Precompetitive consensus building to facilitate the use of digital health technologies to support Parkinson Disease drug development through regulatory science

Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson’s Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies

Vigor de sementes e competição intra-específica em soja Seeds vigor and intra-specific compettion in soybean

O experimento teve como objetivo avaliar o efeito de combinações da distribuição das sementes de soja de alto e baixo vigor ao longo da linha de semeadura, sobre o comportamento individual das plantas resultantes e o desempenho geral das comunidades. Utilizou-se o cultivar de soja BRS 154. Foram avaliadas seis combinações de vigor das sementes na linha de semeadura. As plantas provenientes das sementes de alto vigor apresentaram maior índice de área foliar, produção de matéria seca e rendimento de sementes, em relação às plantas provenientes das sementes de baixo vigor. As plantas originadas das sementes de alto vigor não exerceram efeito de dominância sobre as plantas provenientes das sementes de baixo vigor, adjacentes na linha de semeadura. O aumento na proporção das sementes de alto vigor no estabelecimento das comunidades de plantas, proporcionou acréscimos lineares no índice de área foliar, na produção de matéria seca e no rendimento de sementes. A população formada somente por plantas oriundas das sementes de alto vigor, apresentou rendimento 30% superior à população constituída somente por plantas originadas das sementes de baixo vigor.<br>The objective of this research was to evaluate the effect of high and low vigor soybean seeds combinations distribution in the planting row on individual plants and different communities performance. The cultivar BRS 154 was used. Six seed vigor combinations were used. Plants from high vigor seeds had higher leaf area, dry matter accumulation and seed yield than plants from low vigor seeds. Plants from high vigor seeds do not have dominance effect on plants from low vigor adjacent in the row. The increases in proportion of high vigor seeds in the establishment of the plants communities provided linears increments in leaf area index, dry matter production and seeds yield. The population established with all plants from of high vigor seeds out yield in more than 30% the population established only with plants from low vigor seeds