Kenneth A. Getz, MBA
Director of Sponsored Research Programs & Research Associate Professor
Area of Expertise
Pharmaceutical R&D management, protocol design complexity, R&D operating efficiency, R&D outsourcing and vendor management, global investigative site management, trends impacting the study conduct landscape, patient participation in clinical research.
|Faculty Summary||Recently Completed Research Projects|
|Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.||
Current Research Initiatives
- Evaluating the ROI of Patient Engagement -- Principal Investigator
- Assessing the Magnitude and Cost of Unused Protocol Data -- Principal Investigator
- Evaluating the Root Cause and Economic Impact of Drug Shortages -- Principal Investigator
- Benchmarking the Clinical Study Planning and Forecasting Process-- Principal Investigator
- Mapping the Global Investigative Site Landscape-- Principal Investigator
- Benchmarking Patient Recruitment and Retention Practices -- Principal Investigator
- Assessing the Accuracy and Completeness of Adverse Event Report Data -- Principal Investigator
- Getz K, Stergiopoulos S, Short M, Surgeon L, Krauss R, Pretorius S, Desmond J, Dunn D. The impact of protocol amendments on clinical trial performance and cost. Therapeutic Innovation & Regulatory Science. 2016; Published online before print February 22, 2016.
- Getz KA, Lamberti MJ. The unintended inefficiencies of outsourcing practice. Pharmaceutical Outsourcing. 2015;16(4):28-30.
- Stergiopoulos S, Getz K. Evaluating AE reporting of two off-patent biologics to inform future biosimilar naming and reporting practices. Drug Safety. 2015;38(8):687-692.
- Getz KA. Improving protocol design feasibility to drive drug development economics and performance. International Journal of Environmental Research and Public Health. 2014;11(5):5069-5080.
- Smed M, Getz KA. Site characteristics influencing the translation of clinical research into clinical practice [published online ahead of print March 13, 2014]. Therapeutic Innovation & Regulatory Science.
- Getz KA, Stergiopoulos S. Therapeutic area variability in the collection of data supporting protocol end points and objectives. Clinical Investigation. 2014;4(2):125-130.
- DiMasi JA, Kim J, Getz KA. The impact of collaborative and risk-sharing innovation approaches on clinical and regulatory cycle times. Therapeutic Innovation & Regulatory Science. 2014; [Published online before print February 5, 2014].
- Getz KA, Stergiopoulos S, Marlborough M, Whitehill J, Curran M, Kaitin, KI. Quantifying the magnitude and cost of collecting extraneous protocol data. American Journal of Therapeutics. 2013. [Published Ahead-of-Print; Last Updated: April 9, 2013]
- Getz KA. Assessing global CRA workload and utilization. ACRP Monitor. 2013;27(1):11-18.
- Getz KA, Kaitin KI. Open innovation: the new face of pharmaceutical research and development. Expert Review of Clinical Pharmacology. 2012;5(5):481-483.
- Getz KA, Stergiopoulos S, Kaitin KI. Evaluating the completeness and accuracy of MedWatch data. American Journal of Therapeutics. 2012. [Published Ahead-of-Print; Last Updated: January 24, 2013]
- Getz K, Hallinan Z, Simmons D, Brickman et al. Meeting the obligation to communicate clinical trial results to study volunteers. Expert Review of Clinical Pharmacology 2012;3: 149-156.
- Getz K. Transforming legacy R&D through open innovation. Monitor 2011;25: 17-21.
- Getz K, Campo R, Kaitin K. Variability in protocol design complexity by phase and therapeutic area. Drug Information Journal 2011;45:413-20.
- Simmons D, Chappell J, Getz K, Hallinan Z. Are pharmacists a viable channel for education about clinical trial participation? Drug Information Journal 2011;45:443-453.
- Lamberti M, Zuckerman R, Howe D, Shapiro L, Getz K. Factors influencing investigative site willingness and ability to participate in clinical trials. Drug Information Journal 2011;45:377-90.
- Getz K, Zuckerman R, Cropp A, Hindle A, Krauss R, Kaitin K. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Information Journal 2011;45:265-75.
- Zuckerman R, Getz K, Kaitin K. A new mechanism for tracking publicly available study volunteer demographics. Drug Information Journal 2011;45:55-64.
- Getz K, Vogel J. Successful outsourcing -- Tracking global CRO usage. Applied Clinical Trials 2009;18:42-50.
- Getz K, Zuckerman R, DiMasi J, Kaitin, K. Drug development portfolio and spending practices after mergers and acquisitions. Drug Information Journal 2009; 43:493-500.
- Cohen J, Faden L, Getz K. Mapping biopharmaceutical innovation and diffusion: how the second translational block (T2) shapes drug diffusion. The Open Pharmacology Journal 2008;2:89-106.
- Getz K, Wenger, J. Assessing the impact of protocol design change on clinical trial performance. American Journal of Therapeutics 2008; 15:449-456.
- Getz K, Faden, L. Racial disparities among clinical research investigators. American Journal of Therapeutics 2008;15:1075-2765.
- Sugarman J, Getz K. The cost of institutional review boards in academic medical centers. New England Journal of Medicine 2005; 352:1825-1857.
- Emanuel E, Sugarman J, Getz K. Oversight of human participant research: Identifying problems to evaluate reform proposals. Annals of Internal Medicine 2004;141:282-291.
- Sung N, Crowley W, Genel M, Salber P, Sandy L, Sherwood S, Catanese V, Tilson H, Getz K, Larson E et al. Central challenges facing the national clinical research enterprise. Journal of the American Medical Association 2003; 289: 1278-1287.
- Getz K, De Bruin A. Breaking the development speed barrier: Assessing successful practices of the fastest drug development companies. Drug Information Journal 2000; 34:725-736.
- Getz K, Vogel J. Achieving results with CROs: Their evolving role in clinical development. Applied Clinical Trials 1995; 4: 2-6.
- Getz K, Fisher S, Brookman S. Managing research centers as a portfolio of strategic resources. Drug Information Journal 1995; 29:551-562.
Board Memberships and Affiliations
- Contemporary Clinical Trials, Editorial Board, 2003 – 2011
- Research Practitioner, Editorial Board, 2004 – 2010
- Drug Information Journal, Editorial Board, 2005 – present
- Pharmaceutical Medicine, Editorial Board, 2011 - present
Boards and Committees
- Member, Clinical Research Roundtable, Institute of Medicine, National Academy of Sciences (2000-04)
- Chair, Subcommittee Examining Clinical Research Operating Costs, Institute of Medicine (2002-03)
- Member, Consortium to Examine Clinical Research Ethics, Johns Hopkins University and the Doris Duke Charitable Foundation (2002-06)
- Osher Institute Leadership Council, Harvard Medical School (2004-06)
- Founder and Board Chair, the Center for Information and Study on Clinical Research Participation (since 2004)
- Executive Board, Clinical Trials Transformation Initiative, Food and Drug Administration (FDA) and Duke University Medical School (since 2008)
- Owner and Chairman, CenterWatch LLC. (since 2010)
- Empirical Advisory Group, Presidential Commission for the Study of Bioethical Issues (2011)
- Secondary faculty appointment, Tufts CTSI (2015)
- Board of Directors, WCG Foundation (2016)