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.

Estimated lifetime survival benefit of tumor treating fields and temozolomide for newly diagnosed glioblastoma patients.

Abstract: Aim To estimate the mean lifetime survival benefit, an essential component of health economic evaluations in oncology, of adding tumor treating fields (TTFields) to maintenance temozolomide (TMZ) for newly diagnosed glioblastoma patients. Methods We integrated EF-14 trial data with glioblastoma epidemiology data. The model provided for an evidence-based approach to estimate lifetime survival for the material number of EF-14 trial patients still alive at 5 years. Results & conclusion Patients treated with TTFields and TMZ had an incremental mean lifetime survival of 1.8 years (TTFields/TMZ: 4.2 vs TMZ alone: 2.4). Patients alive at year 2 after starting TTFields had a 20.7% probability of surviving to year 10. The results presented here provide the required incremental survival benefit necessary for a future assessment of the incremental cost-effectiveness of TTFields.

Global consensus building and prioritisation of fundamental lupus challenges: the ALPHA project.

Abstract: Objective Lupus is a complex, heterogeneous autoimmune disease that has yet to see significant progress towards more timely diagnosis, improved treatment options for short-term and long-term outcomes, and appropriate access to care. The Addressing Lupus Pillars for Health Advancement (ALPHA) project is the first step in establishing global consensus and developing concrete strategies to address the challenges limiting progress. Methods A Global Advisory Committee of 13 individuals guided the project and began barrier identification. Seventeen expert interviews were conducted to further characterise key barriers. Transcripts were analysed using Nvivo and a codebook was created containing a list of thematic ‘nodes’ (topics) and their descriptions. Findings were used to develop a final survey instrument that was fielded to a diverse, international stakeholder audience to achieve broad consensus. Results Expert interviews identified lupus heterogeneity as the primary barrier hindering advancement. Subsequent barriers were categorised into three areas: (1) Drug development. (2) Clinical care. (3) Access and value. The global survey received 127 completed responses from experts across 20 countries. Respondents identified barriers as high priority including the lack of biomarkers for clinical and drug development use, flawed clinical trial design, lack of access to clinicians familiar with lupus, and obstacles to effective management of lupus due to social determinants of care. Respondents also identified 30 autoimmune conditions that may be lupus-related based on overlapping features, shared autoantibodies and pathophysiology. Conclusions ALPHA is a comprehensive initiative to identify and prioritise the continuum of challenges facing people with lupus by engaging a global audience of lupus experts. It also explored views on lupus as a spectrum of related diseases. Conclusions from this effort provide a framework to generate actionable approaches to the identified high-priority barriers.

Role of follow-on drugs and indications on the WHO Essential Drug List

Abstract: Introduction: The World Health Organization's Essential Drug List (EDL) contains first-in-class drugs and subsequent class entrants (follow-on drugs) deemed necessary to combat diseases prevalent throughout the world, with a special emphasis on developing nations. The EDL also includes originally approved and follow-on indications. There are opposing views regarding the value of follow-on drugs and indications. Critics suggest many follow-on drugs and indications offer little or no benefit to patients. Advocates counter that follow-on drugs offer advantages in terms of improved effectiveness, compliance and patient satisfaction. Objective: In order to inform this debate on the value of follow-on drugs and indications we examined the numbers of follow-on drugs on the EDL and the extent to which follow-on indications are recommended. Methods: We identified all 312 drugs on the 14th edition of the EDL, omitting 72 non-pharmaceutical entities. For the 240 pharmaceutical entities we ascertained whether the Food and Drug Administration (FDA) had approved them, and, if so, when each was approved. We chose a validated therapeutic classification system - the United States Pharmacopeia's Model Guidelines for Medicare formulary management - in order to distinguish first-in-class and follow-on drugs on the EDL. Specifically, we selected the formulary key drug type as our benchmark therapeutic class. We assigned each EDL drug to a formulary key drug type. We defined first-in-class drugs as the first in each formulary key drug type, and follow-on drugs as all other drugs in each formulary key drug type. We identified follow-on indications by comparing WHO-listed indications with the original approved indication(s) by the FDA. Finally, we examined the therapeutic rating (priority vs. standard) given by the FDA to follow-on drugs on the EDL. Results: Sixty-three per cent of the EDL drugs were follow-ons; 15% of the indications were follow-on indications. Fourteen drugs were listed in multiple WHO (sub) groupings; and 49% of follow-on drugs were given a priority rating by the FDA. Conclusions: In light of the fact that the EDL only includes drugs and indications deemed essential, the large number of follow-on drugs, follow-on indications, and priority-rated follow-on drugs on the EDL suggest their importance. From a public policy perspective, it may prove counterproductive to erect hurdles that impede follow-on research and development.

Measuring the Impact of PatientEngagement and Patient Centricityin Clinical Research and Development

Abstract: Recently, drug development companies have sought out patient feedback to improve overall drug development. However, characterization of the overall impact and return on engaging with patients have not been determined. The Drug Information Association (DIA), the Tufts Center for the Study of Drug Development (Tufts CSDD), and 17 other stakeholder organizations collaborated on a study to (1) quantify and define patient-centric initiatives (PCIs) utilized in clinical research and development and (2) to define evidence-based metrics and performance indicators that demonstrate return on engagement (ROE) of specific PCIs. We conducted a literature review, industry surveys, and in-depth interviews to determine and measure the impact of adopted PCIs. We identified and defined 30 PCIs used to engage with patients. We analyzed 121 case studies and created a comprehensive list of metrics assessing overall return to the organization and to patients. Advocacy Group Support and Involvement, Conducting Patient Advisory Panels, and Focus Groups were examples of PCIs with the lowest cost and largest impact with respect to quality, speed, and impact on the patient relative to other PCIs. The results from the literature review and use cases provide drug development teams with evidence and insights to help facilitate the adoption of specific PCIs within their organization and to help select those initiatives that would provide the highest impact to patients and development organizations. It is also hoped that the biopharmaceutical industry will apply the standardized metrics in the toolkit to systematically assess the overall return on engagement.