Introduction:

• Sponsor is an individual or organization that takes legal responsibilities for and initiates the clinical investigation
• Investigator is the individual who actually conducts clinical trial.

Steps

• Basic research
  • Discovery
  • Proof of concept
  • Therapeutic mechanism and pathway
  • Cell and disease interaction
• Preclinical studies
  • Animal studies to know efficacy and toxicity
  • Manufacturing: Scale up, validation and release criteria
• Phase 1
  • Testing product on healthy volunteers over wide variety of dose ranges
  • It is done to assess the different toxicities and establish dose range across which the desired therapeutic effect is seen.
• Phase 2
  • Group of patients with disease of interest are exposed to the drug
  • Drug is administered at lower doses
  • This is done to know whether the drug has therapeutic effect in “tolerable doses”
  • Best dosage is determined during this phase
• Phase 3
  • New drug is compared with standard of care therapy, to know which drug works better.
• Phase 4
  • Post marketing evaluation of drug, after it is approved for clinical use
  • Relies on the reports from the clinicians, to monitor for unexpected toxicity