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USEFUL READING
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Reveal the real work
Article by Peter Hunter Johnston, Chair of the ISMPP European Committee and European Director of Skila, PMLIve.com, 26 March 2008 - [Read full article]
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 in this article. Read on to find out more...
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Mandatory disclosure of trial results for drugs and devices
Editorial by Dr Trish Groves, BMJ, 26 January 2008 - [Read full article]
The FDA Amendments Act, passed quietly last year, rules that any ongoing clinical trial involving a drug, biological product, or device regulated by the US Food and Drug Administration (FDA) must be registered at clinicaltrials.gov and that, from 27 September 2008, triallists must start to post in that same registry the results of those trials.3 This applies to all clinical trials of drugs and devices except phase I drug trials (preliminary safety studies for new products) and small feasibility studies of a device. Furthermore, it covers all trials - whether or not they are conducted and sponsored by industry and wherever they are conducted - if the products concerned need approval by the FDA.
So will a journal still want to publish a paper if its results have been posted on clinicaltrials.gov; if they have been debated widely in the mass media along with quotes from respected clinical experts, and - as is often the case - if they have led to a widely publicised rise or fall in the share price of the company that sponsored the trial? And, in the long run, will the role of peer reviewers and medical journals as the gatekeepers of new medical evidence become redundant? Read on to find out more about the BMJ's own position...
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Highlights from the Third Annual Meeting of the International Society for Medical Publication Professionals
Published by ISMPP, August 2007 - [Read full article]
The third annual meeting of the International Society for Medical Publication Professionals (ISMPP) was held in Philadelphia, PA, from April 23rd to 25th and was attended by approximately 400 publication professionals from the United States and Europe. The number of meeting participants grew by more than 40% over last year’s meeting! There were 29 sponsors and exhibitors; this too was a significant increase over 2006.
This year’s program, Ensuring Integrity in Medical Publications: Conflicts, Credibility, & Collaboration, focused on issues surrounding the management of conflict of interest (COI), the promotion of successful collaboration among all medical publication stakeholders, the need for increased transparency, and increased requirements for adherence to legal and regulatory guidelines and best practices. The 3-day meeting was comprised of 4 full-day workshops followed by 2 days of plenary presentations and discussions, a breakfast roundtable on the draft Ethics Statement of ISMPP, and 14 poster presentations on medical publication-related research and related topics. A new feature added to the 2007 meeting was podium presentations by a select group of ISMPP members, who were chosen based on the submission of abstracts on key topics of interest to the membership. The abstracts were selected by an independent abstract
review committee. In total, there were 8 such oral presentations, presented in parallel tracks on the second day of the meeting. Read on to find out more...
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Do Medical Journals Provide Clear and Consistent Guidelines on Authorship?
Published by Medscape, July 2007 - [Read full article]
Determining the authorship of scientific papers can be difficult and authorship disputes are common. Less experienced authors may benefit from clear advice about authorship from journals while both authors and readers would benefit from consistent policies between journals. However, previous surveys of authors have suggested that there are no universally known or accepted criteria for determining authorship. Liz Wager examined the instructions to contributors from 234 biomedical journals (randomly selected from the membership list of the World Association of Medical Editors and from Medline). Of the 234 instructions examined, 100 (41%) gave no guidance about authorship, 68 (29%) were based on the International Committee of Medical Journal Editors' (ICMJE) criteria, 33 (14%) proposed other criteria, and 33 (14%) said nothing except that all authors should have approved the manuscript. Of those instructions that were based on the ICMJE criteria, 18/51 (35%) cited an outdated version. Only 21 of the journals (9%) required individuals' contributions to be described. Liz conlcuded that journals do not provide consistent guidance about authorship and many editors are therefore missing an important opportunity to educate potential contributors and to improve the accuracy, fairness, and transparency of author listing. Read on to find out more... (registration required).
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Remote Control
Published by Pharmafocus, July 2007 - [Read full article]
Managers have to establish firm rules if remote working and 'virtual teams' are not to fall foul if communication breakdown
Vorsprung durch technik? Technological advances have allowed employees to spend increasing amounts of time working remotely away from the office. This change has been critical for advancement in the healthcare sector, which now demands a truly global workforce with employees spending an increasingly shorter time in one single office.
Research and experience from occupational psychologists Pearn Kandola warn that technological advances alone do not spell progress. As the tale of the sorcerer's apprentice suggests, new technology needs to be fully understood, if it is to provide benefit. Read on to find out more...
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International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer
Published by Current Medical Research and Opinion, June 2007 - [Read full article]
The International Society for Medical Publication Professionals (ISMPP) is an independent, nonprofit professional association with members from the pharmaceutical, medical device, and biotechnology industries; publication planning and medical communications companies; academia; and medical journal staffs, including editors and publishers. ISMPP’s mission is to support the educational needs of medical publication professionals by providing a forum to facilitate awareness and development of best practices in publication planning and implementation, and fostering consensus policies related to medical publishing. This position statement reflects our concern about the current climate of mistrust regarding the use of professional medical writers in the preparation of manuscripts. We acknowledge the skills and training of medical writing professionals and support their role in working with research teams to develop clear and concise manuscripts in a timely fashion. Further, we support complete and transparent disclosure of the role of the medical writer and the source of funding for the writing initiative in order to build awareness of, and trust in, the appropriate use of medical writing professionals. ISMPP endorses use of the contributorship model, which offers detailed information on the roles of all who participated in planning, conducting, developing, and publishing medical research. Further, we propose that this model be integrated into the standard operating procedures of the diverse organizations that comprise our membership because the responsibility for authorship disclosure is shared by sponsors, authors, study investigators, and medical writers. Finally, we commend the many organizations that have worked to increase recognition and understanding of the legitimate role of the medical writer, and are eager to work in concert with them to ensure the rigorous maintenance of all ethical standards for reporting the results of medical research. Read on to find out more...
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Dispelling the silo myth
Published by Pharmaceutical Marketing, June 2007 - [Read full article]
Martin Ellis of the Medicom Group of companies writes that the future for medical education in the UK looks bright, as NHS reforms and the consequent evolution in pharma’s thinking serve to drive it to the fore in pharmaceutical marketing.
Martin says, and I quote "PR and medical education should not be seen as cousins thrice removed, but as one and the same operators in a cohesive marketing services offering."
What do you think?
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The Changing Face of Medical Education
Published by Pharmafocus, June 2007 - [Read full article]
The editorial team at Pharmafocus asked some of the leading players in medical education about its role in pharma today.
They included questions like: "Is Medical Education the new PR?" "What are the Biggest Challenges in Med Ed?" and "How has the new Code changed Med Ed?".
And includes comment from the likes of Phil Sheldon (Resolute Communications), Dan Donovan (Envision Pharma), Carlyle Ware (Complete Medical Group), Marian East (MedSense), Joanne Taylor (Solaris Health) and Gail Flockhart (Caudex Medical).
Do you agree with their comments? I am sure Pharmafocus would love to hear from you.
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Med Ed comes of age
Published by Pharmafocus, May 2007 - [Read full article]
The growing influence of med ed means doctors, patients and pharma are now communicating on the same wavelength as never before. Gavin Atken looks at these rapidly evolving relationships.
He introduces his article by saying that "Even a casual observer will have noticed the large contribution pharma makes to postgraduate medical education, both in the UK and internationally. It's often said that industry funding accounts for about half of all the CME that takes place in the UK.
But however much it is valued, industry-sponsored medical education has come under increasing criticism, scrutiny and even regulation, and many now look to the US approach in which med ed is provided by specialist organisations operating in a tight regulatory framework as the way forward." Read on to find out more...
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Is your copy search engine friendly?
Published by PMLive, March 2007 - [Read full article]
Sarah Pooley of MSO.net gives advice about writing search engine friendly medical content and stresses the pivotal role search engine optimisation (SEO) has to play in the way a medical education website is constructed. Read on to find out more...
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What is medical education?
Published by PMLive, January 2007 - [Read full article]
Medical education is continually and rapidly changing and its distinction can sometimes become blurred. But what is it and how can it be used effectively? Read on to find out more...
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Organising effective meetings
Published by PMLive, January 2007 - [Read full article]
Meetings are very important for your company, but presenting an effective and successful one can become a small challenge. Read on to find out more...
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Effective Medical Education
Published by PMLive, January 2007 - [Read full article]
How can you make medical education successful and what are the many benefits? Read on to find out more...
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WHAT ELSE?
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FREE REPORTS
The following KeywordPharma reports are all highly relevant to medical communications and are freely available to download thanks to support from sponsors
Increasing Transparency in Pharmaceutical Marketing Communications: the new code from the European Federation of Pharmaceutical Industries and Associations (EFPIA) - written by Joan Barnard, Rene Lai and Andrew Robson, published February 2008
The Changing Face of CME in Europe: Where Are We Now? - written by Eugene Pozniak, published November 2007
Strategies and Solutions for Publication Planning and Execution Excellence - written by Liz Wager, published September 2007
Medical Writers and Peer-Reviewed Journals: Understanding the Rules and Responsibilities - written by Liz Wager, published June 2007
Download these KeywordPharma reports here
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