Medical scientists and public health policy makers are increasingly concerned that the
scientific discoveries of the past generation are failing to be translated efficiently into …

The challenges of measuring the safety and efficacy of investigational drugs that target
chronic, difficult-to-treat or rare diseases in more narrowly defined patient subpopulations …

Importance Extenuating circumstances can trigger unplanned changes to randomized trials
and introduce methodological, ethical, feasibility, and analytical challenges that can …

Background: Recently, drug development companies have sought out patient feedback to
improve overall drug development. However, characterization of the overall impact and …

The oversight of research involving human participants is widely believed to be inadequate.
The US Congress, national commissions, the Department of Health and Human Services …

Although it is widely acknowledged that protocol design plays a crucial role in the success of
clinical research studies, how protocols have changed over time and the impact of these …

Protocol design complexity has increased substantially during the past decade and this in
turn has adversely impacted drug development economics and performance. This article …

Background: While patient groups, regulators, and sponsors are increasingly considering
engaging with patients in the design and conduct of clinical development programs …

Importance Effective, continuous improvement in patient engagement depends on an
intimate understanding of public and patient perceptions and experiences in clinical …

Drug development companies frequently amend finalized clinical trial protocols. Yet the
incidence, causes, and impact of protocol amendments have never been quantified. Tufts …