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The desire to regulate: the wish to discover
1Center for the Study of Drug Development, Tufts University, Boston, Massachusetts.
Drugs Under Experimental and Clinical Research
|January 1, 1987
Summary
This paper explores motivations for post-registration research, including new drug uses and filling knowledge gaps. It outlines fundamental principles for conducting this essential research effectively.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Regulatory Science
Background:
- Post-registration research is crucial for understanding drug efficacy and safety in real-world settings.
- Established drugs may offer new therapeutic applications beyond their initial indications.
- Gaps in knowledge regarding drug performance and patient outcomes necessitate further investigation.
Purpose of the Study:
- To examine the driving forces behind post-registration research initiatives.
- To identify novel uses for existing pharmaceutical products.
- To establish core principles guiding post-registration drug studies.
Main Methods:
- Literature review of existing studies on post-registration research.
- Analysis of case studies on new drug indications.
- Synthesis of expert opinions on research principles.
Main Results:
- Key motivators include regulatory requirements, market expansion, and unmet clinical needs.
- Several established drugs show potential for new therapeutic applications.
- Identified critical information gaps in current drug knowledge.
Conclusions:
- Post-registration research is vital for optimizing drug utilization and patient safety.
- Fundamental principles should emphasize scientific rigor, ethical conduct, and collaborative approaches.
- Further research should focus on evidence generation for new drug uses and addressing knowledge deficits.