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What You Should Know Before Participating in a PCOS Clinical Study

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Updated November 01, 2012

PCOS is one of the most common hormonal conditions affecting women of child-bearing years. That being said, physicians and researchers still aren’t sure what causes the condition, why women are affected by it so differently, and how to cure it. Many researchers are engaging in studies designed to answer these questions and address other issues. In order to obtain reliable results in these studies, they need a large group of women to study. While not for everyone, some women opt to participate in these studies to help advance our knowledge of PCOS and develop new treatments and therapies to manage the symptoms. Before signing up for a clinical trial, read on for basic information about clinical trials and what you need to know about participating in one.

What is a Clinical Trial?

Before approving a new drug or a new use for an old drug, the medication must be put through rigorous testing to make sure that the drug is not only effective, but safe. In addition, potential complications, contraindications (medical reasons why the drug should not be used) and side effects must be evaluated.

This happens in a series of studies and the results are presented to the FDA, or Food and Drug Administration. The FDA must approve both the drug or treatment and the research supporting its use before it can be prescribed.

Clinical trials can be used to study the effectiveness of treatments of a specific disease, methods of diagnosing or screening for the disease, ways to prevent the disease and ways to promote quality of life for people with a disease.

Phases of a Clinical Trial

There are three phases for a clinical trial. Phase I involves determining the safety of a drug, including the preferred dosage and safe range of dosages. Usually drugs in this phase will not have been tested on humans before. Participants will get varied doses of the drug and be observed for side effects or complications. Phase II trials investigate the efficacy of the drug. This means determining whether the drug will actually be effective in treating the drug that it was designed to treat. Drugs in Phase III trials will be compared against existing treatments to see which drug is more effective. Participants are randomly assigned to either the new drug or the old treatment. The participant doesn’t know which drug she is taking and in many cases, neither does the researcher. This ensures that there is no bias about the results from either the subject or researcher.

Finding Clinical Trials

You can start with a simple Internet search using the keywords “PCOS and Clinical Study”. Scroll through the results and see if there is a study close by that you might be eligible for. You can also start with the major medical centers close to where you live that is currently accepting study participants. Your physician or specialist may be doing research or be able to point you in the direction of a colleague who is performing a study. Finally, you can check the National Institute of Health clinical studies resources – their website is http://www.nih.gov/science/ - for more information about participating in a clinical study. They also have an easy to use search function (found at http://www.clinicaltrials.gov/) where you can enter the type of study you are looking for and a listing of all of the current projects is displayed. On the day that this was written, there were 285 available clinical studies.

Is It Safe For Me To Do This?

Keep in mind that researchers and physicians must adhere to a code of ethics and that they will take very specific steps to keep their study subjects safe. Their protocols must be followed, as well as safeguards specifically designed for the participant’s safety. Remember, if people couldn’t be kept safe during these trials, why would they be willing to donate their time and health to advance research.

Pay

In most cases, study subjects are compensated for their time and effort. The pay scale ranges and depends on what is allowed by the grant funding the study and what is required of the subject. In many cases, related medical care is also provided for over a period of time.

Questions to Ask Before Signing Up

  • What is the study about?
  • What are the procedures?
  • Who will get the results?
  • How long will it last?
  • Where will you need to go?
  • Is hospitalization or surgery required?
  • Will I need time off from work and will my employer be supportive?
  • If the medication or therapy is effective, will I be allowed to continue once the study has finished?
  • Has the medication or therapy been tested before and is it safe?
  • Have side effects or complications been reported?
  • What happens if I suffer from side effects or complications after the study?
  • Who oversees my care during this time?
  • What about after the study?
  • Who is administering the study?
  • Will I be paid for my participation?
  • What about my other expenses?
  • Will I get to know the results?

Informed Consent

Researchers are legally required to obtain informed consent before allowing your participation. This means that you must be fully aware of, and given the opportunity to ask questions about the study. Knowing that you are fully aware of what you are doing actually makes it easier for the study administrators to do their jobs, so please don’t feel silly asking your questions.

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