There has been a significant decline of productivity in pharmaceutical R&D

• Many different reasons have been discussed, but little attention has been paid to the role of poor reproducibility of biomedical research in general

• There are often fundamental doubts about the credibility of research data leading to costly and often futile repetition of biomedical research studies

• One of the root causes for the reproducibility problem is the lack of a common quality standard for biomedical research

• There have been recent initiatives by the WHO and the FD&C Division of the American Society for Quality (ASQ) to address this issue

• The pharmaceutical industry needs to embrace these initiatives in order to reverse the negative productivity trend

