DDT acceptance in the drug development and regulatory review process has previously been on a sponsor-by-sponsor, drug-by-drug basis. DDTs developed for specific drug applications are typically not publicly available. Drug sponsors seeking to use specific DDTs have typically developed enough data to justify its use only in that one setting. Generalized applicability of DDTs across varied drug development programs is often left undetermined thereby limiting an expanded use of the tool. Furthermore, development of a DDT may require a substantial investment of resources and time to develop sufficient data to justify generalized use of DDTs.
The DDT qualification process creates a collaborative setting where multiple interested parties may pool their resources and data to decrease cost, expedite drug development, and facilitate regulatory review. Increased public availability of qualified DDTs for specific contexts of use is anticipated to benefit the public health through
- increased availability of effective drugs,
- earlier access to medical therapies and
- an enhanced knowledge of the drug under development
