Clinical Trial FAQs

FAQs about Clinical Research Trials

What is a clinical trial?
Why are clinical research trials so important?
Why should I participate in clinical research?
Who participates in clinical research studies?
Why should minorities and women participate in clinical research?
If I am enrolled in a clinical trial, how are my rights protected? Will I be safe?
What is informed consent? Why is it important?
How can I learn more about clinical trials?

FAQs about CRI’s Clinical Research Trials

Who does the clinical research at CRI?
Where does CRI conduct its research?
What kinds of clinical trials does CRI conduct?
Who pays for clinical research trials at CRI?
Why does CRI design some of its own trials?
What trials are currently available?
How can I learn more about CRI’s clinical trials?


What is a clinical trial?

“Clinical trial” is the scientific term for a test or study of a drug or medical device in order to see if it is safe and effective for people to use.


Why are clinical research trials so important?

Clinical research trials are the fastest and most effective way of finding what strategies work best to help participants live more productive, comfortable, and healthy lives. Clinical research trials also offer participants opportunities the opportunity to gain access to new, sometimes lifesaving, treatments before they would otherwise be available.


Why should I participate in clinical research?

People participate in clinical trials for many different reasons. Some of those reasons include wanting to:

  • gain access to new drugs or treatments that are not generally available yet.
  • improve the science and help researchers better understand how to treat diseases like HIV/AIDS and hepatitis C.
  • work closely with a team of medical professionals who will closely monitor their health for the duration of the study and communicate regularly with a participant’s primary care provider.


Who participates in clinical research studies?

A major goal of clinical research trials is to study a drug or treatment in order to predict how it will affect the larger group of people who will be taking the drug(s) once approved. Because treatments may work differently in different groups of people, it is important to ensure the study population mirrors, as much as possible, the diverse range of people who will eventually be taking the new drug. For all these reasons, CRI seeks to ensure diverse clinical trial enrollment to present the most realistic study populations of people with HIV and hepatitis C.


Why should minorities and women participate in clinical research?

In the past, many drugs and treatments were often tested only in Caucasian males. However, since medications can work differently in different kinds of people, it is important to consider the safety and effectiveness of treatments in ALL kinds of people. The greater the diversity of participants in a clinical trial, the better scientists understand how to help different kinds of patients.


If I am enrolled in a clinical trial, how are my rights protected? Will I be safe?

At CRI, the health of participants in clinical trials is closely tracked by expert HIV and hepatitis C physicians and study coordinators.
There are many safeguards in place to protect the rights and safety of those who volunteer for a clinical trial. These protections include:

  • The informed consent process. Potential participants review and sign a document that describes all the possible risks and benefits involved in the study (see additional information below).
  • The IRB. Every step of the research process is carefully reviewed and must be approved by an independent ethics board (known as the Institutional Review Board, or IRB) charged with protecting human participants.
  • Data Safety Monitoring Boards. Experts on the Data Safety Monitoring Board review study data as it is produced. If the data indicates any risk to participants—or any strong advantage—on a particular treatment arm, they respond as necessary. For example, if the committee sees a treatment is harmful, they will stop the study immediately.
  • FDA inspections. The FDA, the federal agency in charge of clinical research, will inspect records and research sites periodically to make sure volunteers are protected and studies are being conducted properly.


What is informed consent? Why is it important?

Before participating in a clinical trial, a member of the research team will carefully explain every aspect of the trial, including its purpose, duration, requirements, risks, and benefits. Following this explanation, you will be asked if you have any questions and given an informed consent document to sign. It is important that you understand and are comfortable with all the information in the informed consent document. You should feel free to ask as many questions as you want before signing. This document is not a contract; even after you sign, you are free to withdraw from the study at any time without facing penalties.


How can I learn more about clinical trials?

Clinicaltrials.gov:  http://clinicaltrials.gov/ct2/info/understand
The Body: http://www.thebody.com/index/treat/clintri.html
NYU Medical Center: http://www.hivinfosource.org/hivis/hivbasics/clinicaltrialbasics/index.html


Who does the clinical research at CRI?

Committed to providing access to groundbreaking HIV and hepatitis C research, the CRI research team is led by Dr. Hannah Bouldin Olivet and Dr. Amy E. Colson.

Amy E. Colson, MD, MPH, is CRI’s Research Director and Principal Investigator of Hepatitis C Studies. A graduate of Harvard-Radcliff College, Harvard Medical School, and Harvard School of Public Health, Dr. Colson has been honored for both her clinical and research practices. She received the Edward H. Kass Award in Clinical Excellence from the Massachusetts Infectious Disease Society in 1998, and she has presented her research findings at international conferences and in notable peer-reviewed journals. In addition to her work at CRI, Dr. Colson is an Infectious Disease Consultant, specializing in HIV and hepatitis C (HCV) care, for Cambridge Health Alliance. Her clinical practice is based at Cambridge Hospital’s Zinberg Clinic, and she has strong professional ties to the Brazilian community in Somerville.

Hannah Bouldin Olivet, MD, Associate Research Director and Principal Investigator of HIV Studies at CRI. She earned an AB from Harvard College, an MA from the University of Essex, U.K., and an MD from the University of New Mexico. During her residency at Cambridge Hospital, Dr. Olivet helped to lead an initiative between Cambridge Health Alliance and the public health system in Port Elizabeth, South Africa to develop an HIV curriculum to educate patients about HIV risks, transmission, and treatment. She continues to be interested in access to HIV antiretroviral treatment options in both local and international settings. Dr. Olivet is also an Internist at Cambridge Family Health, a Staff Physician at Cambridge Hospital, and a Clinical Instructor at Harvard Medical School.

CRI’s team of dedicated clinical nursing specialists, who are committed to personal, community-based participant care, is led by Julia Green, BSN, ACRN, CCRP.


Where does CRI conduct its research?

CRI is an independent, community-based research organization. Our research is conducted at our office in downtown Boston.


What kinds of clinical trials does CRI conduct?

CRI conducts a wide variety of clinical trials that focus on HIV and hepatitis C treatment. For a complete listing of our current trials, click here.


Who pays for clinical research trials at CRI?

Pharmaceutical companies pay a portion of the costs of running some clinical research trials. CRI also designs and conducts its own HIV/AIDS and hepatitis C clinical trials (called investigator-initiated or physician-led trials) for which the organization raises its own funds from foundations and private donors. In addition, CRI participates in studies funded by government organizations, such as the National Institutes of Health (NIH).
 

Why does CRI design some of its own trials?

Often these CRI investigator-initiated clinical research trials are designed to specifically answer questions in response to CRI’s own participants’ needs—with potential benefits to other HIV-positive people around the world—and are not otherwise being answered in other studies. For example, CRI’s innovative investigator-initiated study of short cycle treatment interruptions, also known as FOTO (Five Days On, Two Days Off), explores participants’ ability to maintain viral suppression on certain regimens while taking short, weekend-long breaks from their medications.


What trials are currently available?

Please click here to see a full list of CRI’s open and enrolling trials.


How can I learn more about CRI’s clinical trials?

Please feel free to contact our research team at 617.502.1700 or 617.502.1707, or email a team member with any questions.