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FAQs

Participating in a Clinical Trial

As you consider treatment options for yourself or a loved one, you may consider participating in a clinical trial. New medical techniques, drug discoveries, and device inventions are created everyday to help improve our quality of life. Participating as a study subject is a way to contribute to the advancement of medical innovation.

The information and links below will provide you with more information about clinical trials and other resources that may be available to you.

What is a clinical trial?

As defined by the International Conference on Harmonisation (ICH), a clinical trial is any investigation in human subjects intended to:

  • Discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or
  • Identify any adverse reactions to an investigational product(s), and/or
  • Study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

Why participate in a clinical trial?

People choose to participate in clinical trials for reasons as individual as they are. Clinical trials can either enhance treatment, or be a treatment option. Some people seek clinical trials when other treatment options have not been successful. 

Here are just a few of the many reasons people choose to participate in these studies:

  • Many, if not all, treatment drugs and tests are free to study participants.
  • Successful clinical trials may improve the length and quality of life for study participants.
  • Clinical trials provide an opportunity to take positive action by contributing to the understanding of a disease or condition and by furthering treatment options available to others.
  • Patients in successful clinical trials are the first to benefit from these cutting-edge treatments.

Why are clinical trials important?

Advances in medicine and science are the result of new ideas and approaches developed through research. New cancer treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made widely available. Through clinical trials, researchers learn which approaches are more effective than others and is the best way to test a new treatment.

Who sponsors clinical trials?

Clinical trials are sponsored and funded by a variety of organizations:

  • Private companies such as pharmaceutical and medical device companies.
  • National Institutes of Health (NIH) or other federal agencies such as the Department of Defense (DOD).
  • Academic medical institutions or not-for-profit organizations such as the American Heart Association (AHA).

What are the benefits, disadvantages, and risks of participating?

The benefits, disadvantages, and risks of a clinical trial are listed in the consent form which must be read and signed by each study participant before the trial occurs.

Benefits


  • During the time of participation in a clinical trial, patients may benefit from a research medication or treatment long before it is available to the general public.
  • Throughout the trial, patients receive careful medical attention.
  • There might be extra examinations and tests which will not be billed to patients or their insurance companies.
  • Some patients consider it a benefit that they are contributing to medical science.

Disadvantages


  • The main disadvantage to participating in a clinical trial is the time commitment. During the trial, additional office visits or laboratory tests are sometimes needed.  Although the patient is not required to pay for these extra services, they often can be time consuming. However inconvenient, some trials do provide payment for travel-related expenses.
  • Some clinical trials require participants to discontinue use of their regular treatment/medication before the trial begins. Depending on the treatment/medication, there is a possibility of a short time of increased discomfort until the new treatment begins to work.
  • With any treatment, there is always a possibility that the study treatment will not have any effect, or worse, a negative effect on a patient.

Risks

As with other treatments, those used in clinical trials may cause side effects that vary from person to person. Because the research treatments being tested in a clinical trial may be relatively new, it is possible that unknown side effects could occur. Before the trial begins, the risks and possible side effects specific to the clinical trial must be listed in the consent form and discussed by the research team with each participant.

Who can participate in clinical trials?

A variety of people can participate in clinical trials. Every  protocol identifies a specific set of characteristics that study subjects should have in order to participate in the study.  These characteristics are called eligibility criteria. They may include the type of disease or condition and its stage, as well as the age and general health of the participants.

Eligibility criteria are a key part of medical research:

  • They help assure that the study results answer the research question.
  • They help doctors identify who will benefit in the future from the approach being studied. For example, in cancer prevention studies, a new medication may work for people with one type of risk factor but not for those with another.
  • They help assure the safety of participants by protecting them from known risks. For instance, some medications can only be given safely if a person has normal kidneys or liver. In this situation, persons with kidney or liver problems may be excluded from participating.

What are the different types of clinical trials?

Clinical trials fall into one of four main categories:

1. Treatment Trials

Designed to test new treatments, new drugs, new medical devices, or new medical procedures.

2. Prevention Trials

Examine better or new ways to prevent disease from occurring or reoccurring. The methods being tested in the trial may involve drugs, lifestyle changes, dietary modifications, or vaccines.

3. Screening Trials

Examine methods of detecting disease or health problems

4. Quality of Life Trials

Designed to find ways to improve the quality of life and comfort level of those with chronic illnesses.

What are the different phases of clinical trials?

View the Clinical Development Cycle Chart. 

What is a clinical trial protocol?

Every clinical trial has a carefully designed plan that provides complete details on the conduct of the trial. The protocol is written by the physician or sponsor and is provided to all the physicians involved.

The purpose of the clinical trial protocol is to ensure that the study is justified, that the entire trial is safe for the participants of the study, and that the study is designed to allow the research questions to be answered.

The protocol provides details on the:

  • Justification for conducting the study.
  • Types of people needed to answer the question being studied.
  • Number of people needed to answer the question being studied.
  • Schedule of tests and procedures involved in the study.
  • Medications and/or medical devices involved.
  • Length of the study.
  • Plan for analyzing the data produced.
  • Guidelines and rules for stopping the study.

What is a placebo?

A placebo is an inactive substance, either a pill, liquid, or powder that has no bodily effect or treatment value.

A clinical trial is often designed to compare the new medication to a placebo in order to determine the effectiveness of the new medication. A study may be designed such that the participants assigned to the control group of a study receive a placebo.

What is a control group?

The control group of a clinical trial serves as a "baseline" against which the results of the experimental group can be compared.

Often times the clinical trial is designed such that the control group receives the standard treatment or a placebo, while the treatment group receives the new medicine or experimental treatment.

What is informed consent?

Informed consent is the process by which the study team explains all processes, potential risks/benefits, and the overall realm of a study to a study participant so that he/she understands and can make an appropriate decision on whether or not he/she would like to participate.

  • Informed consent is required in studies that are federally regulated or funded as well as by many state laws.
  • The informed consent process is an ongoing process. If you enter a trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.
  • Signing a consent form does not bind you to the study. You can still choose to leave the study at any time.

The study participant is given an informed consent form that lists the benefits, disadvantages, and risks of the clinical trial. This form should be read and considered carefully and any questions the participant may have should be asked and explained thoroughly. After all aspects have been considered by the participant, the form can be signed.

Contact Information

Clinical Trials Office
330 Brookline Ave
Boston, MA 02215
617-667-4443
cto@bidmc.harvard.edu