| All research studies
done on humans are termed as Clinical Trials. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings. The trial on humans are adequately guided by the regulatory authorities. Patient Safety is of paramount importance in the conduct of any clinical trial.
Clinical Trials is conducted in 4 stage modules or Phases (phase 1 to Phase 4). Before going into Humans for Clinical Research adequate data from Animal and biologic studies (combinedly Pre-Clinical Studies) are sent to regulatory authorities to obtain approval for Clinical Trials.
Before going into technical details let me explain that these stages are designed to answer these basic questions :
Phase 1: What are the effects of the Drug/intervention on the human body? What's the best route of administration? Find a safe dose?
Phase 2: Does the intervention have the intended effect on Subjects? How does the intervention affect the human body?
Phase 3: How does the new intervention (or new use of an intervention) compare to the standard practice?
Phase 4: What are the effects of long-term or novel uses of an approved intervention? e.g. Withdrawal of NSAID Rofecoxib (Vioxx ®) from market mostly due to its increased risk of cerebrovascular events. Other examples are Cerivastatin , Troglitazone.
Classification of Clinical Trials :  Based on outcome :
| Treatment trials | | | | Prevention trials | e.g. Calcium preventing Eclampsia in pregnancy. | | | Screening & Early-detection trials | e.g. Chemotherapy patients receiving adjuvant drugs to reduce their nausea | | | Diagnostic trials | | | | Quality-of-life/supportive care trials | | | | Genetics Trials | | | Based on trial design : Clinical trials are mostly Randomized blinded trial based on the trial design, The other observational types are : Cohort Study, Cross-sectional study & Case-control study. | Randomized blinded study | Two groups selected at random and the intervention is blinded | | | Cohort study | A group is followed over time | | | Case-control study | Two groups selected based on presence or absence of disease or condition | | | Cross-sectional study | A group examined at one point of time | | Randomized Controlled trials : a carefuly and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomization so that precisely framed questions can be answered.
DRUG DEVELOPMENT PROCESS | | | | | | | | | | | | | | Laboratory / Pre clinical Testing | > | IND application filing with Regulatory Body | > | Phase 1 | > | Phase 2 | > | Phase 3 | > | File NDA or BLA with FDA | > | Marketing Approval | | | | | | | | | | | | | | | << CLINICAL TRIALS IN INDIA >>
<< CLINICAL DATA MANAGEMENT >>
<< MEDICAL CODING >>
<< 21 CFR PART 11 >>
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