Posted by Brigham and Women's Hospital May 30, 2013
Do you ever wonder why most doctors now recommend aspirin for heart attack prevention? The answer is more straightforward than you think: clinical research.
Clinical research at Brigham and Women’s Hospital revealed the effectiveness of aspirin as a first-line defense against heart attack in people who are at risk. Once broadly proven, the treatment was adopted and has helped thousands avoid the devastating effects of heart attack.
BWH is an international leader in cardiovascular research. With over 150 cardiovascular clinical research studies being conducted at any one time, there are opportunities for patients to participate in studies that may change cardiovascular care for millions. Before making a decision on whether to participate in clinical research, it’s important to understand what’s involved.
Clinical research involves studies led by doctors and researchers who are trying to answer specific scientific questions with the goal of finding better ways to prevent, diagnose, or treat diseases, and improve health care. Trials also are conducted to collect information on the safety and effectiveness of various treatments.
Based on the type of treatment being investigated and the stage of its development, researchers first enroll a small number of healthy patients into pilot studies. Pilot studies are followed by studies that involve comparing the new treatment with the currently prescribed treatment in a large number of patients. Clinical research studies vary in size and can take place at a single medical center or multiple medical centers in numerous locations.
All clinical research in the United States is strictly approved and monitored by an institutional review board (IRB) that makes sure the risks are as low as they can be and are worth any potential benefits. The research follows a carefully controlled study plan, called a protocol, and is reviewed regularly. Any new medicine or medical device must then be submitted to the U.S. Food and Drug Administration (FDA) for approval to meet certain set guidelines. Once the medicine or medical device is approved by the FDA, it is deemed safe and appropriate for specific conditions.
If you’re eligible for enrollment in a clinical research study, your doctor’s office may contact you or – if you see a study you’re interested in participating in – you can speak with your doctor. Clinical research studies have very strict criteria that all participants must meet in order to participate. Once accepted to a clinical research study and you have provided your consent to participate, you will be given detailed information on the structured plan that you need to follow. This may include a schedule of tests, visits to the doctor, and treatment.
Even though a clinical research study may not provide you with a direct benefit, it’s worth considering since it may help other patients in the future who have the same condition as you.
More information about clinical trials:
– Jamie R