Potential Errors and Corrections in Early Phase Drug Development

Gerald L. Klein* and Roger Morgan

Potential Errors and Corrections in Early Phase Drug Development. Many foreign and small companies trying to enter the United States biopharmaceutical market make avoidable errors in their early clinical phase drug development and clinical trials.

They need to first understand the risks that they must endure with patent law, regulatory hurdles, the complexity and duration of the necessary clinical trials, and the large cost of drug development, which often necessitates raising substantial capital from investors.

If appropriate capital for these clinical studies must be raised, then the company must be able to clearly articulate a realistic expected return on investment to these individuals. So, they must also understand the market, its exclusivity, and the competition.

These and other risks and errors may be prevented by the use of an experienced product development team. Many of these errors could be avoid.
Is there an established clear regulatory track for approval? One must know how difficult and complex the regulatory hurdles will be. This sets the foundation for establishing the timelines and economic requirements for the entire product development.

Regulatory guidelines can often be vague and confusing. Academics understand basic and clinical science but that does not mean that they understand regulatory science. They frequently have had limited interactions with the regulatory agencies, mainly from a site perspective. Although many academics will be able to help with scientific and medical inclusion exclusion/criteria, laboratory, and other tests, they often suggest excessive unnecessary tests outside the need for regulatory approval.

Clin Trial Pract Open J. 2022; 5(1): 1-5. doi: 10.17140/CTPOJ-5-122