Publications

Now is the time to fix the clinical research workforce crisis

Freel SA, Snyder DC, Bastarache K, Jones CT, Marchant MB, Rowley LA, Sonstein SA, Lipworth KM, Landis SP. Now is the time to fix the clinical research workforce crisis. Clinical Trials. 2023;0(0). doi:10.1177/17407745231177885

The clinical and translational research enterprise is recognized by many as the “evidence generation system.” While there have been several calls to revolutionize this enterprise to more effectively deliver the fruits of biomedical science to patients and society, significant issues across the clinical research workforce are pervasive. Perhaps the most visible sign is the widening gap between supply and demand for competent staff. Underpinning this, is a perfect storm of complex issues. Now reaching crisis point, this problem is far bigger than a staffing issue and ultimately jeopardizes the “engine” of drug and device development. With the current perilous state of the workforce, proposed enterprise fixes are likely to languish far out of reach, given that even “business as usual” is under threat. In fact, a glaring disconnect is evident between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits. In this article, we provide a brief forensic analysis of the workforce problem and an initial indication of where solutions may lie.

Clinical Research Management: Complimentary Materials

The complementary materials in this book have been created based on years of teaching and working in the clinical research management field. The original book A CLINICAL TRIAL WORKBOOK: Material to Complement Research Education and Training Programs was published in 2016. The intent was to provide tools and resources to assist in the training and education of present and future professionals in the field. The materials in that book have been used in many different courses including ethical conduct of research, contracts and budgets, scientific review boards, clinical research operations, monitoring of clinical trials, leadership and project management.

Since 2016, we have received many requests for additional materials. This new book is a compilation of materials from the original book (many revised) and additional materials requested. Materials include multiple protocols (including medical device), consent forms (including an assent form), clinical trial study site and sponsor budgets, clinical trial agreements, data management materials, recruitment ads, case report forms (CRFs), and other study documents. This book includes a study site Business Plan. The Plan includes study roles, facility information, site background, equipments, staff backgrounds and qualifications, staff training program, pay rates and more. It can be used to create assignments and activities such as developing a study budget; determining feasibility of a site for a study based on qualifications, resources, and space; data management plans; recruitment plans and activities; CRFs; and more.

Feedback from faculty and trainers that have used the materials in the previous book include:

“Until I found this book, I struggled to find materials to use in my budget management course. I have used the protocol for students to develop clinical trial budgets. I look forward to the new book with its additional materials and site business plan to incorporate more activities in my course.”

“We have used the protocol to have students create CRFs for various visits. It is a practical, hands-on experience for them. They learn much more than they would by just reviewing a CRF.”

“I have included this book in my research ethics course for the past 3 years. The materials are relevant to human subject research and demonstrate how to be compliant and ethical with study documents. Students also review the documents in relation to FDA CFRs to determine if they are compliant and how they might be improved.”

Managing Clinical Trial Budgets & Contracts

This textbook is designed for use in clinical trial management and regulatory programs for courses covering budgeting for clinical trials and and clinical trial agreement review, negotiation and management. It provides the reader with a roadmap to building budgets and reviewing contracts. It provides a step-by-step process for creating a budget  and a comprehensive review of clinical trial agreements including definitions, clauses, contract terms and language, and applicable laws and regulations. The authors provide tips throughout the books and each chapter concludes with review questions and scenarios for application of knowledge.

Pfeiffer, JoAnn and Windshciegl, Marilyn with guest author Garhan, Hailey. (2021). LAD Custom Publishing, Inc. ISBN #: 9 780840 174000

A Practical Guide to Managing Clinical Trials

A comprehensive guide to conducting clinical trials. This textbook is designed clinical research management academic programs and for individuals working in research site operations. This user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and study close-out. Topics include staff roles and responsibilities, budget and contract review and management, subject study visits, data management, event reporting, research ethics, audits and inspections, consenting process, IRB oversight, FDA regulations and GCPs. 

Pfeiffer, JoAnn & Wells, Cris. (2016) CRC Press. ISBN: 978-1-138-19650-6 

Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

Sonstein, S.A., Samuels, E., Aldinger, C. et al. Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training. Ther Innov Regul Sci 56, 607–615 (2022). https://doi.org/10.1007/s43441-022-00395-z

https://link.springer.com/article/10.1007/s43441-022-00395-z

Incorporation of Competencies Related to Project Management and Updated Clinical Trial Technology Content into the Joint Taskforce Core Competency Framework for Clinical Research Professionals

Sonstein SA, Kim LP, Ichhpurani N, et al. Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals. Therapeutic Innovation & Regulatory Science. 2022/01/05 2022;56(1)doi:10.1007/s43441-021-00369-7

crm-analytical-report-final.docx 

The Competency of Clinical Research Coordinators: The Importance of Education and Experience

Hornung CA, Kerr J, Gluck W, Jones CT. The Competency of Clinical Research Coordinators: The Importance of Education and Experience. Original Paper. Therapeutic Innovation & Regulatory Science. 2021-06-29 2021:1-8. doi:doi:10.1007/s43441-021-00320-w

Navigating a career as a clinical research professional: Where to begin?

Kesling, B.*, Saunders, J.*, Jones, C., Neidecker, M. (2020, June). Navigating a career as a clinical research professional: Where to begin? Clinical Researcher. June 2020: 34(6). https://acrpnet.org/2020/06/09/navigating-a-career-as-a-clinical-research-professional-where-to-begin/

Key ePortfolio features and strategies for student success in a competency-based clinical research program

Jones, C.T., Tornwall, J., Plahovinsak, J., Fritter, J*., Neidecker, M.V. (2021) The use of ePortfolio as an academic evaluation tool for clinical research competencies. Currents in Pharmacy Teaching and Learning 13 (8).

A perspective on the current state of clinical research education and training

Bocchino, JM, Butler, J, Harper B. A perspective on the current state of clinical research education and training. Clin Researcher 2020 Nov, 34(8): 8-20.

  bocchino_clin-research-ed-and-training_editedgc_new-ref-1.pdf