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20. OPTIMIZING THE PROCESS FOR ADOPTING DCT SOLUTIONS

Author

Getz, Kenneth

Subjects
Medical colleges -- Reports, Company personnel management, General interest, Health
Abstract

Study uncovers realistic goals in efforts to embrace decentralized clinical trials There have been a number of occurrences of late signaling that the adoption of decentralized clinical trial (DCT) technologies [...]

Published
2023

24. Assessing the net financial benefits of employing digital endpoints in clinical trials.

Author

DiMasi, Joseph A., Dirks, Abigail, Smith, Zachary, Valentine, Sarah, Goldsack, Jennifer C., Metcalfe, Thomas, Grewal, Upinder, Leyens, Lada, Conradi, Ute, Karlin, Daniel, Maloney, Lesley, Getz, Kenneth A., and Hartog, Bert

Subjects
CLINICAL trials, NET present value, DRUG development, INDUSTRIAL costs, RATE of return
Abstract

In the last few decades, developers of new drugs, biologics, and devices have increasingly leveraged digital health technologies (DHTs) to assess clinical trial digital endpoints. To our knowledge, a comprehensive assessment of the financial net benefits of digital endpoints in clinical trials has not been conducted. We obtained data from the Digital Medicine Society (DiMe) Library of Digital Endpoints and the US clinical trials registry, ClinicalTrials.gov. The benefit metrics are changes in trial phase duration and enrollment associated with the use of digital endpoints. The cost metric was obtained from an industry survey of the costs of including digital endpoints in clinical trials. We developed an expected net present value (eNPV) model of the cash flows for new drug development and commercialization to assess financial value. The value measure is the increment in eNPV that occurs when digital endpoints are employed. We also calculated a return on investment (ROI) as the ratio of the estimated increment in eNPV to the mean digital endpoint implementation cost. For phase II trials, the increase in eNPV varied from $2.2 million to $3.3 million, with ROIs between 32% and 48% per indication. The net benefits were substantially higher for phase III trials, with the increase in eNPV varying from $27 million to $40 million, with ROIs that were four to six times the investment. The use of digital endpoints in clinical trials can provide substantial extra value to sponsors developing new drugs, with high ROIs. [ABSTRACT FROM AUTHOR]

Published
2024
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25. ASSESSING THE NET FINANCIAL BENEFITS OF EMPLOYING DIGITAL ENDPOINTS IN CLINICAL TRIALS

Author

DiMasi, Joseph A., primary, Dirks, Abigail, additional, Smith, Zachary, additional, Valentine, Sarah, additional, Goldsack, Jennifer C., additional, Metcalfe, Thomas, additional, Grewal, Upinder, additional, Leyens, Lada, additional, Conradi, Ute, additional, Karlin, Daniel, additional, Maloney, Lesley, additional, Getz, Kenneth A., additional, and Hartog, Bert, additional

Published
2024
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34. Measuring Patient Satisfaction as a Primary Outcome: Reminding clinical research stakeholders to reprioritize routine assessment of patient satisfaction as a primary outcome measure in patient-centric activities

Author

Kim, Jennifer and Getz, Kenneth

Subjects
Medical research -- Measurement, Medicine, Experimental -- Measurement, Patient compliance -- Measurement, Patient satisfaction -- Measurement, Medical colleges -- Measurement, Clinical trials -- Measurement, General interest, Health
Abstract

During the past decade, there has been unprecedented focus on patient-centric initiatives in support of drug development planning and execution. The original intent of these initiatives was to amplify patient [...]

Published
2022

46. ROI and Rare Disease: Retooling the ‘Gene’ Value Machine.

Author

BLAUSTEIN, MARC and GETZ, KENNETH

Subjects
TREATMENT of rare diseases, GENE therapy, INTERPROFESSIONAL relations, INVESTMENTS, INVESTIGATIONAL drugs, PUBLIC sector, PRIVATE sector, PHARMACEUTICAL industry, ECONOMICS, DRUG approval, CONCEPTUAL structures, INDIVIDUALIZED medicine, DRUG development, QUALITY assurance, MANAGEMENT, MEDICAL care costs
Abstract

The article focuses on the challenges facing the biopharmaceutical industry in developing gene therapies for rare diseases. Topics include the high costs and limited patient populations for genetic treatments, strategies to optimize drug development and reduce risk, and the economic burden of these therapies on the healthcare system.

Published
2024

50. Establishing Consensus Understanding of the Barriers to Drug Development in Lupus

Author

Peña, Yaritza, Tse, Karin, Hanrahan, Leslie M., de Bruin, Annick, Morand, Eric F., and Getz, Kenneth

Abstract

Objective: Due to the extreme heterogeneity of lupus and the lack of consensus among stakeholders, pharmaceutical and biotechnology companies have had limited success in developing treatments for lupus. For this reason, the Lupus Foundation of America (LFA), researchers at the Center for the Study of Drug Development at Tufts University School of Medicine (Tufts CSDD) and an advisory committee of 13 international lupus experts collaborated to launch the Addressing Lupus Pillars for Health Advancement (ALPHA) project. Methods: To inform the ALPHA project, 17 in-depth interviews among lupus experts and a global survey among lupus drug development and clinical care professionals was conducted to identify, characterize, and prioritize fundamental barriers and validate findings. Results: The global survey received 127 responses from experts across 20 countries. Results of the in-depth interviews and the survey findings were consistent. Top barriers to developing new medical treatments for lupus included the lack of a clear definition of the disease with respondents identifying 30 autoimmune conditions that may be lupus-related; lack of predictive biomarkers; flaws in clinical trial designs; and a lack of reliable outcome measures. Conclusion: The study findings encourage drug development professionals to validate disease-specific measures and to identify if specific symptoms are caused by lupus. This original research also provides a methodology that can be applied to highly heterogenous diseases where low consensus on diagnosis and treatment exists among drug development and health professionals.

Published
2024
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