Learn Details of the Advances Clinical Trials Market Forecast and Segments 2015 - 2025

Clinical trials are research studies performed on humans to gain specific information about biomedical interventions such as novel vaccines, devices, treatments and drugs and thereby generating safety data. Clinical trials are regulated by health authorities and ethics committees.

Documents required for performing clinical trials are investigator’s brochure (IB) which include current and relevant scientific information about the investigational product, United States Food and Drug (FDA) form 1572, protocol and amendments, inform consent, other written information for participants, recruitment advertisement, financial disclosure form (FDF), master clinical trial agreement (MCTA), institutional review board (IRB) approval, medical licensure, training records, laboratory accreditation, visit monitor reports, miscellaneous document, signature sheet and documentation of investigational drug destruction. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together regulatory authorities of Europe, the United States, Japan and experts from pharmaceutical industry to frame and regulate the technical and scientific aspects of pharmaceutical product registration. The Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) states rules and standard guidelines for clinical trials. ICH guidelines are followed as law by several countries in the world.

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Clinical trials are conducted in four phases namely, Phase I, II, III and IV. Phase I is conducted for safety, phase II is conducted for efficacy, phase III is conducted for final confirmation of safety and efficacy and phase IV is conducted for post sales studies. Risk to participants involved in clinical trials decreases from phase I to phase VI. Number of participants increases from phase I to phase IV...