2012 Issue 2
REHABILITATION & RECOVERY
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Clinical Trials 101
Should you participate? What to know before you sign up
Patients interested in new and alternative medical therapies for stroke treatment often look into clinical research opportunities. In fact, post-stroke clinical trials are seeing increased participation each year.
During a clinical trial, experimental medicines and medical devices undergo a multi-phase, Food and Drug Administration (FDA)regulated investigation to determine their safety and efficiency before they’re approved for public use.
It’s important to be aware of the various steps and stages involved in a clinical trial before deciding to volunteer as a participant.
FOUR PHASES AND WHAT TO EXPECT
Testing begins with extensive laboratory research. Sometimes years of experiments in animal and human cells are needed before research is considered successful. Researchers then send data to the FDA for approval to continue testing in humans.
A specific protocol is outlined for the clinical trial, describing the types of people that can participate, schedule of tests, medications that will be used and the length of the study.
Four phases are typically conducted. Phase I will assess a drug’s safety and includes several months of testing and a small number of healthy volunteers (20 to 100), who are generally paid for participating.
Once the effects of the drug on humans are determined, the trial moves on to Phase II. This stage involves up to a couple of hundred participants and can last several months to two years. Studies are broken down into trials where one group receives the experimental drug and the other “control” group receives a placebo. Neither group knows if it’s receiving the drug or the placebo, allowing researchers to report unbiased comparative information to the FDA and the sponsoring drug company.
Phase III brings randomized and blind testing to several hundred or thousand of volunteers. This testing can take many years and delivers an in-depth understanding of the drug to pharmaceutical companies and the FDA. Once this phase is completed, the drug company can request FDA approval.
The final phase, IV, is often called a Post Marketing Surveillance Trial and is conducted after the drug is approved for consumer sale. Pharmaceutical companies are tasked with comparing the drug to existing drugs, monitoring long-term effectiveness and determining cost-effectiveness.
It’s important to note there are many studies that may include interventions that don’t require a drug or device, and may not be included in the FDA pathways. The same principles apply: Be aware of the steps and stages involved, make sure the trials are listed on CenterWatch or ClinicalTrials websites (listed at right), and get as much information as possible before committing.
Clinical trials are protected by strict government guidelines and volunteers can withdraw from a trial at any time. Every clinical trial in the United States must be approved and monitored by an institutional review board to make sure the risks are as low as possible. Before participating in a trial, participants must agree to sign an informed consent form, which provides detailed information about the study, medications and procedures that will be involved. Experienced physicians who have been thoroughly trained and designated as principal investigators also closely monitor participants.
While in a clinical trial, participants are seen regularly by the research staff to monitor their health and determine the safety and effectiveness of the treatment.
CLINICAL TRIAL BENEFITS
Stroke survivors participating in clinical trials can:
- Access new drugs, interventions and devices that aren’t yet available to the public
- Receive expert medical care during the trial
- Receive free study-related physical examinations, doctor visits, study medications and laboratory tests
- Feel as though they’re taking an active role in their own health care
- Contribute to important medical research
How to Find a Clinical Trial Near You
Stroke patients interested in clinical trials should be sure to take some time to research, ask questions and find the right trial that matches their personal needs and doctor’s recommendations.
A great starting point is www.CenterWatch.com
The site is a National Stroke Association Clinical Trials Research Center partner, and lists U.S. and international clinical trials for stroke that are actively recruiting volunteers. Use the website to search for clinical trials by region and state, sign up to receive email notices about new trials, search drug information and the latest FDA drug approvals and learn about the latest trial results. The site also offers a link to a patient bookstore containing brochures about the industry and how to identify and volunteer for clinical trials.
Another useful resource is www.clinicaltrials.gov
The site hosts a searchable database of federally and privately supported clinical trials conducted around the world. Browse information to find out about a trial’s purpose, who may participate, locations, contacts and a useful glossary of clinical trial terms. Click on the “What’s New” tab to learn about recently or modified studies. The site is updated daily and allows you to search clinical trials by location, as well as by specific condition.
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