In order to participate in a clinical trial in which Austin Primary Care Physicians is a participant, the patient simply needs to contact the clinic to let them know they’re interested.
Each trial is accompanied by a protocol, which details inclusion and exclusion criteria. That is, patients must meet certain criteria to participate in the study and certain factors can exclude a patient from eligibility in a study. The inclusion/exclusion criteria ensure integrity of the research and most importantly, safety of the patient.
Each patient must be adequately screened to ensure they meet all of the inclusion criteria and none of the exclusion criteria. This is done through a phone interview and an on-site screening appointment. Patients either fail the screening and are not able to participate in the study — but might be able to participate in other or future studies — or they pass the screening and are able to enroll in the study.
The primary risks associated with participation in a clinical trial include:
While the FDA only approves clinical research on drugs that they believe are safe, all medication is associated with inherent risk of allergic reaction or other adverse effects.
Clinical trials are designed to measure efficacy and over 90% of drugs tested don’t meet safety and efficacy endpoints, which means patients are at risk of participating in the trial and not seeing improvement in their condition
These risks are not different from the risks associated with taking medications approved by the FDA, but there are fewer known factors in a drug still in development phase.
The level of participation depends on the drug or device being studied and the condition it’s designed to treat. In most cases, patients are able to administer the medication at home, keep a diary of administration, and report back to the clinic at scheduled intervals for follow-up and evaluation.
Patients who participate in clinical research trials: