What is clinical research

All medicines sold in the USA must first be approved by the Food and Drug Administration (FDA). But how does the FDA judge if a new medicine can be sold? Well, the FDA first requires pharmaceutical companies and biotechnology companies to confirm their safety and efficacy in animals.

  • Safety (Are there any side-effects?)
  • Efficacy (Is the drug effective?)

If there is evidence for safety and efficacy in animal studies, then the FDA requires clinical research to be conducted in humans. Clinical research therefore refers to human studies to confirm the safety and efficacy of a new drug. The results of this research will be used to obtain a license from FDA to sell a new medicine.

Clinical research for most new medications progresses through the following phases.

This is the English text of the graphic on the Japanese homepage
Phase I: In this phase, the safety of the study drug is assessed in healthy volunteers by initially administering low doses of the drug. The doses are gradually increased in later studies based on safety data from previous studies.

Early Phase II: In this phase, studies are performed to assess the efficacy and safety of the drug in a small group of patients.

Late Phase II: In this phase, studies are performed to assess the dosing requirements, in other words, how much drug should be administered to patients?

Phase III: Phase III studies are performed to assess the efficacy and safety in a large group of patients.

Regulatory Submission

Marketing Approval

Market Launch of New Drug

  • When Members of IBERICA CSSG volunteer for a study, they are volunteering to participate in the Phase I studies discussed above.
  • The length of Phase I clinical studies varies depending on the particular investigational product or study design. Some studies may be completed within one day; however others may require the volunteers to stay for up to two weeks to complete the trial. (Declining a lengthy study will not disadvantage you from participating in other studies in the future.)
  • There are a variety of formulations that may be used in the studies that IBERICA CSSG members participate in, such as ointments, oral drugs, adhesive skin patches or injections.