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GLENN ELLIS' STRATEGIES FOR WELL BEING: Clinical Trials
*As new medical treatments and drugs are developed, volunteers are needed for clinical trials to help ensure that treatments are safe and effective. A clinical trial is a research study to test a new drug, device or treatment strategy on humans. Advances in medical treatments have occurred because of the application of new knowledge gained from clinical experiments conducted over the last 250 years.
Clinical trials are a vital and necessary part of America's medical research system. They have proven to be the best mechanism for testing potential drugs and separating the ones that work from the ones that are ineffective or potentially harmful.
Many of the early advances in medicine were made at the expense of many marginal groups such as asylum inmates and prisoners. These test subjects were involved in these clinical trials without being informed, or even asked.
One of the major events that brought the issue of clinical trials to the public was the revelation of the Tuskegee Syphilis Study. The study was conducted by the United States Public Health Service. The Tuskegee study began in 1932 and continued till 1972, when it was revealed to the public. The purpose of the study was to examine the long term affects of syphilis. The subjects of the study were 400 African American males, who were primarily poor sharecroppers. These men all had syphilis, but were unaware of it. They were also unaware of the true nature of the experiment. The most horrifying aspect of the experiment was in the 1950’s penicillin was proved to be effective at curing syphilis. The researchers did not treat the syphilis and even prevented other doctors who saw the participants from treating the syphilis. As many as one hundred men may have died from complications from their untreated syphilis. The study was revealed in 1972 by a newspaper article that shocked the country and caused the project to be shut down. It wasn’t until 1997 that President Clinton formally apologized for the study.
Informed consent is one of the most important “safety nets” in clinical trials. Doctors are obligated to make sure that a patient understands the risks and benefits of any medical procedure. Requiring informed consent protects many marginal groups from being forced to participate in medical studies without understanding the risks involved. Medical advances should not require some people to sacrifice their health and rights for the good of all. Informed consent is a key instrument in protecting these rights.
At the start of the four “Phase” clinical drug trial, developers concentrate on the tolerability of a new drug. These Phase I studies are usually carried out on a small number (20–100) of healthy volunteers. The aim of Phase II studies, which include 100 to 500 patients, is to determine whether the new drug is effective in the disease for which it is intended and what its potential side effects are. Phase II studies also serve to determine the dosage range, i.e. the highest tolerable and lowest effective doses, for the subsequent large-scale Phase III studies.
To this end, the patients are divided into two study groups. One patient group (the drug group) receives the drug being tested, while the other (the control group) receives a standard medication or placebo (placebo group). A placebo is a dummy pill, tablet, capsule, or solution that is identical in color and taste to the drug but contains no active ingredient.
For ethical reasons, in the case of severe and life-threatening diseases such as cancer and Aids, both groups continue to take their standard medications as well as the new drug or placebo.
Most clinical drug trials are based on a “blind” design, i.e. the patients are unaware which group they have been assigned to. In many cases, moreover, neither the patients nor the developers know who is receiving the test drug. Such trials are referred to as double-blind studies.
Phase III studies are carried out on large groups of patients (1,000 to 5,000) for whom the new drug is ultimately intended. The inclusion criteria that determine which patients can be enrolled in the study are often less stringent than in Phase II. Patients who differ in terms of gender, age, ethnic origin, lifestyle, diet, and state of health are randomly selected.
In order to recruit the large number of voluntary patients required, the studies are usually organized on at a number of hospitals and medical practices.
Once approval has been granted by the regulatory authorities, the pharmaceutical company is allowed to market the drug. Even then, however, the manufacturer has to submit to the regulatory authorities a precisely scheduled series of reports (phase IV) to document very rare side effects of the drug which occur in, say, only out one of 20,000 cases and which can therefore escape notice even in the Phase III trials.
As beneficial as clinical trials are, there are concerns. In all things you must “follow the money”. Costing upwards of a half billion dollars, and taking up to ten years before any return on investment, the stakes are indeed high. Private corporations, not the government, have been the largest sponsors of pharmaceutical research in both the United States in the last twenty years.
While doctors have a right to be reasonably remunerated for the work they perform, inappropriate remuneration raises the possibilities of:
• Erosion of the patient’s informed consent;
• Enrollment of ineligible subjects or subjects on the margins of eligibility;
• A coercive enrollment environment, e.g., patients agreeing to be subjects simply because they fear losing the caregiver if they say ‘no’; and
• Doctors, under pressure to increase their income, being inclined to perform research that they are not qualified to do.
Here are some other questions to keep in mind about clinical trials: Do they offer false hope? Do enough people take part? Is it better or worse if a study is funded by a large pharmaceutical company?
What are your thoughts? What experience have you had with clinical trials?
I don't think much has been written about this in the United States, but it's time we started talking… and thinking.
Remember, I’m not a doctor. I just sound like one.
Take good care of yourself and live the best life possible!
Glenn Ellis lectures and is an active media contributor nationally and internationally on health related topics, including health education and health promotion particularly relevant to the African-American community.
e-mail me at info@glennellis.com
For more good health information, visit: www.glennellis.com
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