Should I Or Should I Not?: What You Need to Know About Participating in a Medical Research Study

By Sumangala Vasudevan, MD and Dace Trence, MD, FACE

It’s not uncommon to open the newspaper (or your tablet or smart phone) and read on almost a daily basis about the latest results of medical research studies known as clinical trials. Although most of us have heard of these types of studies, we typically don’t pay much attention until we have a serious illness like cancer or a vested interest in the outcome. So, what exactly is a clinical trial? It is a type of research in which people volunteer to test the safety and effectiveness of new health interventions (drugs, devices, diagnostic tests, etc.). Clinical research plays a vital role in determining if a new product or new way of treating a disease really works, often acting as a bridge for research conducted in a laboratory to then be applied to real-life clinical practice.

Knowing all you can about clinical trials in general – as well as the one(s) you are thinking about taking part in – can help you feel better about making your decision. Knowing what to look for and what to expect ahead of time also can be helpful when deciding to participate. This guide addresses many basic questions and concerns so that you will be better prepared to discuss clinical trials with your physician and your family as you make your decision.

Clinical trials are conducted by a research team that includes doctors, nurses and other health care professionals. The team is led by a principal investigator, usually a physician with special interest in the condition being studied. Investigators who design the clinical study create criteria based on factors like age, type/duration/ stage of disease, and other medical illness and treatments (current/past) to determine who can participate in the study. These criteria are used to identify appropriate participants who are safe to undergo the study. Criteria which allow someone to participate in the trial are called inclusion criteria and those that disqualify participation are called exclusion criteria.

Prior to participating in a clinical trial, informed consent has to be obtained from the participant. Informed consent is a process during which researchers provide participants with information regarding the risks, benefits and alternatives of the study. It is extremely important for you to understand the benefits and risks of your involvement. All studies are designed to answer a question. It might be whether a new drug is better than currently available drugs. It might be whether a new procedure is better than a currently used procedure. This should be clearly stated in the information you are given at the very first meeting you have with the research team member(s). Participants also may receive study information material to help enhance understanding of the study objectives and protocol. Understanding what the research will be about should be your first step.

If a participant satisfies the study criteria and agrees to take part in the trial, an informed consent document has to be signed. Informed consent is not a contract, and the participant has the right to withdraw from the study at any time. Make sure that if anything is unclear in the consent form or if there is something that has not been discussed, ask about it! Some consent forms might have several parts, each requiring a separate agreement. You should never feel rushed into signing a consent form. Take the form home with you and read it completely, before signing, if you need more time to review the information. You should expect to be given a copy of the consent form you have signed to refer to and for your personal records. The consent also should provide contact information about the study investigators, coordinators and emergency contact.

An important question to ask is whether a continued supply of the study drug or device at the end of the trial might be available. Some sponsors continue to provide the study treatment, whereas others do not. Discussion with the study investigator during informed consent provides an opportunity for the participant to raise these and other concerns they may have. Participants can chose to have their significant family members or friends present at the time of discussion with the study investigator.

Participants should also read the confidentiality and privacy form designed for the trial before consenting to participate. Individual participants’ names and identifying information are not part of the data reporting – participants are typically given coded number or letter combinations that are used for data reports. The consent form should state how and with whom the scientific information will be shared.

In clinical trials, one group of patients receives the trial medication and another group (control group) is given the standard medication or placebo, which may be an inactive pill, liquid or powder. You might not know which group you might be assigned to until a certain stage of the study. Though clinical investigators would provide care for the condition being studied, they do not provide healthcare for other medical conditions or illnesses. Hence, it is advisable to involve a primary care provider at the time of enrollment in a study. The primary care provider can also ensure that the study protocol will not conflict with the participant’s current medical treatment.

It is important to understand that any study treatment might not be effective and there can be side-effects... even life-threatening side effects can occur, although it’s very rare. Possible side effects should be clearly reviewed and discussed with you. Also, ask the research team about the expected visit numbers and a visit schedule; you might need to be seen frequently and may need specific tests at specific times, which would mean planning your personal schedule for weeks, months, or even longer to be available for tests. You will need to plan ahead for time constraints between research, home and job circumstances.

Most studies offer advantages in the form of physical exams and laboratory testing that are free to each participant. Participation can provide access to expert medical care and new treatments not yet available to the public. Many trials also offer compensation in form of financial reimbursement. This can range from parking fee coverage to meals, even to compensation for the time you might need to spend in a study and its requirements, such as keeping specific daily records or taking specific tests.

Clinical trials are usually funded by pharmaceutical companies or federal agencies like the National Institutes of Health (NIH). Sometimes, voluntary groups or medical institutions can also fund and sponsor the clinical trial. Clinical trials might take place in various locations such as hospitals or medical offices. They can take place at one center or multiple centers across the country or even multiple centers across the world.

Every clinical trial has to be approved, monitored and reviewed by an Institutional Review Board (IRB) made up of physicians, researchers and community advocates. Its role is to ensure that federal and state laws are followed and patient rights and safety are protected. Food and Drug Administration (FDA) regulations have empowered IRBs to approve, modify or disapprove research. Apart from the IRB, some clinical trials have a data monitoring committee, an independent group of experts who monitor patient safety and treatment efficacy while the trial is ongoing. While not a part of the study, this group follows the accumulating data to make sure that the study continues to be safe for study participants.

There’s no right or wrong choice when making the decision about taking part in a clinical trial – it all comes down to your own priorities, values and preferences. But if you do choose to participate, you can take pride in the knowledge that any others benefitted from your willingness to get involved.

Are you curious about studies available in your area? Information on clinical trials currently being conducted can be found at, an interactive online database managed by the National Library of Medicine.

Sumangala Vasudevan, MD, is a board-certified internist at Providence Medical Group, Everett, Washington. She attended medical school in India and finished her residency at John H. Stroger Hospital of Cook County in Chicago. Her special interest is in diabetes management and diabetes research. She plays an active role in diabetes education and its complications for her patients and plans to enter a fellowship in endocrinology in 2015.

Dr. Dace Trence is Director of the Diabetes Care Center and Professor of Medicine at the University of Washington Medical Center in Seattle. She is also the University of Washington Endocrine Fellowship Program Director and Director of Endocrine Days, a medical education program for endocrinologists practicing in the Pacific Northwest. She is on the American College of Endocrinology Board of Trustees and chairs the CME Committee and is also chair of the AACE Publications Committee.