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Transcript:
Date: 03/12/2010
Welcome to the PharmaVOICE Webcast Network.
In this episode, we covered the Medical Publishing Insights and Practices Initiative (MPIP) – a relatively new development co-sponsored by Amgen, AstraZeneca, GlaxoSmithKline, Pfizer, and the International Society for Medical Publication Professionals, otherwise knows as ISMPP.
Our thought leaders in this episode are Bernadette Mansi, Scientific Communications Strategic Head, Cardiovascular, Metabolism, and Ophthalmology at GlaxoSmithKline and Dr. Trish Groves, Deputy Editor of the British Medical Journal.
Ms. Mansi and Dr. Groves discuss what MPIP is, who’s behind the initiative, its goals and accomplishments, and how the pharmaceutical industry and journal editors and publishers are benefiting from collaboration on standards to elevate trust and transparency in publishing industry-sponsored studies.
The latest undertaking is the creation of an author submission toolkit, a practical guide to getting your research published being rolled out at the 6th annual meeting of ISMPP, April 19th-21st in Arlington, Virginia.
To learn more and register, visit www.ISMPP.org.
I’m Dan Limbach, your host and producer of the PharmaVOICE Webcast Network.
Dan: Bernadette and Trish, welcome to the podcast program.
Bernadette: Thank you, it’s great to be here.
Trish: Thanks very much for inviting us along.
Dan: We’re here to talk about MPIP today. Bernadette, why don’t you give us a brief overview on what the organization is all about.
Bernadette: Sure. MPIP stands for Medical Publishing Insights and Practices, which was founded in 2008 by members of the pharmaceutical industry and the International Society for Medical Publication Professionals with the goals of elevating trust, transparency, and integrity in publishing industry-sponsored studies.
Dan: Who’s involved with MPIP?
Bernadette: The organization is a collaboration sponsored by Amgen, AstraZeneca, GlaxoSmithKline, Pfizer, and ISMPP with specific goals – one of gaining a better understanding of the issues and challenges that journals face in publishing pharma-sponsored studies and then secondly, promoting collaboration to develop and implement some practical solutions to these challenges.
Dan: What are some of the accomplishments of MPIP in the 2+ years since it’s been founded?
Bernadette: As you know, any successful collaboration really is built on a foundation of insight and mutual understanding. So the first phase of the MPIP collaboration was focused on obtaining key insights from the journal editors and publishers on the issues and challenges that they perceive to be barriers in transparency and trust in publishing industry-sponsored research. So this was done through independent interviews and discussion forums with journal editors from US and Europe.
Some of the issues that surfaced centered around the need to ensure that all pharma studies, positive and negative, see the light of day in publication, the need to raise standards in manuscript preparation and submission, including increasing transparency in authorship and financial disclosure, which really is key, and the need to increase efficiency in the submission process to accommodate the increased manuscript volume.
Results of this research were presented at ISMPP at last year’s annual meeting and then in the second phase of the initiative, which is currently ongoing, the focus is on identifying and implementing solutions to the issues that were raised in phase 1.
So for example last year, MPIP hosted a roundtable where editors, publishers, and co-sponsors met to discuss opportunities to streamline the publication process, which was one of the areas of mutual interest and a manuscript on this discussion and the recommended solutions has been submitted for publication. And then in addition, we are currently finalizing an author submission toolkit to guide best practice in manuscript submission and development.
Dan: It sounds like you’ve been busy. What needs led you and the other co-sponsors to form MPIP?
Bernadette: Industry-sponsored clinical research, as you may be aware, has become more open and transparent in recent years. This is due to changes in policy regulations, technology, as well as a general trend toward increased information, access, and sharing. The goals of greater transparency and this expanded access to data are shared by both the journals and industry and new policies have been implemented on both sides to affect this change. However, these trends, in turn are driving a significant increase in the volume of manuscripts that are coming through the system and this poses challenges to both journals and industry.
For pharma, the major challenges are twofold – how to streamline the submission process to avoid placing a greater burden on authors and then finding suitable venues to publish this research, which is mostly derived from early phase trials that frequently have limited readership appeal. For the journals, it’s about finding a pool of reviewers to keep up with the increasing volume of manuscripts and streamlining the process to reduce some of the editorial resource demands.
We believe that we can succeed in this goal only if the journals and industry collaborate and until MPIP was created, there really wasn’t a suitable forum for journal-pharma engagement, and in only two years, we’ve already seen some of the benefits of this forum in fostering some mutual understanding and then collaboration towards solutions.
Dan: Bernadette, you briefly mentioned benefits. Can you expand a little bit more on what some of the benefits are?
Bernadette: Some of the benefits are really the opportunity to have an open dialogue with the journals and present the pharma point of view, but also to hear directly from them, what is important to them, what expectations do they have. We’re fostering mutual understanding and collaboration toward solutions.
Dan: Fantastic. Trish, from a journal’s perspective, what needs in the current medical publishing environment are MPIP helping to meet?
Trish: Well we hope that more industry-sponsored research will get out there. It will be peer reviews unpublished in the right places and that’s obviously good for the sponsors and the investigators, but it’s also really good for readers, clinicians, people doing systematic reviews, and those writing clinical practice guidelines and ultimately, we hope for patients because we want all relevant evidence to be available to people so that they can understand the work that’s been done and they can decide whether it’s any good or not. So that’s one really important thing that we hope this initiative will help.
We’ve talked a bit about the increasing workload for journals and the fact that it’s likely to increase even more as industry tries to get more early phase studies published. So that’s fine; it’s great to have more good work to publish, but then we hope that this initiative will help people choose the right journals and then open up the right kind of dialogue with editors so that the good work does, indeed, get published.
We also hope that this initiative will increase trust between industry investigators, authors, publication planners, and medical writers with journal editors and we hope that editors who were currently rather prejudice against industry studies will feel more comfortable about publishing industry-sponsored research because of this initiative.
Dan: Excellent. What makes journal editors so excited about supporting MPIP?
Trish: It’s important to say that so far, only a relatively small number of editors have taken part in the various phases of this initiative, but we do hope that other editors will come on board and find the outputs of the initiative useful and, particularly, the toolkit. As an editor myself representing the BMJ, I’m here because we want to be constructive and help improve industry practices when it comes to publication and increase transparency.
We also want to help improve communication and of course, we want to publish great work whether it comes from industry or academia and you could argue, of course, that publishers stand to make more money if they get more open access fees, for instance, from industry studies or, indeed, sell more reprints. You have to remember, there’s commercial interest on both sides of this.
Lastly, as an editor, it’s great to be able to open up the black box of what we do. So it’s useful to say, well, it’s worth trying writing to the editors before submission and saying here’s what I’ve got, do you think that your journal might be the right journal? Or saying, well actually, I’m not sure about this decision here to reject this work. Maybe we didn’t present it quite right. Could we appeal, could we have another go? And it’s good to open up that black box.
Dan: Absolutely. Now let’s talk about the author submission toolkit. Why is it being developed and how will the relevant stakeholders benefit?
Trish: We already have lots of guidance for authors on how to write manuscripts and there is guidance, for instance, the International Committee of Medical Journal Editors and although there are only 12 journals that actually form that committee, their guidance, their standard instructions are actually followed by more than 800 journals worldwide now and there are other bodies, such as the Council of Science Editors and the World Association of Medical Editors and many others, producing good guidance on how to write manuscripts.
Now more recently, there’s the Good Publication Practice guidance in it’s second version; so that’s GPP2, which is specifically focused on papers coming from industry.
We’ve got all that. What does this toolkit add? Well, we hope that it’s going to add the stuff that’s slightly less clear, the stuff around the edges of writing the manuscripts and sending it in. This is about how you actually open up a dialogue between people submitting work and the editors who are going to be considering it. The toolkit has some really crunchy things in it such as, don’t forget to write your papers so that they actually tell a story and they focus on readers and editors and reviewers rather than on regulators, for instance. So there’s some really nice information in the toolkit on how to provide editors and reviewers with what they need and also on how to communicate with them at all the stages of a manuscript going through the peer review process. There’s also some good guidance on how to select the right journal in the first place so that you don’t waste everyone’s time, including your own.
We hope that toolkit will increase the confidence of publication planners, medical writers, and industry investigators and make them feel it’s okay to talk to editors and they don’t have to kind of pretend that they haven’t been involved in some way. It’s okay to say, “I’m the person handling this submission and I’m acting on behalf of the investigators and this is my role.” We hope that this will really help.
Dan: I’m sure it will. Bernadette, now that the toolkit is nearly complete, how will it be rolled out at the ISMPP annual meeting in April?
Bernadette: We’re very excited. With the support from ISMPP, the author submission toolkit will be made widely available through several media options. It’s going to be launched at an editor’s roundtable event at the annual ISMPP meeting, which will feature the journal representatives who worked on the working group to develop this toolkit, as well as MPIP co-sponsors. In addition, the toolkit will be made available on the web at www.mpip-initiative.org, which will also be linked to the ISMPP website, and a full publication will be available in the near future.
Dan: This has been an extremely informative podcast episode. Trish and Bernadette, I’d like to thank you for sharing your thought leadership and expertise on this topic today.
Trish: Thanks. I hope it was helpful to people.
Bernadette: It’s been wonderful to be involved.
That does it for this episode. For more information about ISMPP or MPIP, visit www.ISMPP.org. Make sure you register for the 6th annual ISMPP annual meeting held on April 19-21, 2010 in Arlington, Virginia. You can get to the registration page from the ISMPP website.
Finally, don’t forget to check out our other podcasts at PharmaVOICE.com/podcast.
Until next time, I’m Dan Limbach.
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