Clinical Trials and Its Regulation

Clinical Trials are experiments or observations done in clinical research. They are prospective studies on human participants concerning new treatments. They generate data on safety and efficacy. They need approval.

Phases

Phase 0: pharmacodynamics and pharmacokinetics in humans (animal study)

Phase 1: screening for safety (first in humans)

Phase 2: efficacy against a placebo (in patients testing for efficacy)

Phase 3: final confirmation of safety and efficacy (larger number of ill patients, safety and dosage)

Phase 4: safety studies during sales (post-market, pharmacovigilance, large scale, long term, off-label prescribing monitoring such as yellow card scheme in British National Formulary)

Regulation (EU) No. 536/2014 regulates clinical trials in regards to authorization requirements and procedures, implementation as well as the creation of an electronic database for safety reporting. The Regulation further deals with the manufacture and import of investigational medicinal products and auxiliary medicinal products and their labelling.

The Medicines for Human Use (Clinical Trials) Regulations 2004

It includes the regulation of the ethics committees, authorization for clinical trials and ethics committee opinion, good clinical practice and the conduct of clinical trials, pharmacovigilance, manufacture and importation of investigational medicinal products, and labelling of investigational medicinal products.