A clinical trial is the process by which the safety and effectiveness of a drug or device is evaluated.
After a substance or compound is developed, usually in a laboratory, it will be first tested in animals. Treatments that demonstrate safety in animal testing will next be studied in clinical trials in a small number of healthy volunteers (phase I), followed by progressively larger groups of subjects with the target medical condition (phases II and III). A treatment must be proven safe and effective prior to receiving FDA approval for release into the general population.
Clinical trials are conducted according to FDA and other government regulations, and are closely monitored. In addition to seeking FDA approval, a drug or device maker may wish to make claims of product superiority over competitors. Such claims may not be made until clinical trials which support the claim(s) are completed.
2. What are the Driving Forces of Clinical Trials?
Clinical trials are sponsored by a variety of people and organizations. Medical organizations, government organizations, pharmaceutical corporations, and even individual physicians may sponsor clinical research. However, the majority of clinical trials are initiated and funded by larger organizations with the considerable infrastructure and resources necessary to support them. A great many are driven by pharmaceutical companies, who compete intensely with one another to develop drugs which will outperform existing treatments.
3. What are the Benefits and Risks of Participating in Clinical Trials?
There are potential medical, financial, and personal benefits associated with participating in clinical trials. A study participant may have access to a drug or device not yet available in the general population. The treatment may improve the condition being treated and possibly with fewer side-effects, although there is no guarantee of this.
Also, participation in studies usually results in closer observation of the study participants by the doctors and study staff. Often, diagnostic procedures are conducted in accordance with a study, which results in a better understanding of a person’s medical condition.
Additionally, there is usually multiple laboratory analysis and physical exams associated with the study, as well as expanded education opportunities.
Financial benefits of study participation may include no-cost medical care associated with the study, no-cost medication, and compensation for time and travel. The financial benefits of participating are provided to offset the extra time and travel costs associated with participating in a study. Personally, study participants may feel intrinsically rewarded by volunteering for research that may positively impact medicine, which may help large numbers of people.
There are also risks to participating in a clinical trial. Each trial is designed uniquely, but it is common that studies be placebo-controlled. This means that there is a possibly of receiving placebo, instead of active drug, during the study. Receiving placebo will likely result in no improvement in the condition being studied. Additionally, there may be side effects associated with the study therapy. Although early studies must show that an investigational drug/device be safe for continued study, some side effects may not become apparent until larger scale studies are conducted, or even later.
Prospective study participants should carefully read the Informed Consent document prior to entering a study.
4. What is the Impact of Clinical Trials?
The development of drugs and devices is an evolutionary process. If it weren’t, treatment would not progress. Clinical trials are a vital part of the development of treatments that are often in some way superior to existing treatments, or provide treatments where there are none. Consider for a moment the condition of health care today if treatments had not progressed over the past century. The point is, treatments today are radically different because of the evolutionary nature of medicine, of which clinical trials plays an important role.