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New time constraints imposed by the FDAAA limit the strategic options available to publications professionals

An image of a stopwatchSince the US Food and Drug Administration (FDA) Amendment Act (FDAAA) was signed into law in September 2007, the publications landscape has changed dramatically. The impact on publications and communications teams within the industry has been significant, with one of the major changes being how and when clinical trial data are disseminated. Specifically, the options for disseminating these data have been restricted.

The act mandates that clinical trials are registered prior to trial commencement and that the results are posted along with adverse event data. Publication of the trial results is required 12 months after last patient last visit (LPLV).

The 'hold and fire' strategy — whereby phase III data and all sub-group analyses are published simultaneously to support launch — is now a thing of the past.

Once a trial is registered and recruitment complete, it is possible for physicians, patients, investors, media and competitors to estimate the date of trial completion. This also means, therefore, that they can predict when new product data will be published, which removes a lot of the strategic component involved in publications planning. Since the timing of data communication is now essentially fixed, patient recruitment becomes the variable parameter and the milestone upon which strategic communication plans can be built.

Assuming first–time acceptance at a target journal, it is possible for a writing group or committee of external authors working together with a pharma sponsor and a medical communications agency to develop a manuscript, submit it to a journal, make amendments based on comments received during peer review, re-submit and publish within the required 12-month time frame. However, authors frequently aim for high-impact journals to secure recognition for their contribution to medical research. Prior to FDAAA this was a feasible strategy because, following rejection by a high-impact journal, the manuscript could be repeatedly re-submitted to any number of journals with a lower impact factor, until such time as it was accepted. Since the time from submission to publication can sometimes take up to a year, the first–choice, target journal now needs to be more realistic to ensure first–time acceptance and publication within the required 12–month time frame.

The rise of open access
Previously, leading medical experts and authors had resisted publishing clinical research in open–access journals. This slow adoption by academia is due to natural conservatism, the academic credit given to where people publish, impact factors and the profitability of scientific publishing. However, the new time constraints on a sponsor to make trial results available now make open access publishing a more practical choice.

The reality is that submission to high-impact journals — such as the New England Journal of Medicine, the Journal of the American Medical Association, the British Medical Journal, the Lancet, the Journal of Clinical Oncology, Circulation and so on — is potentially a high-risk strategy because, if the paper is rejected, there may not be enough time to re-submit to an alternative journal. If the article is indeed rejected, fast publication in an open access journal is a likely option. It's win or bust.

The popularity of open access is growing. For example, the Directory of Open Access Journals, which increases the visibility and ease of use of more than 5,000 open access scientific and scholarly journals, was the winner of the Scholarly Publishing and Academic Resources Coalition (SPARC) Award 2009.

Peer review
Not only has the pharmaceutical and publishing industry been heavily scrutinised, but more recently the media spotlight has also fallen on the peer–review process. The peer–review system has been criticised for the anonymity of reviewers and for being too slow and time consuming, subject to reviewer bias and ineffective at detecting fraud.

Richard Smith, former editor of the British Medical Journal, who has written extensively about peer review, said: "There's lots of evidence of the downside of peer review, and very limited evidence of the upside."

Once again open access publication offers a solution. The open access journal Frontiers provides rapid and fair peer review, which enables the entire academic community, as well as the general public, to comment on an article as part of post–publication review. Other examples are DocGuide, an iPhone application that allows doctors to make post–publication comments on medical and scientific articles, and the American Journal of Medicine blog, which allows any reader, not just doctors, to make a comment on selected published articles. Is this where publications meet social media? Public commentary on company clinical trial results databases cannot be too far away.

While open access and post-publication review go some way to combatting issues in the publishing industry, controversy and misunderstandings surrounding the contribution of professional medical writers (ghostwriters) remain. Articles such as 'How ghostwriting threatens the credibility of medical knowledge and medical journals' (published by Haematologica) question, not only the credibility and reputation of stakeholders involved in the publishing industry, but also the integrity of academic medicine itself.

US Senator Charles Grassley's report on ghostwriting in medical literature reviews interactions between the pharmaceutical industry, academic physicians and scientists (I hope he wrote it himself). The report cites an article from PLoS Medicine which suggests the use of a mandatory checklist to help editors detect ghostwriting and help authors avoid ghostwriters. One of the checklist questions would ask if the source of funding for a medical writer's services is identified in the acknowledgments.

For further insight, the Medical Publishing Insights and Practices (MPIP) initiative has recently developed the Authors' Submission Toolkit: A practical guide to getting your research published. The toolkit goes some way to help fill an unmet educational need between author practices and editor expectations.

Yet despite these efforts to increase transparency, some leading academic institutions in the US have banned authors from writing research articles in partnership with commercial organisations if full disclosures are not made.

Good publication practice
Publication professionals in the pharmaceutical industry work to guidelines, regulations and policies when implementing good publication practice (GPP). A publication policy based on International Committee of Medical Journal Editors (ICMJE), GPP1 and GPP2 guides will cover publication bias (suppression of negative findings), redundant publication, relations between investigators and trial sponsors, the role of ghostwriters, data access, publication steering groups, publication agreements, disclosures, payment to authors and the definition of the role of publication professionals and publication planning.

Education about what these guidelines mean in practice to the wider group of stakeholders involved in publications is fundamental to successful adoption. The process and rationale for author selection should be documented, along with the functions involved. Engaging authors who have appropriate and documented expertise and who bring a clinical perspective is important. A formalised publication or authorship agreement between sponsor and author should state that sponsors provide authors with copies of their publication policy and that authors are entitled to full access to data, with the freedom to publish results.

Other recommendations for publication agreements covered in GPP 2 include: authorship criteria; disclosure of funding, support and conflicts of interests; author requirement to write publication in agreed time frames; agreement about intellectual property rights; avoiding premature or duplicate publications; a process to resolve disagreements during review, and the sponsor's right to review and comment.

Ensuring authors know what is expected of them and what they are entitled to through formalised authorship agreements is increasing. Adherence to GPP is not a legal requirement, however lawyers are examining how companies select clinical investigators and authors; specifically, they are interested in any documented evidence of marketing involvement in publication planning and author selection.


Physician/pharma/publisher/agency cycle

Publishing cycle

Many organisations provide education and support for publication professionals, medical communication agencies and publishers, among them the International Society of Medical Publication Professionals (ISMPP), The International Publication Planning Association (TIPPA), ICMJE and the Committee of Publication Ethics (COPE), as shown in the diagram. The diagram also shows, however, the shortage of bodies that provide support to authors.

This point is pertinent one as incomplete disclosures by authors and researchers are increasing and this is sometimes due to a misunderstanding of journal requirements about reporting financial conflicts of interest. Journals like JAMA have even started to name and shame authors who are getting it wrong.

Industry can help authors by supporting non-product related valued education about publishing research, which will be increasingly helpful as the requirements are set to become even more complex. This move would go some way to helping physicians keep abreast of the changes and would uphold the reputation of the pharma industry itself, as well as that of the publishing industry.

A new uniform disclosure form was recently introduced and adopted by all ICMJE-member journals. Authors are required to complete a single disclosure that they submit to each journal, which simplifies the process of disclosure of competing interests and reduces the potential for authors' misunderstanding.

This point is not just relevant for journals: disclosure requirements for investigators within academia are also set to change. Under new proposed rules from the US National Institutes of Health (NIH), researchers will have to disclose funding of $5,000 or more from companies, or any other industry, which will then be posted on a public website. The NIH database will precede the Physician Payments Sunshine Act database that will be introduced in 2013.

Both the NIH database and Physician Payments Sunshine Act database will disclose all payments to physicians in public. While authors do not receive remuneration for writing publications, these databases will serve as compliance tools for author disclosures of financial conflicts of interests to journals during the submission process.

As well as pharma disclosing any payments to physicians, the FDA is also now asking healthcare professionals about any questionable promotion of medicines as part of the 'Bad Ad Program'. Launched in May, the scheme encourages physicians to report any activities and messages in print or in person that they consider to be false or misleading. This physician/pharma/FDA triangle (in which each party is responsible to the other two) is part of healthcare reform and is a platform for patient protection.

Another area to consider is prior publication. Results posted in the clinical trial registries are not currently considered prior publication, but as more results databases emerge and their role evolves to include more detailed descriptions of trial results beyond those included in, ICMJE may need to amend its recommendations. This would have an enormous impact on the way companies communicate their clinical trial data.

Other potential changes in future may include: disclosure of the peer reviewer; disclosure of their comments and their conflicts of interests; disclosure of payments to medical communication agencies; identification of the principal investigator and disclosure planning. These areas should be monitored closely as the publications planning landscape continues to evolve.

The Author
Clare Nolan
is co-founder and director at Recognition Academy

To comment on this article, email

16th September 2010


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