A clinical study follows a strict set of directions, called a protocol. The protocol includes a list of inclusion criteria volunteers must meet in order to qualify for the study; there is also a corresponding list of exclusion criteria that can exclude a volunteer from the study. The inclusion/exclusion criteria serve to find volunteers appropriate for the condition being studied who can safely participate in the study.
Once a volunteer has undergone the Informed Consent process (to be discussed in a future blog!), the next step is a thorough review of the volunteer’s medical history. The status of many, but not all, of the inclusion/exclusion parameters can be determined by this chart review. Additional evaluations, to determine volunteer eligibility and safety, are required. Typically, this will include a physical exam with the study doctor in addition to routine blood work, an EKG and perhaps, depending on the treatment being studied, more specialized testing such as a chest x-ray or a breathing test.
Completing all of the requirements for screening can be a lengthy process and sometimes, for the comfort of the volunteer, the screening process will be broken into multiple shorter visits rather than one very long visit. The practical side of this from the volunteer’s perspective is that there are frequent visits to the Research Center at the beginning of the study, maybe as many as three visits during the screening process.
The screening process is complete once the study doctor determines the volunteer’s eligibility in the context of the study parameters and volunteer safety. If the volunteer is eligible (and desires to continue), the volunteer is included in the study. In research-speak, this means the volunteer is randomized into the trial and will now receive the study treatment. Throughout the trial the health of randomized volunteers is monitored very closely by the study doctor and the rest of the research team.
Sometimes interested volunteers are found to be ineligible for the study. In research-speak, this is known as a screen failure. Volunteers who undergo the full screening process are usually compensated with a stipend for their time but more importantly, their participation and subsequent screen failure may be beneficial in the design of future clinical trial protocols. Also, there are sometimes advantages to the patient for having undergone the screening; see my earlier blog titled Sometimes a Screen Failure is Not a Failure.
As always, if you need more information about clinical studies contact Josh at the Clinical Research Center at 541-754-1398, option 7, or send an email to research@corvallisclinic.com.
– Julie Carrico is Associate Coordinator of The Corvallis Clinic Clinical Research Center
