reluctance to engage in research is genuine and factually based, many protections have been put into place and are rigorously monitored to significantly reduce the risk that such abuses will occur in the future. In science today, all the players are known and must register their research plans for prior approval, and deviations from the highest ethical standards can wipe a scientist’s rights to conduct future research. This is a protection that is not obvious to the public and a consideration that needs to be better disseminated.
The National Institutes of Health maintains a database of clinical trials taking place throughout the world. As listed on this website, there are 59,078 clinical trials registered in the United States. Of these, more than 15,000 past, current, and future studies are listed for California.
In San Diego, clinical trials are taking place at prominent health facilities including University of California, San Diego; Rady’s Children’s Hospital; the Naval Medical Center; Scripps Clinic; Sharp HealthCare; and Kaiser Permanente. Given the large number of biotechnology companies that are based in San Diego and the many drugs that are developed here, San Diego healthcare facilities are a preferred partner in the rigorous testing of new strategies for disease management.
The rich racial and ethnic diversity of the San Diego community also makes it possible to attract patients with diverse backgrounds to research studies. This makes San Diego an even more important contributor to clinical trials because if a drug is not tested among people with diverse characteristics, then the drug cannot be used with confidence with the population at-large.
Nearly all researchers will report that the slow recruitment of participants to clinical trials is one of the greatest barriers to achieving rapid testing of promising new medical discoveries. Many factors contribute to the painstakingly slow process of attracting the public to consider participating in clinical research studies. Lack of awareness of the critical role that clinical trials play, limited access to critical knowledge about clinical trials, or lack of understanding about rights, safety and benefits are among the most common reasons for this low participation.
With over 80 percent of cancer patients unsure or unaware of clinical trial possibilities, physicians and nurses can play a pivotal role in identifying opportunities and informing their patients about the availability of appropriate studies. However, this is a time-consuming process that too often is rewarded with disinterest on the patient’s side. This becomes a disincentive to engaging in clinical trials discussions with future patients.
Patients can give clinicians indications of their willingness to consider clinical trials participation by proactively seeking information about clinical trials and raising the topic with their clinicians. The first step is to gain a solid working knowledge about why and how clinical trials are conducted. While there exists a wealth of information about clinical trials on the National Institutes of Health and Food and Drug Administration websites, sifting through this information can sometimes be overwhelming.
Henrietta Lacks, around whom Rebecca Skloot’s book “The Immortal Life of Henrietta Lacks” is based, was suffering from cervical cancer. If she were alive today and aware of the possibility of clinical trials participation, what questions would she ask to make an informed decision? We attempt to address these questions here.
“Why should I even weigh the pros and cons of participating in a clinical trial?”
Without availability of patients to participate in clinical trials, knowing if a drug works might not be possible, or there will be long delays in identifying beneficial drugs. Participation in clinical trials is therefore essential. Many beneficial drugs identified through such studies have resulted in improved survival rates, especially in children. Over a twenty-year period, five-year cancer survival rates have increased by more than 20 percent in children.
“How do I find a clinical trial for my condition?”
Physicians can be a great resource to begin your search for clinical trials information in general and to begin your search for researchers with clinical trials who need participants who fit a specific set of socio-economic and clinical eligibility criteria. Ask them to help you explore this option. Patients sometimes worry that such a request might offend or go against the wishes of their physician, but the cost of losing an alternative option to improve the world’s health hangs in the balance.
Being placed in a placebo group is a major fear for many patients, so an often asked question is, “What if I am in the placebo group? Would it not be better to avoid this and just stick with standard treatments?” A placebo group is one kind of control group. Usually patients in the control group are given the standard treatment, while those in the experimental group are given a new treatment thought to be better than existing options, but needing rigorous scientific testing to confirm that it truly is better, to determine how much better, and provide an assurance of safety. Sometimes there is no treatment that works or the patient has already tried standard therapy without success. If there are standard therapies already available, then patients in the control group will receive this treatment, but when there are no therapies available, the most appropriate alternative is the placebo. The placebo does not have negative side effects, and gives medical scientists the assurance that a new medical intervention has received the most rigorous testing possible to evaluate benefits and unanticipated negative side effects. The placebo control group helps scientists sort out the true benefit of taking an experimental drug from the placebo effects it can give patients. This, in turn, will help determine the effectiveness of the drug being tested in the clinical trial. Therefore, the placebo group is serving an extremely important purpose.
People who have not previously participated in a research study frequently wonder, “Can I back out of a clinical trial in which I am already enrolled?” Naturally, the research team hopes to make the experience of participating in a research study as safe, comfortable, pleasant, and meaningful as possible, both for the participants’ benefit and because retaining participants will help to keep the scientific evaluation process as rigorous as possible. However, a study participant can drop out of a research study at any time and for any reason. The research team will ask the reason for dropping out for two purposes. First, if the participant is having a problem that could be remedied, they would like to try to do so. Second, in the annual review of the study and in the final write-up of the outcomes of the evaluation process, scientists must report the number of participants who dropped out of the study and the reported reasons for dropping out. Thus, this information gathering is an important part of the routine and scientific review process for new medical discoveries.
Since the cost of medical care is such a burden, many people wonder, “Will participating in a clinical trial cover the cost of my medical care?” Others may worry, “Will my insurance continue to cover me if I participate in a clinical trial?” While most insurance companies cover participation in clinical trials, this will vary from patient to patient. It is best to discuss this important consideration with the insurance company and organization conducting the study, prior to enrollment in a trial.
There are several groups involved in clinical trials: physicians, scientists, drug companies, and participants. Drug companies, physicians, and the scientific community must provide the right tools for individuals to make informed decisions. Each individual must then be proactive to decide if participation is right for him or her by asking some important questions. While there are many issues associated with clinical trials participation, it is important to remember how past participants’ involvement in clinical trials helped to identify new medical advances that are currently being used, and to realize that participating in clinical trials today can help improve survival and quality of life for future generations.
Watch a video of Georgia Robins Sadler on this issue below:
The Reuben H. Fleet Science Center and the San Diego Center for Ethics in Science and Technology will be hosting a free public forum on Dec. 7 at 5:30 p.m. to further discuss the ethical issues surrounding clinical trial recruitment. This is the third of a nine program series that will focus on the book “The Immortal Life of Henrietta Lacks.” Come join the conversation and share your perspective with leaders in the field.
Alka Malhotra, PhD is a genetic epidemiologist and writes as a member of the San Diego Center for Ethics in Science and Technology.
Georgia Robins Sadler, BSN, MBA, PhD, is the Associate Director for Community Outreach at the Moores UCSD Cancer Center and a clinical professor in the UCSD Department of Surgery.