Frequently Asked Questions

Clinical trial general information

What is a clinical trial?

A clinical trial is a research study involving human volunteers designed to answer specific questions about health issues. These issues included disease prevention, treatment using drugs or medical devices or other interventions. Clinical trials can:

  • Test whether new treatments are both safe and effective
  • See if they help or improve the illness or health problem

What happens in a clinical trial?

The clinical trial process depends on the kind of trial being conducted. The clinical trial team generally includes doctors, nurses and other research staff. The research staff will check your health, give specific instructions for being in the trial, watch over the participants carefully during the trial, and stay in touch for a time after the trial is finished. Some clinical trials have more tests and clinic visits than you normally would have for an illness or health problem.

What is a protocol?

A protocol is the study plan that outlines the clinical trial. It is a detailed study plan that tells what will be done, rules about types of participants that will be involved; tests, procedures, and drugs or devices that will be tested. The protocol also acts as a safeguard to monitor the health and well being of study participants.

What are the different types of clinical trials?

  • Treatment trials test new treatments, new combinations of drugs, or new devices and other therapies.
  • Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These may include medicines, vaccines, or lifestyle changes.
  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Screening trials test the best way to detect certain diseases or health conditions.
  • Quality of Life trials explore ways to improve comfort and the quality of life for individuals with certain illnesses.

What is a placebo?

A placebo is an inactive substance that is sometimes used in a clinical trial. This substance is compared to an active drug or device to determine the effectiveness of the treatment plan in question. Not every clinical trial uses a placebo.

What is a control group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as pharmaceutical and medical device companies, hospitals, universities, and the various Federal Government agencies like the National Institutes of Health (NIH). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

Participating in a clinical trial

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. These criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What are the possible benefits and risk of being in a clinical research study?

Possible benefits of being in a clinical research study

  • Participants play an active role in their own health care
  • Participants may gain access to treatments before they are widely available
  • Participants help others by contributing to medical research knowledge

Possible risks of being in a clinical trial

  • It is not known for sure if the new treatment will help a study participant more than the standard treatment for the particular illness or health problem
  • There may be unpleasant, serious or even life-threatening side effects to treatment.
  • Being in a clinical trial may require more trips to the study site, more tests or treatments, more complex medication schedules, more recording of information, or possible hospital stays

What should someone consider before entering a clinical trial?

You will want to understand all aspects of a research study before you agree to participate. You may wish to ask questions such as:

What is the study about?

  • What is the purpose of this study?
  • Who is sponsoring the research?
  • How long will the study last?
  • What happens at each visit?
  • How does the study differ from normal health care for the condition?
  • Can I take my regular medication while I'm participating?
  • Can I see my own doctor?
  • How will the information gained by this research be shared?

What about costs?

  • Are extra charges involved?
  • How much will my insurance cover?
  • Who is available to discuss insurance issues with me?

How are the rights and safety of research participants protected?

There are ethical and legal standards that apply to clinical research, just as there are in other aspects of healthcare. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. Groups of experts at the national and local levels approve research studies before they begin. One of the most important groups is the Institutional Review Board (IRB). Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, ensure that an IRB initially approves and periodically reviews the research.

To help protect confidentiality, individual participants' names will be disclosed only to those involved in the study and will not be mentioned in publications or other reports

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. Details in this consent process include the purpose of the study, its duration, the required procedures, all safety monitoring and potential risks and potential benefits. A member of the research team reviews an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and names of key contact personnel. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

  • Plan ahead and write down possible questions to ask.
  • Ask a friend or relative to come along for support and to hear the responses to the questions.

Does health insurance cover the cost of being part of a research project?

This varies by insurance plan and by study. Normal health care visits and procedures are usually covered. Potential participants should ask a member of the research team about costs before considering study participation.