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#20 Clinical Trials -

Clinical studies involve research with volunteers to add to medical knowledge.

Participating in a trial is a personal decision that requires self-examination and study of the trial itself. These questions were taken from the www.clinicaltrials.gov website to help in discussion with the doctor. I underlined the first sentence because it is so important.

Once on the website, go to the advanced search engine. There you can enter the words “macular degeneration.” Then further define the search by:

  • state you live in (or states close by). Some trials would involve travel and repeated visits.
  •  entering male or female
  • “actively recruiting” participants (some trials are closed).

Most of the trials are testing various medications and combinations of medications. Often some patients will receive the meds being tested while others receive a placebo.

Questions to Ask

Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. Answers to some of these questions are provided in the informed consent document. Many of the questions are specific to clinical trials, but some also apply to observational studies.

1. What is being studied?

2. Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?

3.  What are the possible interventions that I might receive during the trial?

4. How will it be determined which interventions I receive (for example, by chance)?

5. Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?

6. How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?

7. What will I have to do?

8. What tests and procedures are involved?

9. How often will I have to visit the hospital or clinic?

10. Will hospitalization be required?

11. How long will the study last?

12. Who will pay for my participation?

13.Will I be reimbursed for other expenses?

14. What type of long-term follow-up care is part of this trial?

15. If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?

16. Will results of the study be provided to me?

17. Who will oversee my medical care while I am participating in the trial?

18. What are my options if I am injured during the study?

As defined by the U.S. National Institutes of Health, most clinical trials are designated as Phase I, II, or III, based on the questions the study is seeking to answer:

In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe and effective dosage range, and identify possible side effects.

In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to determine if it is effective and to further evaluate its safety.

In Phase III studies, the study drug or treatment is given to even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase IV studies, after the Food and Drug Administration has approved the drug, continuing studies will determine additional information, such as the drug’s risks, side effects, benefits, and optimal use.

Before human testing, usually animal testing is done.

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The injections we talked about in the earlier blogs underwent clinical trials with volunteers willing to try the drugs to see if they worked.

Would you be willing to volunteer in a clinical trial to test a new medicine or treatment to cure or prevent loss of vision?

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