Clinical trials are research studies on human subjects designed to answer specific questions on biomedical or behavioral interventions (novel vaccines, drugs, treatments, devices or new ways of using known interventions), generating safety and efficacy data.
Depending on the type of study, volunteers or patients can be enrolled.
For interventional clinical trials with drugs/devices usually 4 phases are foreseen:
- Phase I the new drug/device is tested in human subjects for the first time. The aim of this phase is to determine the tolerability and the maximum dose that can be given to human subjects.
- Phase II only selected human subjects are included according to the results of the phase I. The aim of this phase is to determine the activity of the drug/device.
- Phase III comparison of the new drug/device with the standard treatment. The aim of this phase is mainly to evaluate the efficacy and quality of life.
- Phase IV post-marketing surveillance.
Individual or organization which takes the responsibility of the clinical trial. The sponsor is responsible of the quality through written processes. It is also responsible of the trial design, partners involvement, drug/device management, selection of participating sites, Regulatory Authorities submissions, safety information, monitoring, complete and “clean” data collection.
It is the person responsible to run a study and treat subjects in a participating center (Institute, Hospital, Organization, etc). The investigator must be adequately qualified and have the appropriate experience. An up-to-date CV must be available and evidence of GCP training and experience in clinical trials must be available. The investigator should ensure the delegation of study-related duties to experienced-and trained personnel, that adequate facilities and equipment are available, the correct drug/device handling, a good quality in data collection and the adequate time to perform the trial. Subject protection in terms of safety and confidentiality must always be guaranteed.
Any healthy volunteer or patient who decides to participate voluntarily to a clinical trial. Before any procedure is carried-out the patient/volunteer must be adequately informed on the clinical trial (procedures, benefits, risks, rights and obligations) and an Informed Consent Form must be signed and dated.
Clinical Trials and Good Clinical Practice (GCP)
Clinical trials must adhere to GCP guidelines of the International Conference on Harmonization (ICH). These standards have been adopted by the Regulatory Authorities, Industries and academic researchers/research organizations in Europe, USA , Japan and other countries.
Subjects protection and collection of reliable data are important in all trials and strict adherence to GCP ensures that the quality processes are in place to meet these goals.