Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.

BACKGROUND: The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes between FDA and EMA were never evaluated. This is the first analysis comparing the GCP inspection processes between the two agencies. METHODS: We examined and analyzed the key characteristics of the GCP inspection processes, including the geographical distribution, inspection types and timelines from application submission to final inspection reporting for marketing applications from September 2009 through December 2015. RESULTS: Fifty-five shared applications were included for analysis. For these applications, a total of 433 GCP inspections were conducted in 47 countries. Most clinical investigator (CI) inspections were conducted in regions outside of each agency's own regulatory jurisdiction, while most sponsor/contract research organization (CRO) inspections were conducted in the U.S. by both agencies. Twenty-eight shared applications included common sites inspected by both agencies. There were 15 joint inspections conducted for seven of these applications and the remaining applications had common sites inspected by both agencies at separate times. Of the joint inspections, 73% were conducted in the U.S and 20% in the E.U. The median time from submission of an application to generation of final inspection reports was 232 days for FDA and 204 days for EMA, with no significant differences noted among applications with and without common sites. CONCLUSION: The inspection processes and timelines between the two agencies were similar, providing support for continued FDA-EMA GCP collaboration.

Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

BACKGROUND: The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported. METHODS: We identified common inspections of clinical investigators, sponsors, and contract research organizations conducted by both agencies in support of marketing applications that had the same trial data submitted between 2009 and 2015. We grouped inspection findings into deficiency areas. We reviewed and compared these findings and calculated concordance rate for each deficiency area. RESULTS: Twenty-six clinical investigator sites and 23 sponsors/contract research organizations were inspected by both agencies in support of 31 marketing applications during this period. For FDA, the most common GCP findings were deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management issues for sponsor/contract research organization inspections. For EMA, deficiencies related to Documentation (including Trial Master File) were the most common findings for both clinical investigator and sponsor/contract research organization inspections. There was high concordance, of approximately 90%, for deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management for sponsor/contract research organization inspections between the two agencies. There was a concordance rate of about 70% for Documentation deficiencies for both clinical investigator and sponsor/contract research organization GCP inspections. CONCLUSION: GCP inspection findings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued FDA-EMA GCP collaboration.

In the company of my sisters: sister circles as an anxiety intervention for professional African American women.

BACKGROUND: Sister circles have been used within African American communities to raise awareness about physical health. The possibility exists that sister circles could be used to educate and teach women strategies about managing anxiety and panic. In this paper we examine professional Black women's conceptualization of panic attacks and other related anxiety issues. Then, we explore the feasibility of sister circles as a psycho-educational anxiety intervention for African American professional women. METHODS: Four focus groups (n=37) were conducted. Focus group interviews were transcribed and were coded into three categories: (a) a major theme; (b) a minor theme; or (c) an off-topic comment. Specifically, we generate information regarding the key content and research components of a sister circle for African American female professionals. RESULTS: Focus group members saw a distinct difference between anxiety and panic. The number of African American women who experienced was seen as low. Women felt sister circles were a nice vehicle for helping African American women manage their anxiety and panic. Confidentially was a key component. Sister circles for anxiety and panic were seen as a natural outgrowth of African American women's professional networks. LIMITATIONS: Limited data were collected on participant's anxiety levels. CONCLUSIONS: Overall, sister circles were seen as feasible interventions for African American professional women. The data from the focus groups were used to enhance the development of a sister circle intervention for anxious professional African American women.