Blogs

May 18, 2015
Applied Clinical Trials
Many of us speak about the importance of clinical trial data quality and integrity, yet the lack of data quality standards and definitions introduces subjectivity risk in clinical trials.
May 14, 2015
Applied Clinical Trials
Type 2 diabetes mellitus is one of the Western world’s most common chronic conditions, with global prevalence increasing rapidly.
May 14, 2015
Applied Clinical Trials
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.
May 10, 2015
Applied Clinical Trials
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.
May 06, 2015
Applied Clinical Trials
Lexicon early on established an expanded access trial for those who screen-failed that would collect long-term safety data.
May 04, 2015
Applied Clinical Trials
TransCelerate recently launched the Placebo and Standard of Care Data Sharing Initiative in order to foster a data sharing infrastructure between TransCelerate member companies.
May 03, 2015
Applied Clinical Trials
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.
Apr 30, 2015
Applied Clinical 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.
Apr 26, 2015
Applied Clinical Trials
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).
Apr 26, 2015
Applied Clinical Trials
In the debate over patient-centric considerations in cancer care, one main focus has been the choice of proper endpoints for clinical trials.