One sign that publication planning has been recognised as a core discipline in the pharmaceutical and biotech industries is the establishment of the International Society for Medical Publishing Professionals (ISMPP).
Founded three years ago the society now has more than 600 members and attracted nearly 400 delegates to the annual meeting in 2007. Membership is drawn from bio-pharma and medical device companies, from communication agencies and many publishing companies, as well as freelance writers, editors, and academics. Its aim is to serve the educational needs of those involved in publication planning and related activities in the pharmaceutical and biotech industries. Some of the topics that the society is currently exploring are outlined below.
NEW US LEGISLATION
On September 27 2007, President Bush signed into US law the Food and Drug Administration Amendments Act (FDAAA). The bill includes the fourth renewal of the Prescription Drug User Fee Act (PDUFA) and renewal of Medical Device User Fee Act (MDUFA). There is also a new section in the bill that covers clinical trial databases and includes regulations that mandate the registration of most trials and the public disclosure of results, generally within 12 months of Last Patient Last Visit (LPLV).
If a study involves any US centres or patients then you need to follow the new legislation. If this is not the case but the product is going to be marketed in the US it is debatable whether or not the Bill applies. Many companies seem to be playing it safe and registering/disclosing these studies. For an authoritative answer consult the regulatory or compliance section in your company.
We await a formal ruling from the International Committee of Medical Journal Editors (ICMJE) on whether disclosure will be viewed as prior publication by journal editors. Comments from editors of various major journals at recent conferences indicate that ICMJE will recognise that sponsors and investigators now have a legal requirement to post their results online and will not view these postings as prior publication. Although an editorial in the January 25 issue of BMJ addresses a number of questions regarding FDAAA, many remain.
During the past couple of years we have all got used to the need to register a study before First Patient First Visit if we want the eventual results published in an ICMJE journal. We are also familiar with the old requirement that results of a study must be disclosed 12-24 months after LPLV. This new legislation, however, must be the final nail in the coffin for the practice of holding back all data until the last moment and publishing it in the last few months building up to launch. Whether this was ever a good strategy is now a moot point as results are going to have to be disclosed in a more timely and predictable way.
Probably the greatest impact of the US Bill on publication professionals is the requirement for speed. You are not obliged to have your data published in a peer-reviewed journal within the 12 months after LPLV, but you are required to post the key results. It is preferable to back these data with references in a respected journal rather than resorting to 'data on file' or 'www.clinicaltrials.gov'.
AUTHORSHIP AND GHOSTWRITING
The issues of unearned, or 'guest', authorship and ghost-writing are also prompting debate. There has been much criticism, some of it justified, of the publishing process and pharma's role in the development of publications. These two problematic areas are opposite sides of the same coin; people are named as authors who should not be and there are people who should be named (as authors or contributors) who are not. The ICMJE authorship requirements are clear and seem to be being followed - to be named as author there are three criteria that have to be met. The individual must:
1. Make substantial contributions to the conception and design,
or acquisition of data, or analysis and interpretation of data
2. Draft or revise the article critically for important intellectual content
3. Approve the final version for publication.
The ICMJE also advises that named authors should be able to defend the manuscript's content, at least in part, against question or criticism. So if the head of the department makes a few suggestions about a trial's design but has not read through the final manuscript or made comments and has had no further input, then they should not be a named author.
The ICMJE guidelines go on to say that, all those who qualify [for authorship] should be listed. So if an industry employee has a major role in protocol design and conduct of the trial, or carried out the bulk of the data analysis, revised the manuscript and approved the final draft, then they should be listed as an author. In the past there has been a tendency for industry personnel to be left off the authorship list because the naming of these scientists has resulted in negative reviews or reactions. Hopefully this will change in this era of increasing transparency.
The situation with respect to ghostwriting is equally straightforward; it is not permitted. Any confusion surrounding this is more likely to be about the terminology. Writing support that is acknowledged is perfectly acceptable - professional writers will not normally satisfy authorship criteria but should be acknowledged as contributors, a role that ICMJE recognises in its guidelines. It is unacknowledged writing support that is classed as ghostwriting and is not acceptable. The ISMPP makes this clear and has recently published a position paper on the topic and also included it in its code of ethics.
Medical writers and publication professionals have a vital role to play in preventing inappropriate or unethical practices, to ensure that the highest standards are maintained, and confidence and credibility in the publication of industry-sponsored clinical research is restored. If asked to include or exclude an author in a manner that conflicts with ICMJE guidelines, you should decline. If you, a colleague, or a group of colleagues, played a substantial role in the development of a manuscript, that contribution should be acknowledged, so cite the ICMJE and ISMPP guidelines and insist upon acknowledgement of contribution.
Experienced publication professionals will usually agree that the single biggest cause of delay in generating publications is the internal review and approval process. Typically your agency or medical writer will deliver their first draft manuscript inside the allotted time and off it will go for review - and this is when the trouble starts. There is no easy answer but here are a few tips gained from experience:
1. Use a publication policy
If your company does not have a policy make sure they write one quickly. So many of the problems you may encounter, such as how and when to involve your authors, should be dealt with and sorted out in this policy. This makes life much easier later on in the process.
2. Involve the authors
Engaging fully with the authors right from the start is crucial Address any 'tricky' issues early and discuss timelines, review processes and journal selection.
3. Agree workflows
For each of the key manuscript types agree exactly how these will be prepared and reviewed. Do it logically, step by step and include agreed timelines. Keep them realistic - neither too long nor too short.
4. Make good use of outlines
Start with a good outline of the paper, get agreement on it from all authors before writing the full article.
5. Forward planning
If you know when key data will be available, plan a publication team meeting in advance to discuss the results and the paper. Gather references for the discussion; plan how you might deal with different results outcomes. Use of a 'shell' manuscript, where certain sections such as 'methods' are written before the final data is available, sounds like a good option, but may not always work out as effectively as you may have hoped.
6. Streamline internal review
Endless internal reviews will delay your projects. Reach agreement on who really has to see which drafts at each stage and separate 'required' reviewers from 'optional' reviewers. Keep the number of required reviewers to a minimum. Try getting one person to tidy up all first drafts so that they are at a high standard before sending them out for wider review. Consider using review meetings rather than endless rounds of electronic document review. Distinguish 'discretionary' reviewers' comments from those that are mandatory.
7. Try collaborative document review
One topic to be discussed at the ISMPP conference in April 2008 is collaborative document review technology. This allows reviewers to see what everyone else is saying without the delays associated with sequential reviewing.
The New England Journal of Medicine (NEJM) rejects 19 out of 20 manuscripts submitted. With this in mind, do not waste time submitting to the major journals unless the data really are stunning. Listen to your agency - they are better placed to be more objective - most authors agree that they would love to add a high profile citation to their bibliography. All too often a good manuscript will be sent to two or more major journals before finally being submitted to the one originally recommended. This may delay its appearance by more than a year.
Choosing the right journal to publish is a difficult decision. To ensure that manuscripts reach the correct target audience quickly there are more options to consider than the traditional subscription journal. In this article we are not going to cover the whole subject but instead highlight a couple of perspectives.
OPEN ACCESS VS SUBSCRIPTION
As in many other areas of our life, the internet is having a profound effect upon the publishing industry. For many of us the internet is synonymous with the concept of the free exchange of information. We only have to consider the wide variety of internet search tools used on a regular basis where, usually, we can access the information for free. This is not true in medical publishing, Medline is free but most medical journals only offer an abstract without charge. If you want full text, then you'll either have to subscribe to the journal or buy a download of the individual article. How often do we chase down an article up to the point where we have to pay and then stop?
For complex papers that are going to be of interest to a very specialised audience, publishing in one of the traditional subscription-only journals is appropriate because most of the target audience will be subscribers and your sales force can also be used to distribute reprints.
Some manuscripts have a wider appeal to a larger, more disparate and less specialised audience, who would not want to pay to subscribe or to download the article. These readers will not have access to subscription-only journals and, unless they are doing some serious research, they probably won't want to pay to download the article. We are, therefore, seeing an increasing trend for publication plans to include open access journals - as well as traditional subscription-only journals - to meet the needs of both types of readers. It is worth noting that PLoS Medicine has an Impact Factor of 13.75, not as good as the NEJM (51.296) but higher than that of the BMJ (9.245).
Think carefully about the type of person who may want to read your paper, consider if they will have full access to the specialist journals, and if not, consider using an open access journal.
ONLINE DATA SUPPLEMENTS
If you think about it, print is a fairly restrictive technology for sharing information when modern communication usually includes audio and video. Many journals now allow additional information to be added to the online version of the printed paper. If, in the course of the study, interesting video or audio material was collected then look for a journal that will allow this to be added to the online version.
THE CERTIFIED PUBLICATION PLANNER
ISMPP is seeking to expand its professional education offerings by developing an internationally recognised certification programme - the first of its kind for the medical publication industry.
This programme will set new standards for medical publication professionals and help towards ensuring the highest level of integrity in the publication of clinical trials results and other clinical information.
The development of this programme is underway and should be launched before the end of 2008. This will enable pharma companies to ensure quality and compliance in their publication planning by employing certified publication planners to work on their accounts.
Peter Hunter Johnston is Chair of the ISMPP European Committee and European Director of Skila. He may be contacted at PHunterJohnston@skila.com.
The following members of the ISMPP European Committee also contributed to sections of the manuscript:
Jane Nunn, Complete HealthVizion
Phil Garner, Informa Healthcare
Piers Allen, Informa Healthcare
Angela Cairns, KP360 Healthcare Communications Network