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Types and Phases of Clinical Trials

TYPES OF CLINICAL TRIALS

Clinical Trials belong to one of the following types:

A. Company Sponsored Trials: The company takes the ultimate responsibility for the initiation, management and financing of the study.

B. Investigator-Initiated Trials: Investigator-initiated Clinical Trials are studies whereby the Principal Investigator designs the trial protocol and is, legally, the owner of the study. Investigator- initiated trials are usually submitted as proposals to pharmaceutical companies for soliciting financial support.

C. Observational-Study Trials: Observational studies report associations (correlations) between treatments already used by participants and their health status or diseases.

 PHASES OF CLINICAL TRIALS

Below are the description of four phases of clinical trials as defined by the International Conference on Harmonization (ICH), Health Canada, and the U.S. Food and Drug Administration (FDA).

Phase I

The Phase 1 of clinical research studies constitute the first set of testing of a new drug into humans. They typically include studies grouped under Human Pharmacology. Phase 1 clinical research has non-therapeutic objectives and is therefore not usually used for treatment of a disease. They are conducted on a small group of healthy volunteer subjects or on certain types of patients (such as patients with mild hypertension). The participants often need to stay overnight at the trial center to be closely monitored and observed. However, drugs that are known to have a high potential of toxicity (such as cytotoxic drugs used in chemotherapy in cancer) are usually studied in patients.

The phase 1 of clinical trial design can be open, meaning that both researcher and subject may know the details of the treatment. Phase 1 studies can also be baseline controlled: there is an assessment of the volunteer before and after treatment. Randomization and blinding may also be used. In this case, there is a random allocation of the treatment, without the researcher and/or the subject knowing what treatment is being administered, which lead to more accurate results. The clinical trial design Phase 1 can involve:

(a) Estimation of Initial Safety and Tolerability is used to determine the tolerability of the dose range expected to be needed for later clinical studies and to determine the nature of adverse reactions that can be expected.

(b) Pharmacokinetics information is used to characterize the profile of the new drug about its absorption, distribution, metabolism, and excretion by the human body. Although predominant in Phase 1 of clinical trials, PK are studies throughout the trial, and other PK studies are carried during Phase 2, Phase 3 and even Phase 4.

(c) Assessment of Pharmacodynamics, to provide an early idea of the activity and the potential efficacy of the new drug. PD can also guide the dosage of the drugs in later studies.

(d) Early Measurements of Drug Activity. Although usually done in later phases, it is possible to carry preliminary studies about drug potential therapeutic benefit in Phase 1 of a clinical trial, as a secondary objective.

Phase II

Clinical research studies Phase 2 can be initiated after enough information has been collected from phase 1 and safety been confirmed. Their primary objectives are to explore therapeutic efficacy in patients. Phase 2 studies are used to evaluate how well the drug works, and also to collect additional safety data in a larger group of volunteers and patients. While early studies of Phase 2 may include baseline controlled, later studies of Phase 2 are usually randomized with a placebo control, to evaluate the efficacy of the new drug and its safety under specific conditions or indications.

In Phase 2, the therapy or the drug is usually administered on a relatively uniform patient population, and groups are larger than those of Phase 1. Subjects are closely monitored and information collected is important to determine the dose and treatment indications that will be used during Phase 3. More studies under Phase 2 may be used to assess potential study endpoints, therapeutic restrictions (such as simultaneous or concomitant medications) or target populations (such as mild versus severe disease) for further studies.

Phase III

Phase 3 studies in clinical trials complete the information needed for the actual drug marketing approval, and give the official product information. For a drug to be approved, it typically has to undergo at least two successful Phase 3 trials, showing that the drug is safe for humans use and its efficacy in the targeted population.

Phase 3 studies aim to confirm the therapeutic benefits of the new drug on the targeted population, and also to confirm previously collected evidence about drug safety. Additional Phase 3 studies may be used to research the dose-response relationship or the drug's use in wider populations, in different stages of disease, or in combination with another drug.

Phase 3 studies are done on large group patients and are randomized controlled multi-center trials. The size and the relatively lengthy duration of Phase 3 trials make them notably expensive and time-consuming. Phase 3 trials can be difficult to design and run, especially in therapies for chronic medical conditions. Trials involving extended exposure to the drug may be started in Phase 2 of the clinical trial.

Phase IV

Phase 4 studies are post-approval studies and include therapeutic use type of studies. Clinical research studies Phase 4 are not mandatory for drugs and therapies approval, but can be important to optimize their use. Clinical trials Phase 4 can be used to refine the dosing recommendation of a drug or to identify rare side effects. Mortality and morbidity or epidemiological studies are other examples of a clinical trial Phase 4 studies. Some Phase 4 studies have led to the finding of harmful side effects, and the discontinuation or restriction of some drugs.

    

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