Clinical Trials What You Need to Know

Medical research studies

Being part of clinical trials is an opportunity to potentially change people’s lives by helping to bring a much-needed drug to market. Getting there, though, is not easy and the process of embarking on clinical trials is a lengthy and complicated one. Here’s what you need to know before signing up for a clinical trial:

Ask and You Shall Receive
Any person participating in a clinical study must give what is called informed consent. In fact, this aspect is so important it is has its own section in the 9th revision of the American Psychological Association’s Ethical Code. There are detailed guidelines about informed consent. Essentially it is the process of asking for your consent to participate in a clinical drug development study. You should be provided with sufficient information to make an informed decision about whether or not you want to take part in the trial.

When it comes to the participation of children in medical research studies, informed consent is even more important. Those under 18 cannot give informed consent themselves and researchers need to ask their parents or guardians for permission for them to participate. Again detailed information about the risks and process should be provided.

It’s a Phase
Clinical trials involve a series of phases that look at different aspects of drug testing. For example a phase 1 clinical trial is usually relatively small with between 20 and 80 people participating and aims to examine the safety of a trial drug and its potential side effects. Phase 2 then is a bit larger — 100 to 300 participants — and looks deeper into the safety of the drug and how effective it is. Phase 3 expands the testing pool further to between 1,000 and 3,000 people and examines everything from the effectiveness of the drug to monitoring side effects, comparing the test drug with similar drugs on the market, and collecting other information related to safe use of the drug. Finally, Phase 4 is the point at which a New Drug Application (NDA) is submitted to the FDA for approval to go on the market.

The length of time for clinical trials seems to be increasing with the average trial lasting 460 days in 1999, in comparison to the average of 780 days in 2005. Longer studies mean a better understanding of the drug’s potential, both good and bad.

A Small Chance
While being part of a clinical trial can be an exciting, if often challenging, experience, it doesn’t necessarily mean that the drug will actually make it to the shelves of your local pharmacy. Consider the fact that from the 5,000 to 10,000 drugs in development every year, just one actually makes it past FDA approval. Only 250 make it to pre-clinical trial testing and just five make it to clinical trial testing. The process itself, though, is very valuable and ensures that drugs that do actually make it to the shelves are as safe as possible and are their effectiveness and limitations are understood by researchers.

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