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

Variações espaço-temporais no estoque de sementes do solo na floresta amazônica

A dispersão eficiente, a longevidade e a capacidade das sementes de permanecer em estado latente a espera de condições adequadas de germinação no banco de sementes do solo da floresta garantem a presença de espécies arbóreas pioneiras nas áreas perturbadas. As variações estacionais e espaciais na densidade e na composição florística do banco de sementes em Florestas Tropicais Úmidas são assuntos ainda pouco compreendidos. Este trabalho verificou a existência de modificações espaço-temporais do banco de sementes presente em áreas de Floresta Tropical úmida localizadas próximas a Manaus, AM. Em cada uma das seis áreas estudadas, foram coletadas 40 amostras circulares de solo superficial (10 cm de diâmetro e 2 cm de profundidade) ao acaso. Essas amostras foram coletadas a cada dois meses, entre agosto/2004 e junho/2005,. As amostras de solo foram distribuídas em bandejas em casa de vegetação e a emergência das sementes presentes no solo foi acompanhada por 4 meses. Houve uma redução significativa (H: 14,09, p < 0,05) na densidade média de sementes no solo em junho (início da estação seca) em relação a fevereiro (meio da estação chuvosa). Houve também diferença significativa (H: 188,72, p < 0,05) na densidade média de sementes do solo presente nas diferentes áreas amostradas. Assim como para outras áreas de florestas tropicais, o banco de sementes permanente da floresta foi dominado por espécies pioneiras, principalmente da família Melastomataceae, enquanto as espécies típicas da Floresta Tropical madura foram raras no solo florestal

Exploration of whether socioeconomic factors affect the results of priority setting partnerships: updating the top 10 research priorities for the management of Parkinson's in an international setting

Objectives Explore whether socioeconomic differences of patients affect the prioritisation of pre-existing research questions and explore the agreement between healthcare professionals (HCP) and patients in priority setting partnerships (PSPs). Design and setting Prospective, three centre survey across UK (400 participants), Tuebingen (176 participants) and Luxembourg (303 participants). People with Parkinson's (PwP), research participants, relatives and HCP associated with three Parkinson's cohort studies were invited to participate, along with linked centres (clinical care settings, research groups, charities). Responders were encouraged to pass on the survey to friends/families/carers. Methods The survey involved rating the importance of research questions on a Likert scale, allowing for the generation of one new question participants felt was particularly important. Collection of demographic information allowed for comparisons of priorities across a range of socioeconomic variables; the top 10 research priorities for each group were then compared. Questions added by participants were subject to a thematic analysis. Results 879 participants completed the survey (58% PwP, 22% family/friends, 13% HCP, 4% carers). Finding the best form of physiotherapy for PwP was the number one priority across the majority of analyses. HCP were the only subgroup not to place physiotherapy in the top 10. Factors most likely to affect prioritisation in PwP included educational level, presence of carer support and disease duration. There was little difference between other socioeconomic categories. Conclusions Socioeconomic factors modestly influenced some research priority ratings but did not significantly affect the top priority in most comparisons. Future studies must ensure patients from a range of socioeconomic backgrounds are recruited, ensuring results generalisable to the public while also identifying any key disparities in prioritisation. PSP should also take care that HCP do not skew results during prioritisation of questions, as in this study the most important priority to patients was not identified by professionals