Implications of ICMJE’s Data Sharing Proposal

ProEd-ICMJE-Data-Sharing-Proposal-PostOn 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 based on the belief that authors have an “ethical obligation to responsibly share data generated by interventional clinical trials.” It also reflects the broader agenda of the ICMJE to foster greater transparency and reduce the potential for bias. This new requirement will likely go into effect in 2016 and will affect any clinical trial that enrolls patients beginning 1 year after ICMJE adopts the requirement.

This proposal makes a lot of sense in the interest of transparency, but what does it mean for clinical investigators involved in research and the companies that sponsor that research? To quote the ICMJE authors, “enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used.” Continue reading

President Obama’s Cancer Moonshot 2020 Initiative: How Big Is the Challenge?

Apollo rocket blasting offWhen 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 to important advances in our understanding of cancer and how to treat it.

Although this initiative is noble and well intentioned, calling for a “cure for cancer” oversimplifies the challenge and is based on an outdated understanding of the disease.

The public needs to understand that cancer is not one disease; it’s hundreds of different diseases, and it’s more complex than anyone imagined back in 1971 when President Nixon first declared war on cancer. Those involved in cancer research know that conquering cancer, in all its varied forms, is truly a global endeavor that will require a sustained commitment for decades to come. While a challenge to be the “country that cures cancer” stirs our patriotic spirit and conviction that American biomedical know-how can render cancer irrelevant in our lifetime, the reality is that meaningful progress will require international collaboration.

Are we, as a nation, prepared to take on that challenge and lead such a charge? The President has taken the first step, appointing Vice President Joe Biden to lead the White House Task Force. But now the difficult work begins. Can we balance competing priorities and sustain both our political will and financial commitment for the many years that such an effort will undoubtedly take? Continue reading

Can You Predict Whether You Will Face an FDA Advisory Committee?

blog header linkedin - Prediction Ad Com v5 resizeThe 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 centers. To help understand the review process, the team at ProEd Regulatory sought to learn from the past to inform our future. We reviewed applications submitted to the Center for Drug Evaluation and Research (CDER) data over the last 70 years to see what patterns might emerge. Although the largest proportion of products (drugs and biologics) fails between discovery and Phase 3, an evaluation of applications submitted to the FDA over the last 70 years shows that the vast majority of products that reach the submission stage are ultimately approved (Figure 1).1
predict_fig_1It wasn’t until the Kefauver-Harris Drug Amendments of 1962 that the FDA required sponsors to demonstrate both efficacy and safety of their drugs prior to market access. In the wake of this significant legislation’s impact on drug development, we still see a consistent flow of approved applications and a corresponding subset of new molecular entities (NMEs) (Figure 2).1

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GPP3: Is It a Better Guidance?

blog header linkedin - GPP3 v3 FINAL WP

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, had the privilege, with 91 reviewers (from agencies and sponsors), to provide critical feedback before the new guidance was published in Annals of Internal Medicine.1

So, what are the important changes from GPP2? In addition to being more user-friendly than its predecessor—with an overall simplification of language and format, a new Guiding Principles section, and quick reference tables that address guidance on authorship criteria and common authorship issues—GPP3 also reflects some important updates and new elements1:

  • Updated International Committee of Medical Journal Editors (ICMJE) 2013 authorship criteria
  • Common issues regarding authorship
  • Improved clarity on author payment and reimbursement
  • Additional clarity on what constitutes ghost or guest authorship
  • Expanded information on the role and benefit of professional medical writers
  • Guidance for appropriate data sharing

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