RESEARCH FAQS

Our research team has answered some of the most common questions we receive about our clinical trials in the below FAQ. If you have any other questions not answered below, please feel free to give us a call at 617.502.1707 or email us at info@crine.org.

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 the opportunity to gain access to new 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 may not be available yet
  • improve the science and help researchers better understand how to treat diseases
  • work closely with a team of medical professionals who will closely monitor their health during the study and communicate regularly with their 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 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, hepatitis C, and other infectious diseases.

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


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. Amy E. Colson
Where does CRI conduct its research?

CRI is an independent, community-based research organization. Our research is conducted at our office in 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 as well as other related infectious diseases. For a complete listing of our current trials, click here.
Who funds 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 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). Study sponsors are always listed in the clinical trial Web summary.

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. 
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 617.502.1707, or email a team member with any questions.