Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates

Abstract

The Clinical Trials Transformation Initiative (CTTI) Investigator Qualification Project addresses the need for a more efficient and effective means of identifying qualified clinical investigators and delegates. Selection of investigators and delegates who are qualified by training and experience to conduct clinical trials is essential to safeguarding protections for study participants and ensuring data quality and integrity. Sponsors generally document investigator qualification through training on the principles of good clinical practice (GCP), as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by regulatory authorities in the United States, Japan and the European Union. Although these GCP principles provide an important foundation for promoting the conduct of quality clinical trials, the industry standard "one-size-fits-all" GCP training may not fully prepare investigators and delegates for conducting quality clinical trials. Routine GCP training alone may not be sufficient to prepare an inexperienced member of a site team, while repeating such training is unlikely to enhance the qualifications of an experienced researcher. The CTTI project team used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions. CTTI provides recommendations on how to implement a more efficient and effective means of preparedness and qualification of investigators and delegates, determining whether a site team is a good fit for a particular protocol, and improving the quality of clinical trial conduct. States (US) Food and Drug Administration (FDA) regulations, trial sponsors are responsible for selecting investigators qualified by training and experience [1]. Sponsors generally document qualification of investigators and delegates through training on the principles of good clinical practice (GCP), as defined by the International Council for

Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK

“…Wider consultation at an earlier stage might helpfully scrutinise this assumption (including on issues like variation in normal lab values across trial centres [ 59 ]) and give greater reassurance about the chances of the trial recruiting to target and on time. It may also have benefits in terms of site training [ 60 ] or ensuring recruiters are comfortable with applying the eligibility criteria [ 44 ].…”

Clinical Trial Recruiters’ Experiences Working With Trial Eligibility Criteria: Results of an Exploratory, Cross-sectional, Online Survey

“…Wider consultation at an earlier stage might helpfully scrutinise this assumption (including on issues like variation in normal lab values across trial centres 59 ), and give greater reassurance about the chances of the trial recruiting to target and on time. It may also have bene ts in terms of site training 60 or ensuring recruiters are comfortable with applying the eligibility criteria. 44 It is possible that this nding is particularly affected by the self-selected nature of the survey sample, i.e.…”

More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant

“…Following the CTTI methodology [ 20 ], the findings contributed to the development of recommendations for stakeholders to improve GCP training to ensure the quality conduct of sponsored clinical trials [ 21 ]. By revising the methods and content of GCP training, we can move beyond qualification as a check-box activity and instead use GCP as a critical training tool to enhance the quality conduct of clinical trials.…”