The Clinical Trials Transformation Initiative: Methodology supporting the mission

Corneli, Amy; Hallinan, Zachary P.; Hamre, Gerrit; Perry, Brian D.; Goldsack, Jennifer C.; Calvert, Sara B.; Forrest, Annemarie

doi:10.1177/1740774518755054

Cited by 15 publications

(16 citation statements)

References 9 publications

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“…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].…”

Section: Discussionmentioning

confidence: 99%

More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant

Swezey

McGuire

Hurley

et al. 2020

Preprint

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Background: Good clinical practice (GCP) training is the industry standard for ensuring the quality conduct of registrational clinical trials. However, concerns have been raised about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. Methods: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure the quality conduct of clinical trials. We used applied thematic analysis to analyze the data. Results: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants’ health and safety. Respondents acknowledged that GCP principles address each of these critical tasks; however, they described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the relevance of GCP training to investigators and their delegates. Conclusion: Our findings indicate that although investigators and sponsors recognize that GCP training addresses critical tasks necessary to the quality conduct of clinical trials, they articulated the need for significant improvement in the design, content, and presentation of GCP training.

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Section: Discussionmentioning

confidence: 99%

More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant

Swezey

McGuire

Hurley

et al. 2020

Preprint

Self Cite

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“…CTTI projects utilize multistakeholder project teams that follow an evidence-based methodology to identify impediments to research, gather evidence to identify gaps and barriers, explore results by analyzing and interpreting findings, and finalize solutions by developing recommendations and tools [ 7 ]. The CTTI Pregnancy Testing in Clinical Trials Project Team comprised representatives from academia, the pharmaceutical industry, the FDA, and patient representatives and advocacy organizations ( https://www.ctti-clinicaltrials.org/projects/pregnancy-testing ).…”

Section: Methodsmentioning

confidence: 99%

“…The meeting utilized a combination of moderated full group and breakout group sessions utilizing prepared questions and open discussion ( https://www.ctti-clinicaltrials.org/files/pregnancytesting-meeting_agenda.pdf ). The project team then reconvened in monthly teleconferences to finalize project recommendations [ 7 ] based on the data gathered and discussions from the expert meeting.…”

Section: Methodsmentioning

confidence: 99%

Evidence-based pregnancy testing in clinical trials: Recommendations from a multi-stakeholder development process

et al. 2018

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Most clinical trials exclude pregnant women in order to avoid the possibility of adverse embryonic and/or fetal effects. Currently, there are no evidence-based guidelines regarding appropriate methods for identifying early pregnancy among research subjects. This lack of guidance results in wide variation in pregnancy testing plans, leading to the potential for inadequate protection against embryonic or fetal exposure in some cases and unnecessary burdens on research participants in others, as well as inefficiencies caused by disagreements among sponsors, investigators, and regulators. To address this issue, the Clinical Trials Transformation Initiative convened content experts and stakeholders to develop recommendations for pregnancy testing in clinical research based on currently available evidence. Recommendations included: 1) the study protocol should clearly state the rationale for pregnancy testing and the plan for handling positive and indeterminate tests; 2) protocols should include an assessment of the pregnancy testing plan advantages (reduced risk of embryo/fetal exposure) versus the burdens (participant burden, study team workload, costs); 3) protocols should assess the participant burdens regarding the likelihood of false negative and false positive results; 4) participant administered home pregnancy testing should be avoided in clinical trials; and 5) the consent process should describe the extent of knowledge about the study intervention’s potential risk to the embryo/fetus and the limitations and consequences of pregnancy testing. CTTI has also developed an online tool to help implement these recommendations.

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“…In addition to these themes, meeting attendees discussed solutions to inform the development of project recommendations and tools [11].…”

Section: Communication Is Key Early Communication Between Sites Spon-mentioning

confidence: 99%

“…After the project team determined that the evidence-gathering objectives had been met and no major gaps in evidence remained, the team followed a systematic development process to craft a series of project recommendations and resources for all clinical trial stakeholders [11]. As with all its projects, CTTI aimed to develop recommendations that are actionable, concise, consensus-driven, and easily accessible by an external audience.…”

Section: Development Of Recommendations and Resourcesmentioning

confidence: 99%

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

Bechtel¹,

Chuck

Forrest³

et al. 2020

Contemporary Clinical Trials

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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

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The Clinical Trials Transformation Initiative: Methodology supporting the mission

Cited by 15 publications

References 9 publications

More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant

More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant

Evidence-based pregnancy testing in clinical trials: Recommendations from a multi-stakeholder development process

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

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