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Facts About Clinical Trials

Choosing to participate in a clinical trial is an important personal decision. Participants need to educate themselves and ask many questions before enrolling in a trial. They should also discuss the  benefits and risks of participating in a specific clinical trial with their physicians, family and friends. Here are some resources to help with the decision-making process.

The National Institutes of Health's ClinicalTrials.gov website includes an "Introduction to Clinical Trials" with helpful questions and answers about clinical trial participation. Selected Q & As from this website are shown below.

To find clinical trials for Parkinson's Disease that are currently enrolling subjects, visit PDtrials.org  - specifically for Parkinson's Disease trials or ClinicalTrials.gov  - a clinical trial registry for all conditions and diseases.

The next step is to contact the study research staff and ask questions about  their specific trial. Suggested questions are available at PDTrials.org.

The Parkinson Pipeline Project is currently developing a "Bill of Rights for Parkinson's Clinical Trial Participants." A draft version is available at: Declaration of Rights


What is a clinical trial?

Why participate in a clinical trial?

Who can participate in a clinical trial?

What if the clinical trial I qualify for and want to
participate in is not within driving distance of my home?

What happens during a clinical trial?

What are the different types of clinical trials?

What are the phases of clinical trials?

What is a protocol?

What is a placebo?

What is informed consent?

Does a participant continue to work with a primary
health care provider while in a trial?

How is the safety of the patient protected?



What is a clinical trial?

A clinical trial is a research study involving human volunteers to answer specific health questions. It is the fastest and safest way to find treatments that work in people and ways to improve health. Clinical trials compare the way different groups of patients respond to different courses of treatment. A controlled clinical trial compares patients receiving a course of treatment with patients receiving no treatment (controls), to assess how much of an effect the treatment has.

Why participate in a clinical trial?

Participants can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical trial?

All clinical trials have specific guidelines about who can participate. Using inclusion/exclusion criteria 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."

What if the clinical trial I qualify for and want to participate in is not within driving distance of my home?

Most clinical trials are conducted at larger medical school or research facilities because of the need to follow a strict protocol and the expense involved in doing so. These facilities aren't always within driving distance for many patients. If you see a trial that interests you, but is being conducted far from home, call the contact person given and ask whether money is available to defray patients' travel expenses if this is a barrier to participation. The answer will help you make a better informed decision. 

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted (See: Types of clinical trials). A team of health care professionals checks participants’ health at the beginning of the trial, gives specific instructions for participating in the trial, monitors participants carefully during the trial, and stays in touch after the trial is completed. Some trials involve more tests and doctor visits than the participant would normally have. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

What are the different types of clinical trials?

  • Treatment trials are the most common. They test new or alternative potential treatments for specific diseases or medical conditions, new combinations of drugs, or new approaches to surgery or radiation therapy.

  • Prevention trials seek better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

  • Screening trials test new ways to detect specific diseases, especially diseases that may have an early stage before they produce symptoms.

  • Diagnostic trials look for tests or procedures that could be used to identify disease more accurately or at an earlier stage.

  • Genetics studies, sometimes part of another clinical trial, may focus on how genetic makeup can affect detection, diagnosis, or response to treatment.

  • Quality of life (or Supportive Care) trials explore ways to improve comfort and the quality of life for individuals with a chronic illness

  • Other types of medical research studies involve people but do not involve new procedures. They range from experiments assessing the quality of new questionnaires to tests of organ functions.

What are the phases of clinical trials?

Clinical trials are conducted in phases, each of which has a different purpose and helps scientists answer different questions:

  • In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

  • In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

  • In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

  • In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal uses.

What is a protocol?

A protocol is a study plan designed to obtain answers to specific research questions. It describes who may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. During the trial, the research staff regularly monitors the health of participants to assess the safety and effectiveness of their treatment.

What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. (See Placebo Effect). 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. Results are compared to assess the new treatment's effectiveness.

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. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The patient then decides whether or not to sign the document. Informed consent is not a contract. The participant may withdraw from the trial at any time.

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.

Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

How is the safety of the patient protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, which details what researchers will do.

 


Sources

Center for Information & Study on Clinical Research Participation
An Introduction to Clinical Trials

National Institutes of Health. ClinicalTrials.gov

NIH Fact Sheets Medical Research Clinical Trials
 

Copyright© 2012 Pipeline Project

All rights reserved. Revised: 01/26/12.