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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.”

Clinical Trials

“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.”

Observational Studies

“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.”

Important Considerations:

  • 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.

Posted By Request:

My name is Carolina Anaya, and I am the research coordinator for the University of Chicago’s Eating Disorders Program led by Dr. Jennifer Wildes. I’m reaching out in hopes that we could advertise a study we are currently recruiting. I have attached IRB approval and the research summary. The researchers are Dr. Jennifer Wildes (University of Chicago), Dr. Sarah Keedy (University of Chicago), Dr. Scott Hunter (University of Chicago), and Dr. Christy Tangney (Rush University).

The study is being conducted to better understand relations between biological measures, cognitive function, and eating problems in adolescent girls.  The study includes interviews, questionnaires, behavioral tasks, an MRI brain scan, and a blood draw. The study will occur across at least 2 study visits at the University of Chicago in Hyde Park. Participants can receive $150 for taking part in study activities.

Individuals may be eligible to participate if they are female, between the ages of 12 and 19 years old, and currently restricting the amount of food they eat.

Closing date for recruitment is July 1st, 2019.

For more information, individuals can call (773) 834-0362 or email canaya1@bsd.uchicago.edu.

https://www.facebook.com/UofCEatingDisordersProgram/photos/a.260149514055682/2282761825127764/?type=3

Posted By Request:

UNIVERSITY OF NORTH CAROLINA AT GREENSBORO

Project Title:  Personal Perceptions about Eating Disorders and Potential Services

Please contact the researcher if you would like a printed copy of this consent form at jestreuk@uncg.edu.  If you have any questions about this study at any time, you should ask the researchers named in this consent form. Their contact information is below.

What is the study about?
This is a research project.  Your participation is voluntary. The purpose of this study is to assess perception of the underlying cause(s) for eating disorders and potential participants’ interest in genetic counseling and testing that may help determine how to best care for individuals with eating disorders.

Why are you asking me?
Individuals age 18-65 who have been personally diagnosed with an eating disorder are eligible to complete the survey. Insight from these individuals about the potential for genetic services for them may help to guide such service development in the future.

What will you ask me to do if I agree to be in the study?
The survey will assess demographics and personal opinions and perceptions about eating disorders as well as genetic services. It is anticipated to take 15-35 minutes depending upon depth of open-ended responses. There is a final question asking about interest in being contacted for future studies. Completion of this question is voluntary. Should you choose to provide contact information it will not be linked with your individual response.

If you have questions, want more information or have suggestions, please contact Julianne Streukens who may be reached at jestreuk@uncg.edu or Lauren Doyle who may be reached at ledoyle2@uncg.edu.

If you have any concerns about your rights, how you are being treated, concerns or complaints about this project or benefits or risks associated with being in this study please contact the Office of Research Integrity at UNCG toll-free at (855)-251-2351.

https://uncg.qualtrics.com/jfe/form/SV_1HylfQxwa8vRjHT?fbclid=IwAR1pBG-21rtku1RQ-C9CICd9vl2PZgNVYZhVJVUtaxqRFvqTvhwsEvXctJU