What are clinical trials?
Clinical trials are scientific and medical trials conducted on healthy or ill subjects who have voluntarily given their consent to participate.
Clinical trials are used to gather information on the efficacy and safety of medicinal products, diagnostic methods, disease prevention methods, medical procedures (e.g. surgical procedures) or treatment methods. Trials are conducted for both new medicinal products and already approved medicinal products, which may be investigated in additional indications (other diseases), in new formulations, in special patient subgroups and the like.
Clinical trials are an important and irreplaceable part of advancement of modern medicine, disease treatment and healthcare. All medicinal products (e.g. pain, allergy or high blood pressure medications) have undergone development through a clinical trial.
Clinical trials are conducted according to predefined protocols and a number of international regulations, conventions, guidelines, and regulations of the countries they are conducted in. A large number of persons, as well as governmental and other authorities regularly review and oversee the entire clinical trial process, thus ensuring that all persons conducting a clinical trial comply with the required regulations and procedures.
The basic principles governing the conduct of clinical trials are protection of the rights and safety of the subjects, and of confidentiality, accuracy and reliability of the results. These principles are commonly referred to as Good Clinical Practice.
Clinical trials are necessary because sufficient information needs to be obtained in strictly controlled conditions and on a smaller number of people, so that, based on such information, the medicinal product can be determined safe for treating patients worldwide. This approach is referred to as ‘evidence-based medicine’. Results of clinical trials are used for registration of medicinal products in different countries across the world, for scientific purposes and to improve treatment guidelines.
Clinical trials are conducted in almost all countries in the world, but mostly in developed countries such as the USA, Canada, UK, France, Germany, etc.