Clinical trials are generally defined as biomedical or other health-related studies in humans that are conducted according to pre-defined protocols. During the studies, the subjects are assigned to a treatment or some other intervention, and the final outcomes of these trials are observed and measured by the investigators. There are many reasons for which people may wish to contribute in a clinical trial. Most of the patients enrolled in the treatment are actually trying to obtain access to completely new treatment options that are not yet widely available. Also, people may wish to participate in a clinical trial because of their wish to help others by contributing to medical research. Clinical trials are conducted in many countries around the world. In the United Kingdom, participants of clinical trials are protected according to the Clinical Trials Directive, which is based on European legislation and aimed at balancing values for clinical trials throughout the European Union.
Risks of participating in clinical trials
Participants in a clinical trial will certainly play an active role in their own healthcare and may obtain medical care and treatment that are not available to other patients. In many cases, their help in contributing to medical research will be rewarded as they will obtain expert medical care from leading health care facilities in the United Kingdom. However, there are some risks to clinical trials as many experimental treatments may result in serious and even life-threatening side effects. Moreover, a treatment may not be effective for the patient, which can negatively affect total outcome of the disease.
Safety of the participants in the UK
As already mentioned, clinical trials in the United Kingdom are conducted according to the strict rules of Clinical Trials Directive, which are based on ethical and legal codes that protect the participants. Names and personal information about participants is always kept secret and their names are never mentioned in the reports.
UK regulations for clinical trials
Stationary instrument that regulates clinical trials in the United States is known as the Medicines for Human Use (Clinical Trials) Regulations 2004. This is actually already mentioned EU Clinical Trials Directive, transposed into the United Kingdom law in 2004. However, these regulations apply only those investigations and studies which are undertaken to establish the efficacy or safety of a medicine in human subjects. Non-interventional trials are excluded from these regulations. The regulations also apply only to those medicinal products that are to be tested or used as a reference in a clinical trial.