Developing Global Norms for Sharing Data and Results during Public Health Emergencies

Abstract

Vasee Moorthy and colleagues describe the outcomes of a recent, WHO-led meeting on sharing research data and results during public health emergencies.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…U tom je smislu IOM objavio posebne smjernice za razmjenu podataka u kliničkim ispitivanjima 20 . SZO je prvo predstavio izjavu o javnoj objavi rezultata klinič-kih ispitivanja, a zatim poticala razmjenu podatkovnih nizova iz istraživanja kad god je to primjereno [21][22][23] . SZO je Nakon toga SZO je razvio globalna pravila za razmjenu podatka i rezultata tijekom izvanrednih javnozdravstvenih stanja, koja su osobito usredotočena na kliničke, epidemiološke i genske osobine novih zaraznih bolesti te na eksperimentalne lijekove i cjepiva.…”

“…SZO je Nakon toga SZO je razvio globalna pravila za razmjenu podatka i rezultata tijekom izvanrednih javnozdravstvenih stanja, koja su osobito usredotočena na kliničke, epidemiološke i genske osobine novih zaraznih bolesti te na eksperimentalne lijekove i cjepiva. U izvanrednim se situacijama podatci moraju razmjenjivati brzo, prije no što su te informacije formalno objavljene 23 .…”

Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…(20) The WHO initially presented a statement on public disclosure of clinical trial results and, subsequently, encouraged sharing of research datasets whenever appropriate. (21)(22)(23) More recently, the WHO developed global norms for sharing data and results during public health emergencies, with special focus on clinical, epidemiologic and genetic features of new infectious diseases and experimental therapeutics and vaccines. In emergency situations, data needs to be shared quickly before the information is formally published.…”

“…In emergency situations, data needs to be shared quickly before the information is formally published. (23) Finally, the National Health, Lung and Blood Institute (NHLBI) presented detailed data-sharing practices allowing public access to trial raw data and developed a data repository currently including over half a million patients from over 100 trials and observational studies. (24) In 2015 the NHLBI discussed its intent to make public the digital data from its funded trials.…”

Lessons learned from Ebola Vaccine R&D during a public health emergency

“…Finally, the third approach supports the development of new norms and standards adapted to the epidemic context, as a way to overcoming the scientific and coordination barriers faced by R&D during epidemics. Specific activities include the following: – Supporting expansion of local capacity to implement adequate clinical trial study designs; – Developing guidance and tools to frame collaborations 11 and exchanges, and; – Anticipating evidence needs to inform regulatory review and policy development.…”