While randomised clinical trials are often considered the gold standard of medical research, data generated from other settings can provide highly valuable findings and should be considered when developing a publication plan. Following her presentation at the 2021 International Society for Medical Publication Professionals (ISMPP) West meeting, The Publication Plan talked to Valérie Philippon, Head of Global Publications at Takeda, to find out more about the benefits of including non-clinical trial research in publication strategies.

At the ISMPP West meeting in October 2021, we heard how data from outside clinical trial settings – such as observational research and health economic analyses – can add value to a publication strategy. What gaps can these data fill and what are the benefits of incorporating them into publication strategies?

“To develop an impactful and complete publication plan, one has to consider all types of data: not only the clinical data but also preclinical, heath economics and outcomes, and real-word evidence. Doing an in-depth gap analysis of a particular disease area is a really important first step in developing a publication plan, followed by identifying all relevant audiences and mapping out data availability. Clinical data are of course designed to answer key questions about a particular intervention, but not all medical questions can be answered by randomised clinical trials, since not all populations can be studied at once. Observational studies can shed light on many disease parameters and outcomes research can help understand how patients experience health care interventions. These findings should be incorporated into publication plans.”

“To develop an impactful and complete publication plan, one has to consider all types of data.”

In your experience, what are the most important things to understand about these types of datasets? How do they differ from clinical trial data?

“Understanding the differences between controlled trials and observational studies is key to interpreting data and comprehending the limitations of the studies. In clinical trials, individuals are assigned to receive one or more interventions (or no intervention) so that the effects of the interventions on biomedical or health-related outcomes can be evaluated; whereas observational study participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions. One limitation of observational studies is selection bias, as individuals in a database or study are not randomly assigned to an active or control group, but generally have already been diagnosed with the disease being studied and/or are receiving a specific treatment, making any attempt to control variables difficult. However, such studies can be very large and span multiple years leading to rich datasets. The two types of study are complementary and should both be included in publication planning.”

Are there any best practice tips you could share on how to incorporate value communications into a publication plan?

“A coherent value communication, scientifically driven and relevant to each audience, should be developed early and updated frequently.”

“A coherent value communication, scientifically driven and relevant to each audience, should be developed early and updated frequently as more data are generated. Understanding the current landscape, identifying the needs of each audience and mapping out data availability are all key components to take into account while building a publication plan incorporating strategic data release.”

We also heard how the target audiences for value communications may include decision makers, payers, and patients, in addition to healthcare practitioners (HCPs). How do the needs of the end-users differ and how should that impact the publication planning approach?

“A publication plan must target all relevant audiences, in terms of type of communication, venue and timing. HCPs need safety and efficacy information in order to inform their diagnostic and treatment decisions, while payers need economic and outcome data to help them with reimbursement decisions. Understanding the payers’ needs is critical for a company to ensure that key information is communicated early enough for its innovation(s) to translate into patient value and access.”

There’s growing recognition of the importance of making medical publications accessible to a wider audience through instruments such as plain language summaries (PLS). What are your perspectives on how the industry can innovate and adopt policies to achieve this goal? What should we as publication professionals be doing to communicate more effectively with a non-HCP audience?

“Scientific literature is by definition technical and difficult to understand for non-specialists and more can be done to make scientific and medical research more accessible and inclusive. Plain English and lay summaries of peer reviewed medical journal publications are intended for everyone engaging with medical research, such as all HCPs (MD and non-MD, specialists and general practitioners), patients, patient advocates, caregivers, and the general public. More and more PLS are developed alongside medical publications and indexed in PubMed, but we can still do better at consistently developing PLS, and agree as an industry on their format (eg, length, inclusion of infographics), the process involved in writing PLS and how to make PLS discoverable.”

“More can be done to make scientific and medical research more accessible and inclusive.”

At the ISMPP EU 2022 meeting you co-authored a study on the accessibility of pharmaceutical industry-sponsored research. Do you think universal open access for pharma-sponsored research is an achievable goal? What’s the current approach to open access at Takeda?

“As a commitment to transparency and to open science, Takeda requires the submission of all Takeda-supported research manuscripts to journals that offer public availability via open access, allowing the public to obtain free, unrestricted online access to Takeda’s research promptly following publication. On a personal level, I believe that universal open access for pharma-sponsored research is a very attainable goal that all pharmaceutical companies should prioritise.”

“I believe that universal open access for pharma-sponsored research is a very attainable goal that all pharmaceutical companies should prioritise.”

You have also been involved in research on the utilisation of preprints by the pharmaceutical industry, which to date has been relatively limited. Do you envisage greater use of preprint servers by the industry in the future? Are there any fundamental barriers preventing the pharma industry from using preprints?

“As we demonstrated in our ISMPP posters (Current trends in pharmaceutical industry-affiliated preprints, Wieting et al, presented at the 2021 ISMPP European Meeting and Current trends in pharmaceutical industry-affiliated medRxiv and bioRxiv preprints, Wieting et al, presented at the 2022 ISMPP European Meeting), only a small proportion of preprints are affiliated with pharmaceutical companies and even fewer have a pharmaceutical employee as first or corresponding author. There is a reluctance to share clinical data in preprint form as some companies feel that preprints fall outside of the scientific exchange, so more guidance from regulatory bodies would be helpful.”

“Some companies feel that preprints fall outside of the scientific exchange, so more guidance from regulatory bodies would be helpful.”

Valérie Philippon is Head of Global Publications, Takeda, and can be contacted via valerie.philippon@takeda.com or LinkedIn.

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