Medical Clinical Trials

A medical clinical trial is a test or study of a drug on human volunteers. Medical clinical trials are conducted to test new drugs before they are submitted for approval by the Food and Drug Administration (FDA). Medical clinical trials can be sponsored privately or by the federal government. Medical clinical trails are conducted for treatment of hundreds of medical conditions from asthma to depression to Zellweger Syndrome. Medical clinical trials generally are conducted to test how a product compares to existing products for the same treatment, or if no treatment currently exists.

Doctors and other health professions running the test must adhere to strict rules and guidelines established by the FDA. These rules are established to ensure the safety of the patient during the trial. Studies are typically done in several phases. When a medication is being introduced, the medical clinical trial typically includes a relatively small number of very healthy individuals taking the drug in a closely controlled environment. This phase of the study is conducted to determine effective levels of medications, and determine any possible side effects.

The second phase of a medical clinical trial is broader. The patients' conditions may be more severe, but their health and emotional status are established in detail and they are closely monitored throughout the medical clinical trial period.

Some medical clinical trials involve the patient receiving the new drug for treatment of an identified condition. Other medical clinical trials are "double-blind" studies where neither the patient nor the medical practitioner knows if the patient is receiving the drug or a placebo (an inactive substance). This type of trial is most beneficial because it truly compares "apples to apples." In other words, patients who received the actual drug had improved symptoms and those on placebo did not have the drug. If the placebo patients note improvements, it is easier to document that the improvement was due to "mind over matter" vs. actual physical improvement in their condition.

If you would like to be considered for a medical clinical trial, results of the first study visit will determine your suitability for a particular trial. Blood and urine samples (usually fasting) will be taken. Your height, weight and blood pressure are established and often an EKG or other more complex test is done to establish a baseline, and to ensure you are eligible for the study, based on the criteria established. Detailed psychological and mental status surveys are typically administered as well.

If you are approved for participation in the medical clinical trial, you will be required to have follow-up visits frequently (every week or so, typically). The trial periods vary, depending upon the drug and the time period established by the study sponsors. I participated in a medical clinical trial several years ago that lasted 12 months. I enrolled in one recently that is expected to run for eight months. This time commitment is an important factor to consider before you commit to participating in a study.

The advantages of participating in a medical clinical trial far outweigh the disadvantages, though. The most important advantage is that you will receive a complete, thorough medical and psychological examination. Also, your health will be closely monitored throughout the study period.

Another important advantage is that the drugs are provided free of charge. My family doctor indicated to me that he has referred several indigent patients for medical clinical trials so they can receive treatment at no cost. Sometimes participants are also compensated for their participation in a medical clinical trial. The last study I participated in paid a per visit fee, but paid participants at the end of the study in a lump sum. The current study I'm involved in pays at the end of each visit. Even if participants don't complete the study, they are paid for the number of visits they attend, if payment is part of the study plan.

I like the fact that I am receiving free medication and that my physical condition is being closely monitored. What I am the most pleased about though, is that my participation in medical clinical trails helps other people. The results of the examinations and surveys and my self-report are going to be included in a report that will determine the effectiveness of a drug that could help many others when it is actually placed on the market.

If you have a medical condition, or suspect you do, I highly recommend you look into participating in a medical clinical trial. The website, http://clinicaltrials.gov/, provides information on hundreds of clinical trials being conducted. This site allows you to search by condition, sponsor, and status (are they recruiting participants, etc.) and also provides contact information for study sponsors.