Responsible conduct of research: Preparedness for times of crisis.

A live, virtual conference, "Driving Responsible Conduct of Research during a Pandemic," was held in April 2021, 13 months after the COVID-19 pandemic fundamentally altered the conduct of clinical research across the USA. New York was an early epicenter of the US pandemic, highlighting preexisting problems in clinical research and allowing us to assess lessons learned and to identify best practices for the future. Risks and opportunities were categorized broadly into three areas, protecting the welfare and safety of human subjects, ensuring trust in science and medicine, and implementing efficient, ethical, and compliant clinical research. Analysis of conference proceedings, and recent publications, shows a need for preparedness that is more effective, robust partnerships, and organizational systems and standards to strengthen the ethical and responsible conduct of research.

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

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.

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

BACKGROUND: Good clinical practice (GCP) training is the industry expectation for ensuring quality conduct of registrational clinical trials. However, concerns exist 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 quality conduct of clinical trials. Data were examined using applied thematic analysis. 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 but also 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 perceived relevance of GCP training. CONCLUSION: Our findings indicate that although investigators and sponsors recognize that GCP training addresses tasks critical to the quality conduct of clinical trials, the need for significant improvement in the design, content, and presentation of GCP training remains.

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency.

Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor's responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions.

Practically speaking: rethinking hand hygiene improvement programs in health care settings.

BACKGROUND: Hand hygiene is widely recognized as the single most effective means of reducing health care-associated infections. Implementing a credible hand hygiene program and maintaining high compliance among staff is both expected and required of hospitals. However, beyond general guidelines, few resources are available for establishing an institution-wide hand hygiene program that is both successful and sustainable over the long term. METHODS: Beginning in 2008, we completely overhauled the approach to hand hygiene at our institution. We created small teams consisting of a representative from Quality Assessment, an Infection Prevention Practitioner, and staff from a particular unit. Teams began by discussing the current barriers to hand hygiene success. They then set their own goals for hand hygiene compliance. Staff learned the World Health Organization (WHO) hand hygiene guidelines, which recently had been adopted as part of hospital infection prevention policy. Using the WHO guidelines, teams diagrammed detailed workflows for several of their most common patient care tasks. Wherever hand hygiene was indicated, the workflow was marked with a number corresponding to one or more of the WHO's "5 moments for hand hygiene." At the end of the 12-week period, staff members were trained to observe each other and began officially collecting and submitting data to Infection Prevention. RESULTS: Between 2006 and 2008, our average institutional hand hygiene compliance held steady at 60%-70%. After the new program was launched in 2008, compliance reached 97% and has been maintained at this level ever since. In addition to the 19 areas of the hospital that were observed previously, 15 ambulatory facilities and 5 regional sites are now included in the data. CONCLUSION: This article describes a novel approach to measuring, monitoring, and ultimately increasing hand hygiene compliance at our hospital. Our objective is to provide concrete, practical strategies for other institutions faced with the challenge of building or revamping their own hand hygiene programs.