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.

Assessing the impact of protocol design changes on clinical trial performance.

Abstract: 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 changes on clinical trial performance have never been quantified. To measure protocol design trends, the Tufts Center for the Study of Drug Development analyzed data on 10,038 unique phase 1-4 protocols conducted between 1999 and 2005. Tufts Center for the Study of Drug Development analyzed study conduct performance data on 57 individual phase 2 and 3 protocols administered at US-based investigative sites. The results of this study indicate that the number of unique procedures and the frequency of procedures per protocol have increased at the annual rate of 6.5% and 8.7%, respectively, during the time period measured. Investigative site work burden to administer each protocol increased at an even faster rate of 10.5% between 1999 and 2005. Additionally, during this time period, study conduct performance--that is, cycle time and patient recruitment and retention rates--worsened; and the number of protocol amendments, observed serious adverse events, and length of case report forms increased substantially. Implications of these results for simplifying protocol designs and minimizing negative effects on study conduct performance are discussed.

R&D Costs and Returns by Therapeutic Category

Abstract: Objectives: This study examines the degree to which therapeutic class accounts for variability in drug development costs. It also scrutinizes how sales levels vary across the associated therapeutic classes for those drugs that have reached the marketplace. Data and Methods: A stratified random sample of 68 investigational drugs that first entered clinical testing anywhere in the world from 1983 to 1994 was selected from the pipelines of 10 pharmaceutical firms. Clinical period cost data were obtained for these compounds by phase. The sample consisted both of drugs that failed in testing and drugs that obtained marketing approval. We grouped the drugs by therapeutic category. Clinical period costs per approved new drug (inclusive of failures) were obtained for the analgesic/anesthetic, antiinfective, cardiovascular, and central nervous system (CNS) therapeutic classes. Worldwide sales profiles for new drugs approved in the United States from 1990 to 1994 over a 20-year product life cycle were computed base...

Research and development costs for new drugs by therapeutic category. A study of the US pharmaceutical industry.

Abstract: The clinical period (i.e. clinical trial and long term animal testing) development costs of a random sample of new chemical entities (NCEs) were examined for differences in average cost. All of the NCEs studied were first tested in humans between 1970 and 1982, and were classified for the purposes of the study by therapeutic class. The costs of unsuccessful projects were included with those of projects that resulted in US marketing approval. Including income forgone from expending funds before returns are earned (‘time costs’), the capitalised (i.e. out-of-pocket plus time) clinical period costs per approved NCE were $US70, $US98, $USI03 and $US163 million (1993 dollars) for anti-infective, cardiovascular, neuropharmacological and nonsteroidal anti-inflammatory drugs, respectively. Combining the data for all therapeutic categories, the mean clinical period cost per approved NCE was $US93 million. Omitting costs associated with unsuccessful projects, the mean capitalised clinical period costs for approved NCEs ranged from $US7.1 million (for topical steroids) to $US66.7 million (for cardiovascular agents) [ 1993 dollars ]. The estimates of total clinical period costs per approved NCE depend on average out-of-pocket clinical phase costs, attrition rates across phases (i.e. the rates at which compounds drop out of active testing), the probability of marketing approval and deve lopment and regulatory review times. Phase attrition and approval rates are the most imponant sources of variability in total clinical period costs between therapeutic categories. Development cost estimates by therapeutic category did not correlate strongly with US sales in the fifth year of marketing. Cardiovascular NCEs had much higher than average sales revenues but clinical development costs for these drugs were only slightly above average. Conversely, nonsteroidal anti-inflammatory drugs attained average sales revenues but had much higher than average development costs.

The economics of follow-on drug research and development: trends in entry rates and the timing of development.

Abstract: Objectives: The development of so-called ‘me-too’, or ‘follow-on’, drugs by the pharmaceutical industry has been viewed by some as duplicative and wasteful, while others have argued that these drugs often provide needed therapeutic options and inject some price competition into the marketplace. This study examines data on the trends in the speed with which competitive entry has occurred in the pharmaceutical marketplace and the competitive nature of the industry’s development of these drugs. Data and methods: We examined data on the entry rates of drugs in a large number of therapeutic classes over time, as well as detailed survey information on the relative timing of the development of drugs in the classes. Classes were defined according to chemical structure or pharmacologic mode of action and similarity of clinical use. We determined average times to initial and subsequent entry in drug classes by period and examined the timing of development milestones achieved by what have turned out to be follow-on drugs in relation to the development and approval of the first drug in a class to be approved. Results: We found that the period of marketing exclusivity that the breakthrough drug in a new class enjoys has fallen dramatically over time (a median of 10.2 years in the 1970s to 1.2 years for the late 1990s). Approximately one-third of follow-on new drugs received a priority rating from the US FDA. The vast majority of the follow-on drugs for drug classes that were created in the last decade were in clinical development prior to the approval of the class breakthrough drug. Conclusions: The data suggest that entry barriers have fallen over time for new drug