INNOVATIONS in CLINICAL TRIALS

Clinical trials basically involves in  three or four steps:

  • Phase I trials: usually in healthy volunteers, determine safety and dosing.
  • Phase II trials: are used to get an initial reading of efficacy and further explore safety in small numbers of patients having the disease targeted by the NCE.
  • Phase III trials: are large, pivotal trials to determine safety and efficacy in sufficiently large numbers of patients with the targeted disease.
  • Phase IV: trials are post-approval trials that are sometimes a condition attached by the FDA, also known as post-market surveillance studies.

The procedure of defining characteristics of the drug does not stop once an NCE begins human clinical trials. In addition to the tests required to move a novel drug into the clinic for the first time, that manufactures must ensure that any long-term or chronic toxicities are well-defined, including effects on systems not previously monitored. They must also test the compound for its potential to cause cancer .

  • Preclinical and Clinical trails
  • Patient Centric Clinical Trials
  • Case reports in clinical trials
  • Pragmatic Randomized Clinical Trials
  • Field Trials
  • Bioethical issues in pharmacoepidemiologic research

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