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For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
The drug pipeline is also sometimes restricted to a particular drug class or extended to mean the process of discovering drugs (the research and development pipeline). [3] The R&D pipeline involves various phases that can broadly be grouped in 4 stages: discovery, pre-clinical, clinical trials and marketing (or post-approval).
The design of a clinical trial will depend on the drug and the phase of its development. Some clinical trials are conducted after a device or drug is approved to follow for safety. Control group is a group (or cohort) of individual patients that is used as a standard of comparison within a clinical trial. The control group may be taking a ...
Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks. Other commitments are commitments to obtain informed consent from the research subjects, to obtain a review of the study by an institutional review board (IRB), and to adhere to the investigational new drug ...
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments. [ 3 ] [ 4 ] Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled.
The trials are typically conducted in three phases: [5] Phase 1: The drug is tested in 20 to 100 healthy volunteers to determine its safety at low doses. About 70% of candidate drugs advance to Phase 2. Phase 2: The drug is tested for both efficacy and safety in up to several hundred people with the targeted disease.
In 2010, the research and development cost of each new molecular entity was about US$1.8 billion. [8] In the 21st century, basic discovery research is funded primarily by governments and by philanthropic organizations, while late-stage development is funded primarily by pharmaceutical companies or venture capitalists. [9]