National landscape assessment of academic medical center support for expanded access to investigational products.

Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic medical centers (AMCs) are likely to encounter EA requests, but it is unknown what support is available at these institutions for physicians seeking EA for patients. METHODS: A landscape assessment was conducted at AMCs, focused on those within the Clinical and Translational Science Awards (CTSA) consortium. RESULTS: Forty-seven responses were evaluated including 42 CTSA hubs. The large majority (43 of 47 respondents) reported using single-patient EA, while 37 reported multi-patient industry sponsored EA and 37 reported multi-patient investigator-initiated EA. Only half reported central tracking of EA requests. Support was available at 89% of sites for single-patient EA but less often for multi-patient EA. Types of support varied and were focused largely on the initial submission to the FDA. CONCLUSION: Use of and support for EA is widespread at AMCs, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection.

Evaluating mindfulness training for medical and PhD nursing students.

BACKGROUND: it is recognised that mindfulness training can positively impact holistic wellbeing and can improve mood, focus and resilience. Health service students often experience high levels of psychological morbidity. Engaging in mindfulness techniques may positively impact the psychological wellbeing of healthcare students. This is of vital importance to ensure optimum learning for healthcare practice with its associated challenges. METHOD: an evaluation was conducted with medical students (n=4) and PhD nursing students (n=6), who took part in a mindfulness-based workshop, followed by five weekly 30-minute sessions of mindfulness training, including a 15-minute meditation exercise. Data collection was carried out at baseline and post intervention, followed by a focus group discussion to elucidate qualitative experiences. RESULTS: significant findings were identified with respect to cognitive mindfulness scores (P=0.02) and resilience (P=0.04). DISCUSSION: data reflected three themes: the impact of mindfulness and maintaining practice, improvements in wellbeing, and improvements in academic endeavour. CONCLUSIONS: this evaluation found significant improvements in the ability to cope with stress and increased attention and resilience in all students. Although results are not generalisable in this small evaluation, students reported increased concentration levels and improved focus, both of which are likely to impact positively on any psychological symptoms, particularly those related to workload pressures.