What to Expect from a Clinical Trial

The clinical trial process for volunteers depends on the kind of trial being conducted.

• Treatment trials test investigational treatments, new combinations of drugs or new approaches to surgery or radiation therapy.
• Prevention trials look for better ways to prevent a given disease from occurring or returning.
• Diagnostic trials are conducted to find better medical tests or procedures for diagnosing a particular disease or medical 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 people with chronic illnesses.

Clinical trials are conducted by research teams, often called site staffs. The role of the site staff is to check volunteers’ health throughout the trial, provide specific instructions and guidance for what to do during the trial, and make sure that the study protocol – a detailed plan for each clinical trial – is followed.

Getting Started: Steps for Potential Clinical Trial Volunteers

The following steps can help potential volunteers get started:

1. PPD has a research study volunteer database for potential volunteers. When a trial matching a volunteer’s criteria is enrolling participants, he or she will be contacted.
2. The potential volunteer will go through a screening process to make sure he or she qualifies for the trial.
3. If the potential volunteer is eligible to participate, the site staff will talk to him or her about the details related to participation and answer any questions. The site staff will also ask the potential volunteer to review and sign an informed consent form.

Clinical Trial Volunteer Physical Exam

To determine if a potential volunteer meets the requirements for a clinical trial, a physical exam is likely to be conducted. It may include:

• Measurement of height, weight, temperature and blood pressure
• A heart trace (electrocardiogram)
• An analysis of blood and urine
• Other diagnostic tests required by the study protocol

All of the information obtained during the screening process is kept confidential.