Background Repurposing is a drug development strategy receiving heightened attention after the Food and Drug Administration granted emergency use authorization of several repurposed drugs to treat Covid-19. There remain knowledge gaps on the root causes, facilitators and barriers for repurposing. Method This systematic review used controlled vocabulary and free text terms to search ABI/Informa, Academic Search Premier, Business Source Complete, Cochrane Library, EconLit, Google Scholar, Ovid Embase, Ovid Medline, Pubmed, Scopus, and Web of Science Core Collection databases for the characteristics, reasons and example of companies deprioritizing development of promising drugs and barriers, facilitators and examples of successful re-purposing. Results We identified 11,814 articles, screened 5,976 for relevance, found 437 eligible for full text review, 115 of which were included in full analysis. Most articles (66%, 76/115) discussed why promising drugs are abandoned, with lack of efficacy or superiority to other therapies (n = 59), strategic business reasons (n = 35), safety problems (n = 28), research design decisions (n = 12), the complex nature of a studied disease or drug (n = 7) and regulatory bodies requiring more information (n = 2) among top reasons. Key barriers to repurposing include inadequate resources (n = 42), trial data access and transparency around abandoned compounds (n = 20) and expertise (n = 11). Additional barriers include uncertainty about the value of repurposing (n = 13), liability risks (n = 5) and intellectual property (IP) challenges (n = 26). Facilitators include the ability to form multi-partner collaborations (n = 38), access to compound databases and database screening tools (n = 32), regulatory modifications (n = 5) and tax incentives (n = 2). Conclusion Promising drugs are commonly shelved due to insufficient efficacy or superiority to alternate therapies, poor market prospects, and industry consolidation. Inadequate resources and data access and challenges negotiating IP are key barriers to repurposing reaching its full potential as a core approach in drug development. Multi-partner collaborations and the availability and use of compound databases and tax incentives are key facilitators for repurposing. More research is needed on the current value of repurposing in drug development and how to better facilitate resources to support it, where valuable, especially financial, staffing for out-licensing shelved products, and legal expertise to negotiate IP agreements in multi-partner collaborations. Trial registration The protocol was registered on Open Science Framework (https://osf.io/f634k/) as it was not eligible for registration on PROSPERO as the review did not focus on a health-related outcome.
This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of patient-provider interactions and they are often presented opportunities to learn about and engage in the informed consent process.
ObjectivesTo examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.DesignCross-sectional descriptive analysis.Setting and participantsNovel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.Main outcome measuresUsing established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.Results26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant. Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91–100) vs 59% (IQR 41–70), p<0.001), attributable to higher FDAAA compliance (median of 100% (IQR 88–100) vs 57% (0–100), p=0.01) and better data sharing (median of 100% (IQR 80–100) vs 20% (IQR 20–40), p<0.01). No significant differences were observed by company location or product type.ConclusionsIt was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Large companies are significantly more transparent than non-large companies, driven by better data sharing procedures and implementation of FDAAA trial reporting requirements. Greater research transparency is needed, particularly among non-large companies, to maximise the benefits of research for patient care and scientific innovation.
Aim This education‐focused study examined changes in nursing students' knowledge and attitudes towards responding to opioid‐involved overdoses following participation in trainings delivered using remote learning modalities. Design This pre‐post study examined learning outcomes among 17 nursing students. Methods Participants completed the Opioid Overdose Attitude Scale and Opioid Overdose Knowledge Scale to assess attitudes and knowledge, respectively. Trainings were delivered to two separate groups, one via virtual reality immersive video and another over video conferencing. Results Attitude scores increased by an average of 12.2 points and knowledge scores increased by 1.65 points. Within the virtual reality group, attitude scores increased by an average of 10 points, while no significant changes were observed in knowledge scores. The video conferencing group improved in both attitude and knowledge scores, by an average of 16.2 points and 2.1 points, respectively. Conclusions These hypothesis generating results illustrate the utility of remote learning approaches to deliver trainings, while maintaining social distance during the ongoing COVID‐19 pandemic.
Background: Repurposing is a drug development strategy receiving heightened attention after the FDA granted emergency use authorization of several repurposed drugs to treat Covid-19. There remain knowledge gaps on facilitators and barriers for repurposing and why promising drug candidates get shelved in the outset. Method: This systematic literature review used controlled vocabulary and free text terms to search ABI/Informa, Academic Search Premier, Business Source Complete, Cochrane Library, EconLit, Google Scholar, Ovid Embase, Ovid Medline, Pubmed, Scopus, and Web of Science Core Collection databases for the characteristics, reasons and example of companies deprioritizing development of promising drugs and barriers, facilitators and examples of successful re-purposing. Results: We identified 11,814 articles, screened 5,976 for relevance, found 437 eligible for full text review, 115 of which were included in full analysis. Most articles (66%, 76/115) discussed why promising drugs are abandoned, with lack of efficacy, or superiority to other therapies, for the studied indication (n=59), strategic business reasons (n=35), safety problems (n=28), research design decisions (n=12), the complex nature of a studied disease or drug (n=7) and regulatory bodies requiring more information (n=2) among the top. Repurposing barriers include inadequate resources (n=42), expertise (n=11), intellectual property challenges (n=26), poor data access (n=20), uncertainty about the value of repurposing (n=13), and liability risks (n=5). Repurposing facilitators include multi-partner collaborations (n=38), access to compound databases and corresponding screening tools (n=32), regulatory modifications (n=5), and tax incentives (n=2).Conclusion: Sponsors deprioritize development of promising drugs due to insufficient efficacy or superiority to other therapies for studied indications or populations, perceived market prospects, and industry consolidation. Inadequate resources and data access and challenges negotiating IP are key barriers needing reform for repurposing to reach its full potential as a core approach in drug development. Multi-partner collaborations and the creation, accessibility, and use of compound databases and tax incentives are key facilitators for repurposing. More research is needed on the current value of repurposing in drug development and how to better facilitate resources to support it, where valuable, especially financial, staffing for out-licensing shelved products, and legal expertise to negotiate IP agreements in multi-partner collaborations.Registration: The protocol was registered on Open Science Framework (https://osf.io/f634k/) as it was not eligible for registration on PROSPERO.
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