Why participate in a clinical trial?

Participants in clinical trials play a key role in drug development and discovery, clinical trials contribute to knowledge and progress in treating and preventing diseases. First and foremost participants can help others by contributing to medical knowledge and improving public health. Further, a participant does not need to be a patient diagnosed with a specific disease or health problem as some clinical trials, focusing on safety, will include healthy volunteers.

Patients who take part in clinical trials may benefit from the treatments they receive. As part of a clinical trial, a patient will receive either the experimental treatment being tested, an accepted standard treatment for the condition, or a placebo. It is important to understand that there is no guarantee that any treatment received in a clinical trial will produce the desired results.

Who can participate in a clinical trial?

Before joining a clinical trial, a participant must meet certain criteria. This is an important aspect of any clinical trial to ensure that the treatment is being investigated accurately and safely. 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 used to identify appropriate participants. Acceptance of a participant into a clinical trial is based on such factors as age, gender, the type and stage of disease, previous treatment history, and other medical conditions. For example, some research studies seek participants with specific illnesses or conditions, while others need healthy participants. Some studies may include only men, some studies may include men and women but not women of child-bearing potential, and some studies may include men and women within a specific age range (ie, 18-65 years of age). These criteria are defined by the amount of scientific and safety information that is known about a treatment being tested at the time the trial is planned to start.

What are the benefits and risks of participating in a clinical trial?

Benefits include:
– playing an active role in one’s health care
– gaining access to vaccines and treatments that may not be available for a significant amount of time
– helping others by participating in the trial so the treatment can potentially be approved and made available to the public

Risks include:
Participation in a clinical trial may involve some risks that your doctor will explain in more detail. These risks include:
– side-effects that are known and those that have not yet been identified;
– risks associated with study procedures;
– the experimental treatment may be ineffective or less effective than the current standard;
– the experimental treatment may not work for every patient.

Additionally, in some clinical trials the patient may not receive the experimental treatment,but the current standard or a placebo. In addition to the risks listed above, the trial might require the participant’s time and attention—including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What should one expect during a clinical trial?

For all types of trials, participants work with a research or clinical trial team, including doctors, nurses, social workers, and other health care professionals. Prior to the trial, the research team will check the health of the participant and review any special instructions for trial participation. As the trial begins and throughout its duration, the research team will administer treatment, (whether that be the experimental treatment, a standard treatment or a placebo depending on the requirements of the study) and monitor the participant on a regular basis to determine effectiveness and side-effects of the treatment. Ongoing communication is an important part of any clinical trial and after the trial has been completed the research team will stay in touch with the participant for a specified period of time to assess any effects of the treatment after treatment has stopped. The data collected before, during and after the trial is a crucial component to the drug’s approval submission to drug regulatory agencies.

What is informed consent?

Informed consent is the verification of a person’s willingness to participate in a research project. Prior to enrollment in a clinical trial, researchers inform participants about all relevant study details and known risks. Participants are then provided an informed consent document that details all the important study information including its purpose, duration, risks, potential benefits, required procedures, and key contacts. Once participants have had a chance to read this form and ask questions, if they agree to participate in the trial,they will be asked to sign an informed consent document. The informed consent document is not a contract. Participation in the clinical trial is voluntary and the participant may withdraw from the trial at any time without penalty or loss of benefits to which he/she is otherwise entitled. The research team actively maintains informed consent throughout the entire trial by providing the participant with any new or developing information, as needed.