Pharmaceutical companies, research institutions, or other health organizations sponsor a clinical research trial. Sponsors are responsible for funding and for designing the trial protocol (the set of detailed guidelines that investigators follow in order to conduct the same clinical research trial at different locations). Trained doctors, nurses, and medical researchers conduct the trials.

Participating in a clinical research trial is much like a regular visit to a doctor’s office, but with even greater personal attention. The success of any trial depends on its volunteers. Patients are treated professionally and with care.

Risks vary from trial to trial. Known risks and discomforts will be explained by the study physician prior to each patient’s participating in the study. In addition to the known risks, there may be unknown risks such as medication side effects. While it is possible that some side effects could be permanent or even life threatening, most are temporary and will go away as soon as the treatment is stopped.

Each trial has certain requirements (for example: diagnosis, medical condition, and age), and patients must meet these requirements. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Once a patient is enrolled in the trial, there are very specific guidelines which must be followed.

For the eligibility requirements for a particular trial, contact the Research Department at The Vancouver Clinic to speak to the coordinator for that study.

Volunteers need to be at appointments on time, to follow instructions carefully, to return phone calls from the study coordinator, and especially to take any medication exactly as told. This is needed in order to collect the information necessary for a successful study.

Prior to enrolling in a trial, volunteers should expect to receive complete information about the trial. They should not participate in any clinical research trial unless their questions have been reasonably answered.

Study procedures, risks and benefits are explained to volunteers during the informed consent process. This is required by law to make sure volunteers understand what is involved in a trial.

Volunteers can also expect complete information about the schedule and duration of the trial, directions to the trial location, and the name of someone to contact with questions or problems.

As patients under doctor’s supervision, volunteers are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect volunteers by making sure they have been given all the necessary information about a trial. An institutional review board (IRB) reviews the general progress of the trial. The IRB also regulates clinical research trial advertisements to reduce misleading claims.

Volunteers are always free to change their minds and stop participating in a trial at any time. They should keep in mind, however, that when even a few patients stop participating mid-trial (because of disinterest or other reasons), there may not be enough patients remaining to achieve reliable results.