Understanding Clinical Trials and Other Research Studies
“Embrace the Data” Daniel Le Grange, PhD, F.E.A.S.T. Advisor
Research and the Treatment of Eating Disorders
F.E.A.S.T. endorses Evidenced Based Treatment of Eating Disorders. This means all options for patient care must be based on verifiable data. This data primarily arises from research studies. Studies are designed to evaluate and compare the effects of different treatment approaches on health outcomes.
What Is a Clinical Study?
According to the U.S. NIH website’s National Library of Medicine, “A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies.”
“In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, for example, diet. Clinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention.”
“In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan. Participants may receive interventions, which can include medical products, such as drugs or devices, or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.”
A Randomized Clinical Trial is a research study that assigns people to one or more treatment interventions. Participants are randomly assigned to the alternative treatment interventions under investigation. Typical interventional trials for patients with eating disorders would include pharmaceuticals, behavioral and/or psychiatric treatment protocols. Participation in a clinical trial is generally free of charge.
Since health care costs are often a serious burden, enrolling in a clinical trial may be seen as a way to obtain expensive care at no cost to participants. Generally speaking, participants in a clinical trial have a desire to find an effective treatment (benefit to self) and a desire to add to the body of knowledge for others suffering from the same disease (benefit to others). It is NOT wrong if financial benefit is part of the decision to participate. HOWEVER, it is a real concern if potential financial benefits would tempt participants to falsify or conceal important medical information, or their ability and willingness to comply with the study protocol.
How are Patients Protected in a Clinical Study?
All reputable clinical studies should undergo review by an institutional review board (IRB), also known as an independent ethics committee or ethical review board. According to Wikipedia:
“An institutional review board (IRB)…is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The number one priority of IRBs is to protect human subjects from physical or psychological harm. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are “scientific,” “ethical,” and “regulatory.”
- If you are considering a randomized interventional trial, it is important to review all of the treatment arms (control and interventions) that will be offered. Patients randomized into “control” groups would not receive the experimental treatment or medications that are under investigation. Typically, control groups would receive placebo medications or other traditional modes of treatment. If this would be a concern to your family, it is important to directly communicate that information to the investigation staff during the application process.
- Patient safety requires that a complete and accurate medical history must be provided during the application process. It is essential to review the time commitment, special testing requirements, and all logistical aspects of study participation.
- When considering a pharmaceutical interventional trial, carefully review the risks and benefits of medications being tested, including potential side effects.
- After reviewing the study protocol, write down any questions you may have. You can ask for all answers to be provided in writing. Be sure you are comfortable with the protocols and objectives, care during and after study completion, the research team itself, and the setting where care will be provided. It’s important to consider how every requirement of participation will impact your family and your child, before consenting to any study.
- You may speak with one of the investigators at any time if you have concerns about the study itself or other staff members.
- We encourage all families considering this option for care to thoroughly review these questions.
- Although you may withdraw at any time, it is best not to enroll in a study if you have reservations from the onset.
F.E.A.S.T. does not endorse any particular study. Our goal is to offer caregivers and patients who may be considering this option, information that can help with this determination. We believe the decision to participate in a clinical trial is highly individual and best made between caregivers and their medical and therapeutic team.
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