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Are clinical trials safe?

Strict guidelines and supervision are in place to protect the safety of people who take part in studies—from careful study design to periodic monitoring of study data by independent experts. That said, clinical trials are designed for research purposes, and because of this, there is some level of risk involved. However, before an investigational drug can be given to clinical trial volunteers, researchers must complete a rigorous screening and preclinical testing process (in the laboratory and in animals), which can take up to six years to complete.

If I participate in a clinical trial, will I get a “sugar pill” or placebo instead of a real drug?

Participants in a clinical trial using a placebo will always be informed if there is a possibility they could be receiving the placebo, which looks identical to the real drug but does not contain the active ingredient. However, the vast majority of studies are not placebo-controlled trials, and patients in the clinical trial who are not receiving the drug under study will receive the current standard of care available to the public. Patients who take part in clinical trials will never be asked to sacrifice quality of care.

Will it be expensive to participate in a clinical trial?

Patient care costs are generally covered by health insurance, as they are for tests and treatments you would receive even if you were not involved in the research. The majority of participants in clinical studies receive at least some reimbursement from their health insurance. Most often, the clinical trial sponsors will pay for the study therapy and insurance companies will pay for the routine care procedures, such as blood tests.

Before participating in clinical trials, I recommend checking with the researchers regarding your financial responsibilities as a patient, as well as with your health insurance carrier regarding coverage.

How do I find out about clinical trials?

You can always talk to your doctor; however, he or she may not know about all available clinical trials that might apply to you. Only approximately 1 in 5 patients say that their health care professionals have talked to them about participating in a clinical trial.

As for resources, the National Institutes of Health has an online database that is a great tool to search for appropriate trials: https://clinicaltrials.gov. Another great resource is “I’m In,” a campaign to build awareness about the importance of diversity in clinical trials, especially among African Americans, Asian Americans, and Hispanic populations. You can find more information on Pfizer’s Clinical Trial page, too.

What’s the timeframe for clinical trials?

I’m often asked, “Why does a new treatment take so long?” The short answer is that treatment takes as long as it does because the cardinal rule of medicine is “First, do no harm.” Thus, the development of a new therapy is a multi-stage, complex process that has to meet the highest standards of patient protection.

Clinical trials, which generally take 5 to 10 years, are at the center of the rigorous science that demonstrates the safety and efficacy of a medicine and provides a thorough view of its benefits and risks, and is the only avenue to bring medications to patients in need.

The next Ask Dr. Kevin article will appear next year. Meanwhile, here are resources to find more information about sickle cell disease, the collaboration between the NNPA and Pfizer Rare Disease, and a new nationwide poll conducted by Howard University to deepen understanding and gauge perceptions around SCD and clinical trials among African Americans.

(Dr. Kevin Williams is the chief medical officer for Rare Disease at Pfizer.)

 

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