Human Clinical Trials
During the development of new pharmaceuticals drug companies are required to test the effects, safety and efficiency of their products on animals and humans alike. Clinical trials involving humans are seen as both essential and of the utmost importance for medical research and also incredibly controversial. They can be designed to test the effectiveness and safety of drugs on a specific medical condition, test different dosing amounts, test improvements to already manufactured medications and more. Also, medication is not always the product being tested. Some studies research therapies, devices and interventions as well.
Clinical trials can involve either patients with a disease or disorder, or healthy individuals. For those that suffer from a specific medical condition they can benefit from receiving drugs that are not yet available on the market. Healthy trial participants are often compensated financially for their participation. The most common population to be recruited for these studies are healthy, young males. But whether ill or healthy, there is a general procedure that is followed by most clinical trials.
First, the trial sponsor or investigator identifies the drug being tested, the comparison placebo and the medical conditions that could benefit from the product. They then recruit the appropriate participants, administer the medication or placebo, monitor the effects and collect data including side effects, blood pressure, temperature, pulse and respiratory rate. This data is then analyzed by the sponsor. Many clinical trials require subjects to stay in the lab from 1-30 nights during the dosing period in order to monitor any unforeseen side effects.
Over the years, clinical studies have gained reputations for not reporting their findings as accurately as needed. Pharmaceuticals companies have been known to only report the positive results obtained through these trials. Today, all studies of this kind are closely regulated by appropriate authorities and an ethics committee, the Institutional Review Board (IRB). To begin, all studies must obtain full and informed consent from the test participants, meaning they have clear knowledge of the facts and of future consequences. Also, in some states researchers must be certified by the local IRB, which ensures they know and abide by good medical practices and federal patient privacy laws.
Clinical trials have their benefits and drawbacks as we have seen. If you are interested in participating in a research study of this nature, do your research first. Contact the local IRB and ensure the company recruiting participants is trustworthy. Being knowledgeable can be a great form of medicine, too.
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This entry was posted on Wednesday, October 8th, 2008 at 11:10 am and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
