Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals.

In 2014, the Joint Task Force for Clinical Trial Competency (JTF) published its Core Competency Framework. The Framework has been utilized internationally by academic institutions, corporate entities, professional associations, educational and training programs, and regulatory agencies and integrated into their activities. The JTF has continually updated and expanded the scope of the Framework to reflect changes in the scientific understanding and methodology utilized in conducting clinical research. In 2019, representatives from the Drug Information Association Professional Development and Project Management Leadership Communities approached the JTF reflecting the importance of clinical project managers and the project management skill set to the clinical research enterprise. In response, the JTF created a Project Management Competency Task Force to define and document these core competencies with recommendations for their inclusion as a revision to the Framework 3.0. Two new specific competencies with related examples were incorporated into Revision 3.1 and expressed at the Basic, Skilled and Advanced levels. In addition, the wording of several existing competencies was modified, and related examples added to reflect the knowledge, skills, and attitudes of clinical project managers.

Update and trends on pharmacokinetic studies in patients with impaired renal function: practical insight into application of the FDA and EMA guidelines.

INTRODUCTION: The incidence of kidney dysfunction increases with age and is highly prevalent among patients with hypertension. Since many therapeutic compounds are primarily eliminated through the kidneys, impaired renal function can have negative consequences on drug disposition, efficacy and safety. Therefore, regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have issued detailed guidelines for new drug applications to determine posology requirements for patients with renal impairment. Areas covered: The current review highlights and contrasts agency requirements for pharmacokinetic renal impairment clinical studies. While many of the guidelines are similar among the two agencies, glomerular filtration rate (GFR) determination and reporting differ. Design considerations for a reduced, full or dialysis renal impairment study, as well as modifications to the FDA's draft guidance are discussed. Furthermore, scenarios where pharmacokinetic modelling analysis can benefit a drug development program are also reviewed. Moreover, practical solutions for patient recruitment challenges are addressed. Expert commentary: We summarize how 'one size does not fit all' for GFR assessment, and recommend when to use certain modalities. Finally, we highlight the need for the pharmaceutical industry to engage therapeutic experts to assist in protocol development for renal impairment studies, as these experts understand the nuances of this special population and recommended guidelines.