Final answer:
To start possible participation in a Phase 1 clinical trial, researchers must collect data from animal trials and submit an IND application to the FDA. If the therapy meets FDA standards for safety and effectiveness, it can advance to further stages of clinical development.
Step-by-step explanation:
To start possible participation in a Phase 1 clinical trial, the first step is for researchers to collect significant laboratory data from animal trials and submit an Investigational New Drug (IND) application to the FDA for review. Once the IND is approved, clinical trials involving human subjects can begin. During these trials, researchers collect data on the therapy's effectiveness and safety, and if it meets FDA standards, developers can submit a New Drug Application (NDA) for approval.