When the idea of participating in a research study is first proposed to patients, they naturally have questions about safety. This blog will discuss ways in which clinical studies are designed to make participation as safe as possible.
First, study protocols must undergo a formal review process and receive approval from an independent Investigational Review Board (IRB) before clinical trials can begin. IRBs are charged with conducting an evaluation to determine if the study protocol has appropriate patient safety and fairness designed in. It is illegal for the clinical study to commence without this approval.
A second safeguard is that before study volunteers can begin a clinical trial treatment, they must undergo tests designed to help the study doctor assess the following:
- If the patient is eligible
- If it would be safe for the patient to participate.
Examples of this type of “eligibility/safety” testing include blood pressure readings, blood work to assess such things as liver and kidney health, EKGs, chest xrays or MRIs. If the patient does get enrolled, some of this safety testing is repeated at specified intervals. The study doctor will evaluate the test results to determine if the patient can continue in the study.
Once a patient is receiving study treatment, additional safeguards are in place. Data collected at each visit must be entered into a global database within 48 hours (note: patient-identifying information is not entered). Even though our site may only enroll a small number of patients, data are being entered for hundreds of patients at hundreds of other clinical study sites. Analysts evaluate the combined data in real time to look for trends, especially those that might indicate a safety issue. Any concerning safety data must be reported immediately to the IRB, who will determine if the study can continue.
Some studies take patient safety further and will appoint an Independent Data Monitoring Committee (IDMC) who is charged with ongoing data analysis and who must produce periodic reports on patient safety at specified intervals. For example, our site is currently participating in a study for a potential new medication for those with mild Alzheimer’s disease, called the Amaranth Study. When the Amaranth study started, a relatively small number of people (about 250) had taken the drug. In order to assess ongoing safety of participants in the Amaranth study, the IDMC must produce reports on patient safety at three defined intervals during the study.
Patient safety is of paramount concern in clinical trial design, but patient volunteers must be well informed of the risks and benefits to participation.
The Clinical Research Center is currently seeking volunteer patients in studies for Alzheimer’s disease, Type 2 diabetes, those with very high triglyceride levels, and COPD.
If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Requestform. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.
– Julie Carrico is Associate Coordinator of The Corvallis Clinic Clinical Research Center
