A clinical trial is any research study that prospectively assigns human participants* or groups of humans to one or more health-related interventions** to evaluate the effects on health outcomes. (http://www.who.int/topics/clinical_trials/en/)
* healthy as well as diseased people
** psychological, physical, medical and nutritive treatments as well as surgical and diagnostic procedures, nursing care measures, etc.
The aim of clinical trials is to test the efficacy and safety of drugs or treatments as well as of medical interventions and devices.
Clinical trials help answer scientific questions and improve medical treatments.
A clinical trial is organized, conducted, monitored and evaluated by pharmaceutical, cosmetic and medical device companies and/or a contract research organization in cooperation with clinicians, ethics committees and authorities.
Clinical trials are based on gaining knowledge and must be strictly separated from marketing activities.
Procedure of a prospective*** trial:
- Planning (design, protocol, trial folder)
- Survey (intervention, monitoring, audit****)
- Completion (data management, evaluation, interpretation, final report, publication)
*** A prospective trial is the review of the medical or psychological efficacy of a treatment.
**** Audit: A systematic and independent review of trial-related activities and documents to determine whether the reviewed trial-related activities were conducted in accordance with the protocol, the sponsor’s standard operating procedures (SOPs), the good clinical practice (GCP), and the valid legal regulations, and whether the data was documented, evaluated and correctly reported according to these requirements.