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.

Patient access to orphan drugs

Abstract: Background: The Orphan Drug Act of 1983 has been a success in terms of spurring development of orphan disease treatments. However, rising orphan drug spending coupled with increasing numbers of orp...

The effects of the prescription drug user fee act and the food and drug administration modernization act on the development and approval of therapeutic medicines

Abstract: The Prescription Drug User Fee Act of 1992 and the Food and Drug Administration Modernization Act of 1997 include provisions that were intended to increase the efficiency of the processes required for the clinical development and regulatory review of therapeutic medicines. The expected effects of the legislative acts were decreases in the time required for clinical development and product approval. Results from the analysis of the clinical (Investigational New Drug filing date to Biologic License Application [BLA]/New Drug Application [NDA] submission date) and approval (BLA/NDA submission date to approval date) phases for 54 applications for new biopharmaceutical products submitted to the Food and Drug Administration during fiscal years 1981 through 1998 indicate that while clinical phases consistently increased, the rate of increase slowed substantially for fiscal years 1997 through 1998. The approval phase for fiscal years 1997 through 1998, however, proved to be the shortest of any lime period examined. Taken together, the data from fiscal years 1997 through 1998 show the first decrease in the mean total length of time required for clinical development and approval of biopharmaceuticals. Similar analyses of data for 384 applications for new chemical entities indicate that mean clinical and approval phase lengths were shorter for fiscal years 1997 through 1998 than for any other time period included in the study. The results of this study suggest that the regulatory reforms associated with enactment of PDUFA and FDAMA have had a marked effect on the development and approval of therapeutic medicines.

An Analysis of Regulatory Review Times of Supplemental Indications for Already-Approved Drugs: 1989-1994

Abstract: Food and Drug Administration (FDA) review times for supplemental indications of already-approved new chemical entities (NCEs) were compared to the review times for their associated original indications. The data show that mean supplemental indication review time for NCEs that had supplemental indications approved by the FDA during 1989-1994 was 28.3 months, 3.7 months longer than the mean review time for the original indications associated with those supplemental indications. The hypothesis of a positive mean difference between a drug’s supplemental and original indication review times for the period 1989-1994 can be accepted (P = .044). Mean review time for the supplemental indications approved during 1993 and 1994 was 19.2 months, compared to 23.8 months for their associated original indications. Over this period, however, the mean difference between a drug’s supplemental and original indication review times did not differ from zero by a statistically significant amount. Regression analysis provided support for the hypothesis that supplemental indications that the FDA has identified as important were reviewed, other things being equal, more quickly than other approved follow-on uses. The review time distributions for important supplemental indications and for their associated original indications, though, did not differ by a statistically significant amount.

The Impact of Collaborative and Risk-Sharing Innovation Approaches on Clinical and Regulatory Cycle Times.

Abstract: During the past decade, high risk, cost, and inefficiency have driven pharmaceutical and biotechnology companies to enter into collaborative and shared innovation approaches, including mergers and acquisitions, joint development, and in-licensing. These approaches can interrupt the drug development process and affect program-level clinical and regulatory cycle times. To examine these potential impacts, detailed development histories were obtained for 289 new molecular and biologics entities that received FDA approval between 2000 and 2011. Approximately half the drugs analyzed had their clinical development activity interrupted by a collaborative or shared innovation approach, with in-licensing as the most common. The total duration (clinical plus approval phases) for interrupted development programs was 20% longer-an additional 14.8 months (median)-than that of uninterrupted development programs ( P < .05). Approval phase length differences between uninterrupted and interrupted programs were not statistically significant. The results of this study provide important benchmarks and new insights for portfolio planning, forecasting, and management.

Comparison of Prescription Drug Costs in the United States and the United Kingdom, Part 2: Proton Pump Inhibitors

Abstract: Study Objective To compare the annual cost of proton pump inhibitors (PPIs) in the United States and in the United Kingdom. Design Matched-cohort cost analysis. Data Sources U.K. General Practice Research Database (GPRD) and MarketScan Commercial Claims and Encounter Database, a large, U.S. self-insured medical claims database. Study Population We initially identified more than 1 million people in the GPRD who were younger than 65 years of age and who were prescribed at least one prescription drug in 2005. Each of these people was then matched by year of birth and sex to one person in the U.S. database. From the matched pool, we estimated that 280,000 people were aged 55–64 years from each country. Of these, an estimated 27,230 (9.7%) in the U.S. were prescribed a PPI compared with 22,560 (8.1%) in the U.K. After excluding patients who did not receive the PPI continuously or who switched PPIs during the year, there remained 11,292 people in the U.S. and 9923 in the U.K. who were prescribed a single PPI preparation continuously during 2005 (annual PPI users). Measurements and Main Results Annual drug costs were determined by random sampling. The estimated annual cost/patient in the U.S. ranged from $901 for generic omeprazole to $1485 for lansoprazole. In the U.K., the annual costs were similar, approximately $400 for each PPI, irrespective of whether the agents were available in generic formulation. The total estimated annual cost of PPIs for 2005 in this study group was $14 million in the U.S. compared with $4.1 million in the U.K. Conclusion The cost of continuous use of PPIs covered by private insurance companies in the U.S. in 2005 was more than 3 times the cost covered by the U.K. government. This result is consistent with the findings of an earlier study on relative costs of statins between the countries.