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.

New Insights into Study Volunteer Perceptions and Experiences to Inform Patient-Centric Clinical Trials

Abstract: Stakeholders in the clinical research enterprise have stepped up their efforts to place patients at the center of clinical research planning and execution. Among the many ways that patient-centric clinical research is progressing, clinical research professionals are partnering with patients to play

Is the increasing cost of treating rare diseases sustainable

Abstract: Historically, high costs associated with bringing a drug to market and limited potential for revenue discouraged sponsors from developing products for diseases impacting small numbers of patients. ...

Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations.

Abstract: Social media presents new challenges to the biopharmaceutical industry for conducting pharmacovigilance activities. The authors reviewed worldwide regulatory guidance documents related to monitoring of adverse events posted on social media sites and identified gaps in current regulatory definitions for pharmacovigilance. Points to consider for addressing these gaps are made to offer standards for industry consideration and a potential framework for guidance from global health authorities.

Availability of anticancer drugs in the United States, Europe, and Japan from 1960 through 1991

Abstract: Clinical Pharmacology & Therapeutics (1995) 58, 243–256; doi:

Fixing the paradigm for biopharmaceutical R&D: Where to start?

Abstract: The basic thesis of this paper is that the R&D sector of the new medicines' business is experiencing evolutionary stress. Due to the failure of the regulatory framework and applied sciences to keep pace with advances in discovery, there is a bottleneck in the development phase of R&D. While improved process may help, there are still problems related to the products themselves, such as the need to move from a population-based model of product development, in which one size fits all, to a more targeted approach based on specialty drugs for patient subpopulations. The old paradigm dominated by big pharma and blockbusters must evolve, in order for a new bio-pharmaceutical paradigm to emerge. Despite the challenge that the fates of the pharmaceutical and biotech sectors are currently intertwined, it may be the dark before the dawn that betokens real change.