2004N-0181 - Critical Path Initiative; Establishment of Docket
FDA Comment Number : EC32
Submitter : Mrs. Susan Krivacic Date & Time: 08/02/2004 07:08:38
Organization : PBG Consulting
Private Industry
Category :
Issue Areas/Comments
Comment Issues
1. Hurdle Identification. Please describe the product development issue, the nature of the evaluation tool that is out-of-date or absent, how this problem hinders product development, and how a solution would improve the product development process.
There are many hurdles that exist in the product development cycle. Some of the major hurdles facing sponsors in medical product development reside within the clinical development stage for a product. Namely, sponsors face issues that are 1) of a process nature and 2) also a lack of state-of ?the art technology that can be implemented on a grand scale. The industry (e.g. pharma, CROs, SMOs, investigative sites, and other vendors) would benefit greatly by streamlining some of its business processes and implementing technology tools on a large scale (not project by project). Although not all the hurdles the industry is facing can be addressed in this document, I will attempt to illuminate some important ones below:
1) Established and approved product development plans
2) Patient recruitment approaches, strategies, processes and screening tools
3) Investigator agreements and contracts
4) Budgets and contracts with CROs and vendors
5) Protocol outlines and CRF standardization
6) IRB streamling of processes and informed consent standardization