scholarly journals Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors

2019 ◽  
Vol 15 (12) ◽  
pp. e1050-e1065 ◽  
Author(s):  
Kathryn F. Mileham ◽  
Caroline Schenkel ◽  
Meredith K. Chuk ◽  
Andrea Buchmeier ◽  
Raymond P. Perez ◽  
...  
Keyword(s):  
Adverse Event ◽  
Case Studies ◽  
Drug Safety ◽  
Decision Aid ◽  
Small Sample ◽  
Research Staff ◽  
Convenience Sample ◽  
New Drug ◽  
Safety Signals

PURPOSE: Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational drugs. Such errors can contribute to high volumes of uninformative investigational new drug safety reports that sponsors submit to the US Food and Drug Administration and participating investigators, which strain resources and impede the detection of valid safety signals. To improve the quality of serious AE (SAE) reporting by physician-investigators and research staff, ASCO developed and tested a Decision Aid. METHODS: A preliminary study with crossover design was conducted in a convenience sample. Physician-investigators and research staff were randomly assigned to receive case studies. Case studies were assessed for seriousness and attribution, first unassisted and then with the Decision Aid. Participants completed a feedback survey about the Decision Aid. Effectiveness of reporting and attribution are reported as odds ratios (ORs) with 95% CI. Power to detect associations was limited because of a small sample size. RESULTS: The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4). Most of the 29 participants reported that the Decision Aid was helpful (93%) and improved decision-making time (69%) and confidence in reporting (83%), and that they would use the Decision Aid in practice (83%). CONCLUSION: The Decision Aid shows promise as a method to improve the quality of SAE attribution, which may improve the detection of valid safety signals and reduce the administrative burden of uninformative investigational new drug safety reports. Study of the Decision Aid in a larger sample with analysis stratified by participant role and SAE reporting experience would further assess the tool’s impact.

Effectiveness of ASCO’s adverse event reporting decision aid: Results from an interventional study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3065-3065
Author(s):  
Kathryn Finch Mileham ◽  
Andrea D. Buchmeier ◽  
Meredith Kathleen Chuk ◽  
Courtney Davis ◽  
Anne Marie Forest ◽  
...  
Keyword(s):  
Adverse Event ◽  
Decision Aid ◽  
High Volume ◽  
Adverse Event Reporting ◽  
Investigational Drug ◽  
Interventional Study ◽  
Research Staff ◽  
To Receive ◽  
Safety Signals

3065 Background: Investigators often send adverse event (AE) reports to sponsors that are incorrectly categorized as serious or attributed to the investigational drug. Such errors contribute to a high volume of uninformative IND safety reports that sponsors submit to FDA and all participating investigators, straining stakeholder resources and impeding the detection of valid safety signals. To improve the quality of AE reporting, ASCO developed and tested a Decision Aid Tool (DAT). Methods: An interventional study with a cross-over design was conducted. Physician investigators and research staff were randomized to receive case studies. Cases were assessed for seriousness and attribution, first unassisted and then with the DAT. Participants completed a feedback survey. Effectiveness of reporting and attribution were assessed using logistic regression. Results are reported as odds ratios (OR) with 95% confidence intervals (CI). Results: Most of the 29 participants reported that the DAT was helpful (93%), improved their decision-making time (69%) and confidence in reporting (83%), and that they would use it in practice (83%). The DAT did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI: 0.31, 2.46) but it did significantly increase accuracy of attributing a serious AE to a drug (OR, 3.60; 95% CI: 1.15, 11.4). Conclusions: The DAT shows promise as a method to reduce errors in attribution of AEs, which may help to ensure the detection of valid safety signals. Many participants were experienced clinical trialists, and the DAT may show greater utility as an educational tool for novice investigators, research staff, and students.

scholarly journals Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

2017 ◽  
Vol 14 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Raymond Perez ◽  
Patrick Archdeacon ◽  
Nancy Roach ◽  
Robert Goodwin ◽  
Jonathan Jarow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Safety ◽  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Educational Materials ◽  
Research Staff ◽  
Safety Reporting ◽  
New Drug ◽  
Final Rule

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors’ adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. Conclusion: The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives.

Drug safety profiling for assessment of drug combinations in oncology

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15037-15037
Author(s):  
S. N. Voss ◽  
A. Czarnecki
Keyword(s):  
Ovarian Cancer ◽  
Drug Safety ◽  
Gastrointestinal Disorders ◽  
Safety Database ◽  
New Drug ◽  
Combination Treatments ◽  
Potential Safety ◽  
Drug Regimens ◽  
Safety Signals ◽  
System Organ

15037 Background: It is important to understand the safety profile (SP)/toxicity of new drug regimens in oncology. We compared SPs of gemcitabine (Gem) + carboplatin (Carbo) in NSCLC with Gem alone and in different combinations and also tested the methodology of drug safety profiling (DSP). Methods: Spontaneous cases for the period of 1995–2005 were reviewed on the Lilly Safety Database (LSD). DSP was used to evaluate differences in the SPs of several combinations: Gem+Carbo in NSCLC, Gem+Carbo in ovarian cancer, Gem+ cisplatin (Cis) in NSCLC, Gem+Carbo in all indications, and Gem regardless of treatment regimen, for all indications. Frequencies of adverse events (AEs) for all MedDRA System Organ Classes (SOCs) were used for each regimen. In addition, the MedDRA Preferred Terms (PTs) were reviewed to detect potential safety signals. The numbers of AEs in different SOCs were assessed as proportions of the total reports for the Gem combinations in the LSD. Results: With the exception of the Investigations SOC, the proportions of AEs for patients treated for NSCLC with Gem+Carbo were consistent with those for patients treated for NSCLC with Gem+Cis and with Gem for all indications. However, the frequency in the Investigations SOC was consistent with that reported for Gem+Carbo in all indications (14.2% v. 12.0%). A greater frequency of AEs was seen in the Gastrointestinal Disorders SOC for patients treated with Gem+Carbo for ovarian cancer compared to patients treated with Gem+Carbo for NSCLC. The review of individual PTs for Gem+Carbo did not reveal any safety signals. Conclusions: The SP of Gem+Carbo in NSCLC using DSP showed similar patterns to all other Gem combinations with only some differences due to the indication. DSP is a useful tool in assessing the new drug combination treatments in existing or new indications. [Table: see text]

Applying quantitative methods for detecting new drug safety signals in pharmacovigilance national database

2007 ◽  
Vol 16 (10) ◽  
pp. 1136-1140 ◽  
Author(s):  
Gloria Shalviri ◽  
Kazem Mohammad ◽  
Reza Majdzadeh ◽  
Kheirollah Gholami
Keyword(s):  
Drug Safety ◽  
Quantitative Methods ◽  
National Database ◽  
New Drug ◽  
Safety Signals

FDA's New Drug Safety Board Under Scrutiny

2005 ◽  
Vol 39 (3) ◽  
pp. 51
Author(s):  
JENNIFER SILVERMAN
Keyword(s):  
Drug Safety ◽  
New Drug

scholarly journals The effects of intensive home treatment on self-efficacy in patients recovering from a psychiatric crisis

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Ansam Barakat ◽  
Matthijs Blankers ◽  
Jurgen E Cornelis ◽  
Nick M Lommerse ◽  
Aartjan T F Beekman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Disorders ◽  
Self Efficacy ◽  
Psychotic Disorders ◽  
Rating Scale ◽  
Small Sample ◽  
Home Treatment ◽  
Differential Effects ◽  
Psychiatric Crisis

Abstract Background This study evaluated whether providing intensive home treatment (IHT) to patients experiencing a psychiatric crisis has more effect on self-efficacy when compared to care as usual (CAU). Self-efficacy is a psychological concept closely related to one of the aims of IHT. Additionally, differential effects on self-efficacy among patients with different mental disorders and associations between self-efficacy and symptomatic recovery or quality of life were examined. Methods Data stem from a Zelen double consent randomised controlled trial (RCT), which assesses the effects of IHT compared to CAU on patients who experienced a psychiatric crisis. Data were collected at baseline, 6 and 26 weeks follow-up. Self-efficacy was measured using the Mental Health Confidence Scale. The 5-dimensional EuroQol instrument and the Brief Psychiatric Rating Scale (BPRS) were used to measure quality of life and symptomatic recovery, respectively. We used linear mixed modelling to estimate the associations with self-efficacy. Results Data of 142 participants were used. Overall, no difference between IHT and CAU was found with respect to self-efficacy (B = − 0.08, SE = 0.15, p = 0.57), and self-efficacy did not change over the period of 26 weeks (B = − 0.01, SE = 0.12, t (103.95) = − 0.06, p = 0.95). However, differential effects on self-efficacy over time were found for patients with different mental disorders (F(8, 219.33) = 3.75, p < 0.001). Additionally, self-efficacy was strongly associated with symptomatic recovery (total BPRS B = − 0.10, SE = 0.02, p < 0.00) and quality of life (B = 0.14, SE = 0.01, p < 0.001). Conclusions Although self-efficacy was associated with symptomatic recovery and quality of life, IHT does not have a supplementary effect on self-efficacy when compared to CAU. This result raises the question whether, and how, crisis care could be adapted to enhance self-efficacy, keeping in mind the development of self-efficacy in depressive, bipolar, personality, and schizophrenia spectrum and other psychotic disorders. The findings should be considered with some caution. This study lacked sufficient power to test small changes in self-efficacy and some mental disorders had a small sample size. Trial registration This trial is registered at Trialregister.nl, number NL6020.

scholarly journals Quality of life in primary sclerosing cholangitis: a systematic review

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Elena Marcus ◽  
Paddy Stone ◽  
Anna-Maria Krooupa ◽  
Douglas Thorburn ◽  
Bella Vivat
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Clinical Research ◽  
Disease Progression ◽  
Primary Sclerosing Cholangitis ◽  
Sclerosing Cholangitis ◽  
Small Sample ◽  
Limited Evidence ◽  
Research Studies

Abstract Background Primary sclerosing cholangitis (PSC) is a rare bile duct and liver disease which can considerably impact quality of life (QoL). As part of a project developing a measure of QoL for people with PSC, we conducted a systematic review with four review questions. The first of these questions overlaps with a recently published systematic review, so this paper reports on the last three of our initial four questions: (A) How does QoL in PSC compare with other groups?, (B) Which attributes/factors are associated with impaired QoL in PSC?, (C) Which interventions are effective in improving QoL in people with PSC?. Methods We systematically searched five databases from inception to 1 November 2020 and assessed the methodological quality of included studies using standard checklists. Results We identified 28 studies: 17 for (A), ten for (B), and nine for (C). Limited evidence was found for all review questions, with few studies included in each comparison, and small sample sizes. The limited evidence available indicated poorer QoL for people with PSC compared with healthy controls, but findings were mixed for comparisons with the general population. QoL outcomes in PSC were comparable to other chronic conditions. Itch, pain, jaundice, severity of inflammatory bowel disease, liver cirrhosis, and large-duct PSC were all associated with impaired QoL. No associations were found between QoL and PSC severity measured with surrogate markers of disease progression or one of three prognostic scoring systems. No interventions were found to improve QoL outcomes. Conclusion The limited findings from included studies suggest that markers of disease progression used in clinical trials may not reflect the experiences of people with PSC. This highlights the importance for clinical research studies to assess QoL alongside clinical and laboratory-based outcomes. A valid and responsive PSC-specific measure of QoL, to adequately capture all issues of importance to people with PSC, would therefore be helpful for clinical research studies.

scholarly journals On Examining the Quality of Spanish Translation in Telephone Surveys: A Novel Test-Retest Approach

2019 ◽  
Vol 8 (4) ◽  
pp. 691-705
Author(s):  
Robert P Agans ◽  
Quirina M Vallejos ◽  
Thad S Benefield
Keyword(s):  
Past Research ◽  
Population Based ◽  
Pilot Test ◽  
Spanish Translation ◽  
Convenience Sample ◽  
Single Item ◽  
Telephone Surveys ◽  
Survey Questions ◽  
Health Related

Abstract Past research has shown that commonly reported cultural group disparities in health-related indices may be attributable to culturally mediated differences in the interpretation of translated survey questions and response scales. This problem may be exacerbated when administering single-item survey questions, which typically lack the reliability seen in multi-item scales. We adapt the test-retest approach for single-item survey questions that have been translated from English into Spanish and demonstrate how to use this approach as a quick and efficient pilot test before fielding a major survey. Three retest conditions were implemented (English-Spanish, Spanish-English, and English-English) on a convenience sample (n = 109) of Latinos and non-Latinos where translated items were compared against an English-English condition that served as our control. Several items were flagged for investigation using this approach. Discussion centers on the utility of this approach for evaluating the Spanish translation of single-item questions in population-based surveys.

scholarly journals Estimated Incidence of Sugammadex-Induced Anaphylaxis Using the Korea Adverse Event Reporting System Database

2021 ◽  
Vol 10 (15) ◽  
pp. 3202
Author(s):  
Jae-Woo Ju ◽  
Nayoung Kim ◽  
Seong Mi Yang ◽  
Won Ho Kim ◽  
Ho-Jin Lee
Keyword(s):  
Risk Management ◽  
Adverse Event ◽  
General Anesthesia ◽  
Drug Safety ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Sales Volume ◽  
Event Reporting ◽  
Pharmacovigilance Database

We aimed to investigate the incidence of sugammadex-induced anaphylaxis in a large Korean population. We retrospectively investigated the incidence of sugammadex-induced anaphylaxis between 2013 and 2019 from the database of the Korea Institute of Drug Safety-Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS). We estimated the incidence of sugammadex-induced anaphylaxis from the KIDS-KAERS database, assuming that the reporting efficiency was 10%, 50%, and 100%, respectively. We also investigated its annual sales volume in Korea and assumed that the exposure to sugammadex was 95% of the estimated sales volume. During the study period, 1,401,630 sugammadex vials were sold, and 19 cases of sugammadex-induced anaphylaxis were identified in the KIDS-KAERS database. The estimated incidence of sugammadex-induced anaphylaxis was 0.0143%, 0.00279%, and 0.0014%, assuming a reporting efficiency of 10%, 50%, and 100%, respectively. All patients, except for one with a missing record, fully recovered after anaphylaxis. The incidence of sugammadex-induced anaphylaxis identified in the national pharmacovigilance database was lower than previously reported rates in other countries. Therefore, its use in general anesthesia should not be hindered by concerns about the resulting risk of anaphylaxis in Korea.

scholarly journals Community intervention strategies to reduce the impact of financial strain and promote financial well-being: a comprehensive rapid review

2021 ◽  
Vol 28 (1) ◽  
pp. 42-50
Author(s):  
Nicole M. Glenn ◽  
Lisa Allen Scott ◽  
Teree Hokanson ◽  
Karla Gustafson ◽  
Melissa A. Stoops ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Community Intervention ◽  
Well Being ◽  
Small Sample ◽  
Financial Strain ◽  
Rapid Review ◽  
Research Centre ◽  
Future Research ◽  
The Impact

Financial well-being describes when people feel able to meet their financial obligations, feel financially secure and are able to make choices that benefit their quality of life. Financial strain occurs when people are unable to pay their bills, feel stressed about money and experience negative impacts on their quality of life and health. In the face of the global economic repercussions of the COVID-19 pandemic, community-led approaches are required to address the setting-specific needs of residents and reduce the adverse impacts of widespread financial strain. To encourage evidence-informed best practices, a provincial health authority and community-engaged research centre collaborated to conduct a rapid review. We augmented the rapid review with an environmental scan and interviews. Our data focused on Western Canada and was collected prior to the pandemic (May–September 2019). We identified eight categories of community-led strategies to promote financial well-being: systems navigation and access; financial literacy and skills; emergency financial assistance; asset building; events and attractions; employment and educational support; transportation; and housing. We noted significant gaps in the evidence, including methodological limitations of the included studies (e.g. generalisability, small sample size), a lack of reporting on the mechanisms leading to the outcomes and evaluation of long-term impacts, sparse practice-based data on evaluation methods and outcomes, and limited intervention details in the published literature. Critically, few of the included interventions specifically targeted financial strain and/or well-being. We discuss the implications of these gaps in addition to possibilities and priorities for future research and practice. We also consider the results in relation to the COVID-19 pandemic and its economic consequences.

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