On January 20, members of the International Committee of Medical Journal Editors (ICMJE) announced a proposal that would require the authors of clinical trial publications to share the deidentified individual patient data that support their published results within 6 months of publication. Announced in an editorial published simultaneously in multiple medical journals, this proposal is…
When President Obama’s White House Task Force meets for the first time this week, it faces a lofty charge: “Let’s make America the country that cures cancer once and for all.” His proposed Cancer Moonshot 2020 initiative will provide much needed funding for research, will encourage collaboration between industry and academia, and will undoubtedly lead…
The US Food and Drug Administration (FDA) review of drugs, although guided by broad standards, remains individualized. Each drug or drug class faces unique challenges during the FDA review phase – thus no two reviews are exactly the same. Each review division within the FDA has its own approach, and evaluations often differ among the…
The International Society for Medical Publication Professionals (ISMPP) recently released its latest guidance—GPP3, or Good Publication Practice 3. This is the first update of the ISMPP guidance since GPP2 was released in 2009. A steering committee first met to draft the guidance, and then ProEd colleagues, Laura McCormick, PhD; Heather Hlousek, and Jim Cozzarin, ELS,…
