Year: 2009
Type: article
Abstract: Steady growth in the clinical/translational research enterprise at the University of Michigan Blood and Marrow Transplant Program necessitated institution of improvements in trial design and implementation. Several novel practices have been developed to facilitate a shortened timeline to enrollment for the first patient on trial, improve protocol compliance, and increase trial accrual. To improve protocol compliance, protocols were closely aligned with current program clinical practice guidelines (CPG) whenever such alignment did not impact the objectives of the protocol. To achieve this, protocols were reviewed by members from key job families such as Pre-Transplant Nurse Coordinators, Data Management and Research Nursing prior to protocol submission for Scientific Review and the IRB resulting in reduced protocol amendments and improved protocol compliance. Other strategies to improve protocol compliance were initiated. Single page protocol “Fast Facts” provide staff with an easy reference for important protocol points and highlight variations from program CPG. Post-transplant checklists outline protocol required observations and scheduling of necessary tests/appointments with follow up care. One page study summaries identify eligibility criteria, study objectives, treatment plan and required follow up. Responsibility lists are developed to clearly delineate each team member's role as it relates to the protocol. All study related materials are available via a website developed specifically for this purpose. Prior to patient enrollment, an internal site-initiation meeting is held by the principal investigator for members of the transplant team. At this meeting the reference tools are shared among staff for review. Non-physician communication concerning protocol status and planned changes was improved by initiating scheduled meetings among job families including Pre-Transplant Nurse Coordinators, Data Management, Research Nursing, Inpatient Nursing and Physician Extenders. A monthly protocol accrual grid is provided to all transplant team members. Protocol leads in each group are identified to act as a resource to others in their job family. These improvements in practice are reflected in a program CPG chapter specific to protocol implementation which serves as a template for future protocols. In the course of restructuring this process we have experienced the validity of the old English proverb “Prior preparation prevents poor performance”.
Authors: S.K. Anuszkiewicz, J.E. Levine, D.M. Jones
Institution: University of Michigan
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,650
OpenAlex ID: W2052195484