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.

The Health of the World's Children: What Goes Around, Comes Around:

Abstract: Close to one-third of deaths worldwide are from diseases which are preventable or treatable with existing vaccines and drugs. Yet, half the world’s population, including some 1.5 billion children, lack regular access to essential therapeutic drugs. Due to the global economy, the ease and frequency of world travel, immigration, and the emergence of drug-resistant infectious diseases, the health problems of the developing world are now everyone’s problems. In order to ensure that our shared future is a healthy one, the world’s wealth and wisdom must be shared as well. One way in which the expenditure of resources in the developed world, in particular the United States, will result in a sharing of knowledge with the developing world is through the United States pediatric studies initiative, which will increase the availability of reliable prescribing information for drugs used in children. The ultimate goal is to make sure that drugs essential for the health needs of the world’s children are available, affordable, and properly used.

The single controlled trial: Industry survey indicates that implementation is still a work in progress

Abstract: The Food and Drug Administration Modernization Act of 1997 amended the standard of approval for effectiveness by providing that under certain circumstances, one adequate and well-controlled clinical investigation and confirmatory evidence would be sufficient. The standard of effectiveness has been a point of contention throughout the modern history of drug development and remains so today. With the imminent need to consider the reauthorization of the Prescription Drug User Fee Act, the implementation of the Food and Drug Administration Modernization Act of 1997 will also be open to discussion. In anticipation of the upcoming Congressional and public debate surrounding these laws, the Tufts Center for the Study of Drug Development conducted a survey of nearly 50 of the leading pharmaceutical and biotechnology firms in order to assess the level and manner of utilization of the single controlled trial at the outset of the Food and Drug Administration Modernization Act of 1997 to serve as a frame of reference for these discussions.

Impact of In-Pharmacy Education on Patients’ Knowledge and Attitudes About Clinical Trials:

Abstract: The lack of public awareness and understanding about clinical research has long hindered the efficiency and speed in recruiting patients to participate in clinical trials. Earlier research conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) examined whether pharmacists might be a viable channel to educate and engage the public about clinical research, and the results suggested that pharmacy-directed outreach and education are feasible. This study measured the impact of in-pharmacy education on patient comprehension and willingness to participate in clinical research. In collaboration with McKesson and its network of independent community pharmacies, CISCRP trained 32 pharmacists and provided them with educational materials to display and/or distribute at their pharmacies for a period of 2 to 3 months. Presurveys and postsurveys among 487 patients were conducted to gather baseline measures and to assess the impact of educational materials and in-pharmacy discussions. A postsurvey was also conducted among pharmacists. The results of the study show that patient discussions with their pharmacists and patient review of educational materials distributed through pharmacies positively impacted patient awareness, comprehension, and willingness to participate in clinical trials. Indeed, during the study period, 4% of patients who reviewed the materials chose to volunteer for clinical trials. Nearly all baseline measures of awareness and comprehension increased by 10 to 20 percentage points. Respondents were more interested in learning about clinical research after speaking with their pharmacists and reviewing educational materials, and 40% were more likely to recommend participation to a friend or family member.

A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration.

Abstract: The last two decades have witnessed the vigorous development of targeted cancer drugs and the potent therapeutic effects of these drugs have been validated by various true and surrogate end points. Overall survival (OS) and progression-free survival (PFS) outcomes were two important end points used in targeted cancer drugs clinical trials but investigation on which was rare as a consequence of inherent heterogeneity and complexity. Here, we present the review and analysis of OS and PFS outcomes of all targeted cancer drugs approved by the U.S. Food and Drug Administration (FDA) through December 31, 2019, in the setting of clinical studies. The targeted cancer drug directory was accessed via NCI website. The survival outcomes of those drugs in the setting of clinical trials were collected from publicly available Package Inserts and ClinicalTrials.gov. Median overall (OS) and progression-free survival (PFS) outcomes were summarized for targeted cancer drugs that were evaluated as monotherapies in clinical trials, contributions of targeted drugs to combination therapies in terms of survival benefit were analyzed, survival outcomes of FDA-approved first-line targeted therapies in different cancers were investigated, and the correlation between the absolute OS gain (ΔOS) and PFS gain (ΔPFS) as well as the hazard ratios for PFS (HRPFS) and OS (HROS) between comparative arms of available randomized clinical trials was evaluated. A total of 223 indications for 126 targeted cancer drugs have been approved by the FDA through December 31, 2019, among which 28 indications of 23 drugs have been approved for first-line therapies. Eighty indications for leukemia, lymphoma, and rare cancer types without survival data were excluded in the investigation of survival outcomes. For the remaining 143 indications, 99 were approved as monotherapies and 72 were approved as combination therapies. Among monotherapy subset, 18 of 72 (25%) indications with available OS outcomes have maximum median OS less than 12 months, 55 of 72 (76%) drug indications have maximum median OS less than 24 months, and 67 of 72 (93%) have maximum median OS less than 36 months. Regarding PFS, 38 of 88 (43%) drug indications have maximum median PFS less than 6 months, 69 of 88 (78%) drug indications have maximum median PFS less than 12 months, and 84 of 88 (95%) drug indications have maximum median PFS less than 24 months. The addition of targeted drugs to combination regimens under FDA’s approval provided notable survival benefit, but the median value of OS gain rate of the available combination regimens was lower than that of PFS. The univariate Spearman Rank correlation coefficient suggested a significant positive correlation between ΔOS and ΔPFS (R = 0.62) but a weak correlation between HROS and HRPFS (R = 0.11) in 46 randomized clinical trials that investigated contributions of targeted cancer drugs to combination therapies with available data. A moderate correlation between ΔOS and ΔPFS (R = 0.43) and a rather weak correlation between HROS and HRPFS (R = 0.07) were also found in other randomized clinical trials that included in our study with available data. The survival benefit provided by targeted cancer drugs varied a lot among cancer types. Though targeted cancer drugs showed improvements in both OS and PFS in approved combination regimens, the median value of OS gain rate was lower than that of PFS. As only weak correlation was found between HRPFS and HROS, the evidence supporting the use of PFS as a surrogate to OS in the setting of targeted cancer drugs might also be limited.