Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.

With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency provided the agencies' perspectives on the challenges in ensuring data quality in novel clinical trial designs and the importance of the management and documentation of protocol deviations, sponsor oversight of clinical trials, and use of electronic source data, including electronic health records. This paper summarizes considerations of both agencies on these topics, along with case examples. This paper touches upon considerations when using real-world data to support regulatory decisions. It also discusses the impact of the coronavirus disease 2019 (COVID-19) pandemic on clinical trial conduct and underscores the importance of well-designed, resilient, and adaptable systems for GCP compliance and data integrity.

Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in clinical trials and to assure the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. The first joint GCP workshop of the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA-UK) was held in October 2018 and provided the agencies' perspectives on the importance of data quality management practices on data integrity. Regulatory perspectives on data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials were discussed. This paper summarizes considerations of both agencies on these topics, along with case examples.

The career trajectories of health care professionals practicing with permanent disabilities.

PURPOSE: The authors sought to generate insights and hypotheses about the professional experiences of registered nurses and physicians with self-identified disabilities to inform local and national policy conversations on supporting a diverse health care workforce. METHOD: In 2009-2010, the authors conducted in-depth interviews in person and over the telephone with a sample of licensed registered nurses and physicians across the country who self-identified as having a permanent disability. They coded the interview transcripts to identify key themes across the participants' responses. RESULTS: The authors interviewed 10 registered nurses and 10 physicians. Five novel and consistent themes emerged from the data analysis: (1) Living and working with a physical/sensory disability narrows the career choices and trajectories of nurses and physicians, (2) nurses and physicians struggle with decisions regarding whether to disclose and discuss their disabilities at work, (3) nurses and physicians rarely seek legally guaranteed workplace accommodations, instead viewing patient safety as a personal responsibility, (4) interpersonal interactions often reflect the institutional climate and set the tone for how welcome nurses and physicians feel at work, and (5) reactions to workplace disability-related challenges run an emotional spectrum from anger and grief to resilience and optimism. CONCLUSIONS: The responses revealed several missed opportunities for supporting health care professionals with disabilities in the workplace. These findings should inform the continuing debate regarding what defines "reasonable accommodation" and how to create a workplace that is welcoming for nurses and physicians with disabilities.

A physician team's experiences in community-based participatory research: insights into effective group collaborations.

BACKGROUND: Postdoctoral fellows from the Robert Wood Johnson Clinical Scholars Program are among a growing number of physician-researchers training in community-based participatory research (CBPR). These fellows are uniquely positioned to observe and evaluate CBPR training needs and the experience of collaboratively conducting a CBPR project. PURPOSE: To describe, from the perspective of physician-researchers, experiences in intragroup and intergroup collaborations while conducting CBPR. METHODS: During a 2-year fellowship, a group of seven fellows received 6 months of didactic training and then spent 18 months conducting a mentored CBPR project. The CBPR project was complemented by a 2-year facilitated leadership seminar, which allowed for reflection on intragroup (among fellows) and intergroup (fellows/community members) relationships throughout the CBPR process. RESULTS: Seven core principles of CBPR were found to apply to not only intergroup but also intragroup relationships: (1) building trust, (2) finding a shared interest, (3) power-sharing, (4) fostering co-learning and capacity building among partners, (5) building on existing strengths, (6) employing an iterative process, and (7) finding a balance between research and action for the mutual benefit of all partners. CONCLUSIONS: Establishing and maintaining relationships is at the core of CBPR. The development of intragroup relationships paralleled the development of intergroup relationships with community members. Applying the core principles of CBPR to the development of intragroup relationships provided experience that may have enhanced relationships with community partners. An a priori acknowledgement of the importance of relationships and the time needed to develop and manage those relationships may add to the CBPR training experience and assist in successfully executing collaborative projects.