Clinical trials involve a number of different organisations. Often, clinical trials are designed, planned and sponsored by a pharmaceutical company or a public health agency. These organisations may subcontract the implementation, monitoring and reporting of clinical trials to a contract research organisation (CRO). The design, monitoring, analysis and reporting of clinical trials require specialised scientific expertise contributed by the staff employed by the pharmaceutical company, the health agency, or the CRO.
Clinical trials are conducted in hospital departments, GP surgeries, or specialist phase I units, depending on the phase of the trial and the patient population under investigation. There will be a team of doctors, scientists, nurses and other medical and healthcare professionals running the clinical trial, which will be led by a doctor with a number of years research experience (the principal investigator).
Before a trial can start, it is reviewed by the regulatory body of the country where the trial is taking place to ensure strict regulatory guidelines are being followed in the design and planned conduct of the trial. It is then reviewed by an Ethics Committee (or Ethical Review Board) to ensure that the patient’s or volunteer’s rights are protected, and the highest standards of clinical practice will be observed to ensure the safety of the patient or volunteer.