Over two days last week (17-18 January, 2017), around 250 delegates and exhibitors attended the 2017 European meeting of the International Society for Medical Publication Professionals (ISMPP) in London. The agenda was centred around the evolving role of publication professionals in a multi-stakeholder environment and included a keynote address, lively panel discussions, smaller roundtable case-study reports and interactive parallel sessions. The Publication Plan will post summaries of the plenary presentations from the meeting for those of you that could not attend, as well as acting as a timely reminder of the highlights for those that did. A summary of the first day of the meeting is provided below. A summary of the second day of the meeting can be found here.
Day 1: Tuesday 17th January 2017
2016: A year in review
After a welcome from Fiona Plunkett, Chair for the European Meeting Programme Committee, Martin D Delahunty (Nature Partner Journals) rose to the challenge of summarising an eventful year.
On a global scale, 2016 will be remembered as the year that saw the UK vote to exit the European Union, and Donald Trump defy expectations to win the US Presidential election. Delahunty commented on the uncertainty that these events have created for medical research and publishing. He cited as examples the question marks over the future location of the EMA headquarters (currently housed in London’s Canary Wharf), and the impact of Trump’s decision to appoint Tom Price, an opponent of the Affordable Care Act (‘Obamacare’), as the next US Secretary of Health. Delahunty stressed that the US election result and Brexit will also offer substantial opportunities, but commented wryly on Trump’s decision to appoint a known vaccine conspiracy theorist to chair a vaccine safety committee.
Continuing with the theme of US politics, Senator John Barrasso published a proposed amendment to the Physician Payment Sunshine Act in May of 2016. The amendment would exempt pharmaceutical companies from the need to disclose payments to physicians for Continuing Medical Education, medical journals and textbooks. The amendment has been broadly supported by medical societies in the hope that it will reduce bureaucracy and delays.
Within the publishing and medical writing industries, 2016 was marked by discussion of a number of key issues related to data sharing and transparency. The tone was set in January when the ICMJE published a proposal to make the sharing of de-identified individual-patient data compulsory within 6 months of publication. In August, US Senator Elizabeth Warren wrote a piece in the NEJM supporting the ICMJE position and calling for increased sharing of data. In November, Ben Goldacre argued that his ‘TrialsTracker’ software was unable to find published data of any form for a substantial proportion of registered clinical trials. Others were quick to respond that many of the results had been published in places not searched by TrialsTracker, most notably on pharmaceutical industry websites.
An article in the BMJ generated debate around the prevalence and place of ghostwriting in publications sponsored by the pharmaceutical industry, while an analysis in ‘Medical Writing’ identified a 44% reduction between 2005 and 2014 in unacknowledged medical writing support among members of the European and American Medical Writing Associations. Finally, a study in BMJ Open was mentioned, which helps to demonstrate the value of professional medical writers. The study found that medical writing support is associated with increased quality of randomised-controlled trial (RCT) reporting, both in terms of language and adherence to CONSORT guidelines.
Multiple stakeholders and data disclosure through peer-reviewed publications
This interactive industry-based panel session provoked valuable discussions among the faculty and meeting participants, and highlighted some key challenges and future directions in data disclosure. The panel comprised Chris Rapier (Merck KGaA); Nicole Rapior (Boehringer-Ingelheim); Siobhan Southam (AstraZeneca) and Christine Vanderlinden (GSK Vaccines), and was chaired by John Gonzalez (Solanum Medical Communications Ltd).
Good Publications Practice 3 (GPP3) recommends that “findings from all clinical trials (including noninterventional studies involving human participants) should be made public, ideally by publication in a peer-reviewed journal”… “regardless of whether the findings are positive, negative, or inconclusive or whether the studied intervention is investigational, is licensed, or has been discontinued or withdrawn from the market”. While all panel members confirmed their view that publishing clinical data in peer-reviewed journals represents the optimal approach best practice, faculty members and delegates alike identified some potential hurdles to achieving the ambitious, but valuable goals of GPP3. Through discussion and debate the panel and ISMPP audience identified a range of solutions to such challenges, providing a way through to peer-reviewed data disclosure, even in less-than-ideal circumstances.
|Publication challenge||Potential solutions|
|Data now superseded by a larger study||Publish both data sets in a combined publication, clearly identifying both trials|
|Positive, confirmatory data/data lacking novelty||Select appropriate target journal; use open access journals|
|Negative data||Less difficult to publish than previously; some specialist journals exist; manage author expectations of journal choice|
|Local studies||Global publications policies apply to local offices|
|Studies funded by “hands off”, unrestricted grants||Include commitment to publish in contract; follow up with investigator|
|Definition of ‘medically important’ data||Publish all clinical data; consider all clinical trials to be ‘medically important’ as standard|
|Health Economics publications||Intra-company education, including on GPP3; medical review of publications; consistent and/or combined publication plans and processes|
|Tracking of compliance with publications policies||Potential area for development. Some companies conduct internal compliance checks, but do not publish results|
|Author expectations of target journals||Discuss with authors at project outset; identify a second and third choice at the beginning of the project; submit a pre-submission enquiry; express intent to publish at project outset|
|Access by primary healthcare professionals||Publish in an open access journal|
|Access by non-native English speakers||Include a lay summary; present at local level; provide local medical information|
Good Publications Practice 3 (GPP3) goes on to state that “not all studies produce publishable data. In such situations (for example, when the data are of limited scientific or clinical value or in the case of multiple journal rejections), posting results on a public Web site, trial registry site (for example, ClinicalTrials.gov, or the European Clinical Trials Database [EudraCT]), or data repository may be an option for disclosure”
To this end, panel members confirmed that, in addition to the above repositories , they also utilised or were investigating numerous other platforms for data distribution, such as company websites and scientific congresses. Meeting delegates cited some favourable experience of open publishing platforms such as F1000, in which peer review is conducted by website members after publication. However, panel experience of such platforms was limited. An alternative method for enhancing data disclosure was the use of digital supplementary materials, a topic of enthusiastic discussion among the panel. With some panel members already actively exploring these as a way to widen the circulation of clinical data and thus improve transparency, others were building such materials into their publications plans or considering their future use.
Sharing patient-level data: what are the implications?
The second panel discussion focused on the proposal from the International Committee of Medical Journal Editors (ICMJE) to make it a requirement for authors of publications reporting clinical trials to share the de-identified patient-level data underlying the results no later than six months after publication. Faculty for this session included Dr Dan Bridges (Nucleus Global [moderator]), Dr Stuart Spencer (The Lancet), Chris Carrigan (University of Leeds MRC Bioinformatics centre), Dr Fiona Godlee (The BMJ), Dr Philip J. (PJ) Devereaux (McMasters U), Dr Slavka Baronikova (Shire International GmbH) and Marie-Claire Pickaert (EFPIA).
The session opened with each panellist sharing their opinion on the benefits and risks of the ICMJE proposal: Fiona Godlee began by describing the underlying problems this proposal aims to solve and described the steps that have been taken to improve transparency over the last 15 years. Fiona outlined her viewpoint that clinical trial data should be available in summary form on public databases rather than through journals, which she considers an outdated format for this type of information. Individual patient data could then be made available for third party scrutiny upon legitimate request.
Slavka Baronikova followed to give her views from a pharma perspective and described how many pharma companies are currently happy to share patient-level data for legitimate research purposes, as long as patient consent has been given. The guiding principle for sharing of these data is patient privacy as, ultimately, it is the study sponsor who is responsible for both the patients and their data.
Marie-Claire Pickaert believed that the panel were generally all in agreement that there was value in allowing access to patient-level data, but a solution to how this can be achieved for the benefit of all parties was still required. Marie-Claire agreed that patient privacy will play a pivotal role in this, pointing out that data protection regulations to be implemented in 2018 could carry criminal charges for anyone found to be in breach of these rules.
Chris Carrigan agreed that there were considerable gains to be had from using patient-level health data, but doing so without listening to the views and voice of the patients will lead to trouble. Communication with patients, the public, and the media about how these data are to be used and why is vital. Chris explained that poor communication would simply create worry and concern among patients, and increase the likelihood of them opting out of sharing their data.
As a clinical trialist, PJ Devereux voiced a number of concerns around the ICMJE proposal, which have been published in detail previously in the New England Journal of Medicine. Firstly, as over 30,000 clinical trials are carried out each year, the costs associated with complying with the proposal would not be trivial in terms of both money and time, and will likely direct resources away from running trials. There may also be other unintended consequences such as delays of primary publications, spurious publications of secondary analyses, and fewer investigator-led trials.
Stuart Spencer also had some strong opinions on the proposal believing it to be potentially harmful (referring to the statements made by PJ Devereux), ineffective, and unnecessary. He also had issues around how the ICMJE have gone about the proposal, saying there had been a lack of debate involving the pharmaceutical industry, regulators, trialists, editors, the public, and other interested parties.
The faculty concluded that a consensus process was needed to determine the best way to achieve efficient and appropriate sharing of patient-level data. This will require an open discussion which brings together all relevant stakeholders in order to allow all sides of the debate to be heard.
Four short parallel sessions were held on the following topics. Participants could attend two of the four sessions:
- Scientific Communication Platforms: Best Practices, Challenges and Insights
- Data Transparency Update: The European Perspective in a Global Context
- Transfer of Value: The European Perspective
- The Learning Room: Essentials of Healthcare Communications for New Professionals
Speed research presentations
In the Speed Research session, six ISMPP members were invited to present their research. The session was chaired by Ryan Woodrow (Aspire Scientific).
Steve Smith (from Is LifeScience) presented findings from an investigation into publishing of market research studies. Focussing on rare diseases, a database of a healthcare market research organisation was analysed. The majority of market research studies were commissioned to better understand the patient pathway, to assess treatment impact or experience, to understand a disease and its management, or to identify unmet needs. All studies identified suggested actions related to patient experience of disease or treatments. In the same rare diseases, journal articles were identified on PubMed within the same timeframe. However, the focus of these publications – principally, treatment efficacy or safety, pathophysiology or biochemistry – differed greatly from the real-world experience information uncovered by the market research studies. Steve Smith stated that publication of market research studies could have a positive impact on medical practice, however these studies are rarely published.
Martin Neuner-Jehle from Sincope presented a new modelling tool designed to prospectively assess the impact of a communication plan. To achieve the maximum effect from a communication plan there needs to be a cognitive, social and emotional impact. The tool – Interactive Modelling tool for PlAnning of scientific CommunicaTionS (IMPACTS) – measures the cognitive, social and emotional impact of each planned communication (abstract, manuscript etc) over a defined period of time. It allows the planner to see when gaps in communication may occur throughout the timeline of a communication plan.
Publication of unplanned analyses has risen exponentially over the past few years. Matthew Booth from Parexel International discussed his research into whether there is sufficient guidance on the publication of such analyses. Searches of the EQUATOR Network database, industry and society publishing sites, medical journal guidelines, regulatory authority guidelines and pharmaceutical company publication guidelines revealed that there is a paucity of publicly available guidance to support transparent publication of unplanned analyses. Such guidelines would be beneficial for encouraging consistent and appropriate methodology, timely publication, clear identification of publications as unplanned/post-hoc outputs, transparency and the publication of studies regardless of outcome.
There is much guidance about information that must be included in a conference abstract. However there is little evidence regarding the factors which make an abstract more likely to be selected for oral presentation. Simon Foulcer of Costello Medical Consulting Ltd discussed a study investigating the factors that may affect whether an abstract is selected for an oral presentation. The study focused on three key variables – the number of outcomes reported, whether the abstract included a figure or table, and the funding source. The team discovered that abstracts selected for presentation as a poster, and industry-sponsored abstracts, reported significantly more outcomes in the results section (both p<0.05). Industry-sponsored abstracts were less likely to be selected for oral presentation (no statistics given). Abstracts selected for poster presentation were more likely to include a table and less likely to include a figure than those selected for oral presentation (no statistics given). The authors concluded that including an optimal number of outcomes in an abstract may increase the chance of selection for oral presentation. However, it was acknowledged that the dataset was small and that further investigation is warranted
Simon Page presented information about a scientific internship program running at Costello Medical Consulting Ltd. While medical communications companies typically look to recruit staff with some prior experience, applicants without any experience are finding it difficult to “get a foot in the door”. The paid internship program has proved popular, and in 2015 the program had an application success rate of 1.7% (8 out of 492 applicants), with 75% of successful candidates being undergraduates. A large proportion of interns (37%) remained with the company as permanent employees or ongoing interns and satisfaction with the program is high. It was concluded that scientific internships provide benefits to both the intern and the company, offering a vital entry route into the industry and providing valuable resource for communications agencies.
The final talk in this session was given by Santosh Mysore (GSK). Santosh discussed a toolkit that has been developed to support authors in selecting appropriate target journals. Sixty-three manuscripts containing data from GSK-sponsored clinical studies were selected and scored based on trial outcome, novelty and public health impact (with some positive or negative weighting as appropriate). Score was plotted against the impact factor of the journal to which the manuscript was submitted. There was a correlation between score and impact factor for manuscripts that were accepted, but no correlation for rejected manuscripts. Using this tool, a suitable range of impact factors can be identified. This can allow a pool of potential target journals to be narrowed down, with subsequent selection of 3–5 journals according to target audience, open access options, publication timelines, language and journal requirements. These suggested target journals can then be proposed to the authors. This tool may help to increase acceptance rate and therefore reduce burden on authors, writers, editors and sponsors, as well as improving timely publication of clinical trial data.
In this lively session, the moderators Fiona Plunkett (Articulate Science) and Jackie Marchington (Caudex) presented evidence to try and refute three popular ‘myths’ that commonly abound with medical publishing and the pharmaceutical industry. Following each presentation, the ‘judges’ Stuart Spencer (The Lancet) and Martin Delahunty (Nature Partner Journals) gave their opinion on whether the weight of evidence ‘Busted’ the myth, or whether the assertion was ‘Plausible’ or ‘Confirmed’.
Myth 1: Professional medical writers introduce bias. Research evidence was presented showing that publications involving professional medical writers are more likely to conform to CONSORT standards, are of a higher quality of written English, and are associated with fewer retractions due to misconduct. Additionally, publications of industry-related trials, many of which involve medical writers, are less likely to receive peer review comments related to poor study design or inappropriate statistical analyses versus non-industry trials. Commenting on the evidence, Stuart Spencer felt the statement was Confirmed, while Martin Delahunty believed it was Plausible, opinions that suggest more work is needed to counter the bias claim.
Myth 2: Half of all clinical trials remain unpublished. This myth stems from the AllTrials campaign, which, it was reported, incorrectly cites a systematic review of bias published in 2010 by Song and colleagues. Additionally, Trials Tracker cites a 45% non-disclosure rates based on the reporting of results in ClinicalTrials.gov, which does not consider data disseminated via for example abstracts, full manuscripts, or on company websites. Citing a 2017 publication, 90% of company-sponsored trials related to new drugs approved in Europe in 2013 were reported within 12 months of regulatory approval or trial completion (the overall disclosure rate was 93%). Both judges felt this myth was Busted.
Myth 3: Reporting industry funding: damned if you do; dammed if you don’t. The transparent disclosure of industry involvement in the design and conduct of a trial, and of funding of medical writing support, are integral to GPP3, ICMJE, ISMPP Code of Ethics and other principles of ethical publishing practices. However, evidence was presented that physicians are more skeptical of results of industry-funded trials, as are journal reviewers of the financial relationship between authors and pharmaceutical companies, while time in peer review is increased if a paper declares medical writing support. Stuart believed the myth was Busted (meaning the benefits of full disclosure always out weight any negatives), while Martin felt it was Plausible.
When asked which ‘myth’ needed more efforts to counter any misconceptions, the leading vote by the audience was for myth #3 (45%), followed by myth #2 (34%) and myth #1 (21%).
Day 1 ended with a networking reception allowing time for delegates to view the posters presented by ISMPP members.
To see the summary of Day 2 of this meeting, click here.
By Aspire Scientific, a boutique medical writing and publication planning agency led by professionals with at least a decade of medical writing experience and supported by PhD-educated writers and academics at the forefront of their specialist fields.