Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products &tobacco, Robert Califf.
With the introduction of mobile health technologies in the field of healthcare, Sponsors and CROs are looking into mHealth to design patient centric clinical trials in order to reduce study visit costs and trial participation burden on patients.
There is nothing more disappointing for a pharmaceutical company than to place its bets on a specific molecule/compound in its pipeline and invest billions of dollars in development, only to have the drug fail in late phase trials.
Among the multiple proposals for stimulating drug development and revising regulatory processes, the 21st Century Cures initiative includes several provisions designed to streamline clinical research and the amount of data required to gain FDA approval of certain indications.
Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).