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EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials.

ABSTRACT: At a meeting of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force in December 2016, an international group of investigators from industry, academia, and regulatory agencies reviewed lessons learned from ongoing and planned prevention trials, which will help guide future clinical trials of AD treatments, particularly in the pre-clinical space. The Task Force discussed challenges that need to be addressed across all aspects of clinical trials, calling for innovation in recruitment and retention, infrastructure development, and the selection of outcome measures. While cognitive change provides a marker of disease progression across the disease continuum, there remains a need to identify the optimal assessment tools that provide clinically meaningful endpoints. Patient- and informant-reported assessments of cognition and function may be useful but present additional challenges. Imaging and other biomarkers are also essential to maximize the efficiency of and the information learned from clinical trials.

SUBMITTER: Aisen P

PROVIDER: S-EPMC5724787 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials.

Aisen P P Touchon J J Amariglio R R Andrieu S S Bateman R R Breitner J J Donohue M M Dunn B B Doody R R Fox N N Gauthier S S Grundman M M Hendrix S S Ho C C Isaac M M Raman R R Rosenberg P P Schindler R R Schneider L L Sperling R R Tariot P P Welsh-Bohmer K K Weiner M M Vellas B B

The journal of prevention of Alzheimer's disease 20170101 2

At a meeting of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force in December 2016, an international group of investigators from industry, academia, and regulatory agencies reviewed lessons learned from ongoing and planned prevention trials, which will help guide future clinical trials of AD treatments, particularly in the pre-clinical space. The Task Force discussed challenges that need to be addressed across all aspects of clinical trials, calling for innovation in recruitment ...[more]

PMID: 29186281

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Project description:BackgroundCOVID-19 has had a significant impact on the well-being and job performance of oncology professionals globally. The European Society for Medical Oncology (ESMO) Resilience Task Force collaboration set out to investigate and monitor well-being since COVID-19 in relation to work, lifestyle and support factors in oncology professionals 1 year on since the start of the pandemic.MethodsAn online, anonymous survey was conducted in February/March 2021 (Survey III). Key outcome variables included risk of poor well-being or distress (expanded Well-Being Index), feeling burnout (single item from expanded Well-Being Index), and job performance since COVID-19. Longitudinal analysis of responses to the series of three surveys since COVID-19 was carried out, and responses to job demands and resources questions were interrogated. SPSS V.26.0/V.27.0 and GraphPad Prism V9.0 were used for statistical analyses.ResultsResponses from 1269 participants from 104 countries were analysed in Survey III: 55% (n = 699/1269) female, 54% (n = 686/1269) >40 years, and 69% (n = 852/1230) of white ethnicity. There continues to be an increased risk of poor well-being or distress (n = 464/1169, 40%) and feeling burnout (n = 660/1169, 57%) compared with Survey I (25% and 38% respectively, P < 0.0001), despite improved job performance. Compared with the initial period of the pandemic, more participants report feeling overwhelmed with workload (45% versus 29%, P < 0.0001). There remain concerns about the negative impact of the pandemic on career development/training (43%), job security (37%). and international fellowship opportunities (76%). Alarmingly, 25% (n = 266/1086) are considering changing their future career with 38% (n = 100/266) contemplating leaving the profession.ConclusionOncology professionals continue to face increased job demands. There is now significant concern regarding potential attrition in the oncology workforce. National and international stakeholders must act immediately and work closely with oncology professionals to draw up future-proof recovery plans.

Project description:BackgroundType 2 diabetes mellitus is preventable through lifestyle intervention. Diabetes prevention programmes (DPPs) aim to deliver prevention-based behaviour change interventions to reduce incidence. Such programmes vary from usual primary care in terms of where, how, and by whom they are delivered. Implementation is therefore likely to face new commissioning, incentive and delivery challenges. We report on the implementation of a national DPP in NHS England, and identify lessons learned in addressing the implementation challenges.MethodsIn 2017/18, we conducted 20 semi-structured telephone interviews covering 16 sampled case sites with the designated lead(s) responsible for local implementation of the programme. Interviews explored the process of implementation, including organisation of the programme, expectations and attitudes to the programme, funding, target populations and referral and clinical pathways. We drew on constant comparative methods to analyse the data and generate over-arching themes. We complemented our qualitative data with a survey focused on variation in the financial incentives used across sites to ensure usual primary care services recruited patients to new providers.ResultsWe identified five over-arching areas of learning for implementing this large-scale programme: 1) managing new providers; 2) promoting awareness of services; 3) recruiting patients; 4) incentive payments; and 5) mechanisms for sharing learning. In general, tensions appeared to be caused by a lack of clear roles/responsibilities between hierarchical actors, and lack of communication. Both local sites and the national NHS coordination team gained experience through learning by doing. Initial tensions with roles and expectations have been worked out during implementation.ConclusionsImplementing a national disease prevention programme is a major task, and one that will be increasingly faced by health systems globally as they aim to adjust to demand pressures. We provide practical learning opportunities for the wider uptake and sustainability of prevention programmes. Future implementers might wish to define clear responsibilities for each actor prior to implementation, ensure early engagement with new providers, offer mechanisms/forums for sharing learning, generate evidence and provide advice on incentive payments, and prioritise public and professional awareness of the programme.

Dataset Information

EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials.

Publications

EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials.

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