How Do Researchers Transition from Preclinical to Clinical Research?
The transition from preclinical to clinical research involves several steps:
1. Investigational New Drug (IND) Application: Researchers must submit an IND application to regulatory authorities, such as the FDA in the United States, providing data from preclinical studies and a detailed plan for clinical trials.
2. Phase I Clinical Trials: These trials involve a small group of healthy volunteers or patients to assess the safety and dosage of the new treatment.
3. Phase II and III Clinical Trials: These larger trials evaluate the efficacy and side effects of the treatment in a broader patient population. Successful completion of these phases can lead to regulatory approval.
