For companies still working on early-stage drug development programs, clinical trials may still be many years away. Yet, understanding the fundamentals of the future clinical program is critical for designing drug development that incorporates future clinical requirements. It is the clinical studies, after all, that will support the ultimate decision of regulatory agencies to allow, or not allow, the marketing of a new product. Early failures to consider clinical trial principles can easily derail an entire development program.
In October of 2021, the ICH adopted the final version of E8(R1) General Considerations for Clinical Studies. The first revision since the original E8 release in 1997, the R1 version presents four principal objectives.
- Describe principles that will protect patients and facilitate regulatory acceptance of clinical data.
- Provide guidance on incorporating quality into the design and conduct of clinical trials.
- Provide an overview of the study design elements critical to the success of each type of clinical study.
- Provide a guide to the many ICH efficacy documents
For pre-clinical companies, section 4 of E8(R1) makes the importance of incorporating an understanding of the rights, safety, and well-being of study participants into all aspects of drug and device development. The quality of the investigational product is of utmost importance and it is incumbent on the development team to understand the ultimate characterization requirements needed before clinical use. E8(R1) also emphasizes the importance of conducting proper non-clinical studies, including toxicology, carcinogenicity, and understanding the timing of these studies relative to clinical studies. General guidance on these non-clinical safety studies is further provided in ICH Guideline M3(R2).