Promoting public access to clinical trial protocols: challenges and recommendations

Promoting public access to clinical trial protocols: challenges and recommendations

BACKGROUND Recognizing the value of promoting public access to clinical trial protocols, Trials pioneered the way for their publication over a decade ago. However, despite major advances in the public accessibility of information about trial methods and results, protocol sharing remains relatively rare. MAIN BODY Protocol sharing facilitates the critical appraisal of clinical trials and helps...

VigiAccess: Promoting public access to VigiBase

Sir, Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. The thalidomide tragedy in the late 1950s and early 1960s provided a strong impetus to initiating an international system of pharmacovigilance. The international drug monitoring system officially started in 1968 with ten countries pooling ADR data from their respective national systems.[1] As of March 2007, th...

Challenges and Barriers to Pregnant Women\'s Nutrition: Policy Recommendations

Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews

BACKGROUND Complete and transparent reporting of clinical trial protocols and reports ensures that these documents are useful to all stakeholders, that bias is minimized, and that the research is not wasted. However, current studies repeatedly conclude that pediatric trial protocols and reports are not appropriately reported. Guidelines like SPIRIT (Standard Protocol Items: Recommendations for ...

A review of promoting access to medicines in China - problems and recommendations

BACKGROUND Despite recent reforms, distorting funding mechanisms and over-prescribing still maintain severe financial barriers to medicines access in China. Complicated and interrelated problems in the pharmaceutical sector require a common framework to be resolved as fragmented solutions do not work. We present a preliminary assessment of the impact of the national healthcare reforms on access...