Trials and Misconceptions
Myths and half-truths about clinical studies are pervasive and entrenched. That may account for why so few participate, even though trials lead to dramatic advances in patient care. Stephen W. Lim, MD, chair of the Institutional Review Board overseeing human subject research at Cedars-Sinai, debunks the most common misconceptions.
1. Clinical trials are risky.
While it is true that some clinical research carries risks, institutional review boards (IRBs) — the ethical oversight committees that review such research — ensure that risks to participants are minimized and that safety is monitored throughout. “The IRB must find a favorable benefit/risk ratio before approving any clinical trial,” explains Dr. Lim. “A description of all foreseeable risks must also be included in the informed consent form that each participant signs. If new risks come up during the study, volunteers are alerted and can withdraw.” Although Phase I trials usually test investigational therapies for toxicity, many clinical studies are merely observational or pose very low risk. “One thing is certain,” says Dr. Lim. “The welfare and rights of participants are always more important than the study’s success.”
2. Informed consent primarily protects the legal interests of researchers.
Informed consent is how researchers provide information to potential participants and those already enrolled. “The process is there to protect them,” says Dr. Lim, “and should provide enough information to explain the risks, potential benefits, and alternatives to the study. It is by no means a partial or biased document or a contract.” Participants may withdraw at any time, even if the study is still in progress, and be treated without ramifications.
3. My privacy will not be protected.
“Researchers go to great lengths to protect the privacy of research subjects,” says Dr. Lim. “The confidentiality of medical information is protected under federal regulations,” such as the Health Insurance Portability and Accountability Act (HIPAA). Data is generally coded with a unique identification number and not directly associated with the participant’s name.
4. Plenty of volunteers have signed up. I don’t need to participate.
“One reason drug development takes so long is that enrollment in clinical trials is much lower and slower than ideal,” says Dr. Lim. According to the National Cancer Institute, only about 3 percent of cancer patients enroll in clinical trials, although a much larger number are eligible. Approximately 40 percent of cancer trials cannot enroll enough patients. “It’s a huge problem,” he says. “We’ve gained unprecedented knowledge about numerous diseases, and we’re on the cusp of finding cures for many of them, but low trial enrollment really hampers our progress.”
5. If a clinical trial could help me, my doctor will tell me about it.
Cedars-Sinai is a hub for biomedical research, with one of the largest state-of-the-art clinical research trial facilities of any private hospital — attracting exceptional physician-scientists who wish to both conduct research and treat patients. “Because so many of our clinicians lead active studies,” says Dr. Lim, “patients are likely to be made aware of clinical trial options. However, this is not the case everywhere.” To find an ongoing or upcoming clinical trial at Cedars-Sinai, or for answers to frequently asked questions, visit cedars-sinai.edu and click on “search clinical trials,” or visit clinicaltrials.gov, a national resource for such studies.
6. Clinical trials are a last resort when all other treatments have failed.
This is not necessarily so, says Stephen W. Lim, MD, chair of the Institutional Review Board overseeing human subject research at Cedars-Sinai. “In many cases, clinical trials are designed to evaluate an intervention in newly diagnosed patients, or in patients who have never received treatment for their condition.” Some clinical trials evaluate new drugs that are similar to already approved and widely used medications.
7. If you enroll in a clinical trial, you may receive a placebo and get no treatment at all.
“Use of a placebo has to be scientifically and ethically justified and considered during IRB review,” explains Dr. Lim. If receiving a placebo is an option, you will be told before enrolling and the possibility will be described in the informed consent form. “Many trials do include a control factor to facilitate comparison with the treatment being studied, but in most cases that control factor involves the administration of a commonly used, FDA-approved therapy, not a placebo.”
8. Health insurance will not cover the costs of a clinical trial.
“The consent form explicitly outlines which items/services will be billed to your insurance and which will be covered by the study,” says Dr. Lim. Certain commercial health insurers are required to cover routine services in a cancer clinical trial under California law and in any clinical trial under the Affordable Care Act. And the Medicare Clinical Trial Policy explicitly covers routine services, as well as monitoring procedures, for Medicare beneficiaries in a qualifying clinical trial.
9. Clinical trials are funded by pharmaceutical or biotech companies who control the process, creating a conflict of interest.
The majority of research studies conducted at Cedars-Sinai are not funded by pharmaceutical or biotech companies, notes Dr. Lim. “Many studies are designed by Cedars-Sinai physicians and investigators. They can be supported by government or nonprofit grants, philanthropic donations, or internal funds.” Further, Cedars-Sinai has a committee to review and ensure proper management of potential conflicts of interest and disclosure in the informed consent form.