Tufts Center for the Study of Drug Development

About: Tufts Center for the Study of Drug Development is a based out in . It is known for research contribution in the topics: Drug development & Clinical trial. The organization has 78 authors who have published 258 publications receiving 16047 citations.

Pharmacy Benefit Managers’ Role in Facilitating Medicare Beneficiary Access to Pharmaceutical Care

Abstract: This paper assesses the role that pharmacy benefit managers (PBMs) could play in facilitating improved Medicare beneficiary access to pharmaceutical care (which includes access to pharmaceuticals as well as disease management coverage) Based on a literature review and original survey results, PBMs currently facilitate access to pharmaceuticals for an estimated 26% of Medicare beneficiaries In the short term, with implementation of the Bush Administration’s prescription drug discount plan, or in the longer term, with the passage of Medicare prescription drug benefit legislation, PBMs could increase their presence in the Medicare market considerably

Mandatory comparator trials for therapeutically similar drugs: an assessment of the facts

Abstract: Legislative proposals intended to compel industry to perform comparator trials are currently under consideration as Congress begins discussions on the reauthorization of the Prescription Drug User Fee Act. The proposals vary from ones that simply mandate head-tohead trials by statute to those that would provide specific incentives, either positive ones such as extending periods of market protection or negative ones such as a prohibition on advertising until trials are done. Whereas the use of mandating head-to-head trials postapproval is open to debate, the more contentious scenario is one in which head-to-head trials are required preapproval. So far, that discussion has been driven primarily by presumption, perception, and rhetoric. What has been missing from the debate is a careful assessment of the realities of the research and development (R&D) environment and the marketplace for new medicines, the feasibility of actually conducting such trials, and how useful the data would be relative to the burden on industry and the US Food and Drug Administration (FDA). Before moving forward politically on this issue, a few facts should be brought to light. We attempt to provide answers to some of the questions pertinent to the debate.

FDA Reform: Setting the Stage for Efforts to Reform the Agency

Abstract: Efforts within Congress, the Executive Branch, and the Food and Drug Administration (FDA) itself to reform agency function reflect a serious commitment to improve the new drug development process in this country and speed patient access to important new medical therapies. In this report, various factors that provide the underpinnings of these FDA reform efforts are considered. Important considerations are the increasing time spent in clinical development for new drugs, the growing trend for United States-based firms to initiate Phase I clinical testing overseas, and the delayed marketing of new products in this country relative to other markets. The result has been several strategic themes that are integral to most of the major reform proposals currently under consideration.

Assessing the Scope and Predictors of Intentional Dose Non-adherence in Clinical Trials.

Abstract: Although there is broad agreement that the accurate estimation of non-adherence rates in clinical trials is essential to determining the dose–response relationship, treatment safety and efficacy effects, no accurate estimates have ever been produced This study used a novel platform combining artificial intelligence and virtual patient monitoring to identify and quantify the scope of unreported intentional non-adherence in clinical trials of new medical therapies Nearly 260,000 observations were drawn from a convenience sample of 2976 study volunteers participating in 23 clinical trials of psychiatric, neurological and neuromuscular diseases The results indicate that 4% of all confirmed doses were intentionally non-adherent, 48% of all study volunteers had at least one intentionally non-adherent dose and 5% of study volunteers were intentionally non-adherent for more than one-third of all doses required Several factors were associated with, and predictive of, unreported intentional non-adherence including clinical trial phase; clinical trial duration; geographic location where the study was conducted; and investigative site enrollment volume The findings also show that although the overall rate of intentional non-adherence does not change over the course of a clinical trial, study volunteers who deliberately chose not to take their first dose had a mean intentional non-adherence rate five times higher than that observed among those who were first dose adherent Implications of the study results are discussed

A New Mechanism for Tracking Publicly Available Study Volunteer Demographics.

Abstract: The importance of gathering and monitoring aggregate demographic data on the annual population of study volunteers in FDA-regulated clinical trials is widely acknowledged. To date, no formal mechanism exists to capture this information. The Tufts Center for the Study of Drug Development identified and tested a publicly available source of information on clinical trial participant data, NDA Reviews stored in the FDA’s drugs@FDA database, to determine its accuracy, reliability, and feasibility. Thirty-seven new drug applications approved between 2006 and 2008 were evaluated and compared with published sources of demographic data. The authors conclude that the approach described here—NDA review extraction—provides reasonably reliable and conservative estimates of study volunteer demographics and can serve as a useful baseline until Clinicaltrials.gov or other, more complete, public sources become available.