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While many projects that biostatistics CROs tend to get involved with are related to clinical trials, sponsors also often need for analysis and statistical input to support the publications strategy arising from the research.

Peer-reviewed publications are crucial for supporting transparency around the outcomes from the clinical trials, forging collaborations and advancing scientific endeavour.

Together with my Veramed colleagues, over the last few years, I have worked on a substantial publications project that has produced over twelve papers so far. In this blog, I’ll share some of the key lessons have learned from participating in this project and how the skills we have developed can benefit other projects.

The project was a large respiratory event-driven trial involving over 16000 patients.  With such an extensive study, there was an especially rich wealth of demographic, biomarker and other disease-related data available which had the potential to yield positive insights for future scientific exploration.  So, after achieving regulatory approval, the sponsor wanted to explore further analyses to fully maximise the data and contribute to the body of research in that therapy area. With that in mind, our client put together a committee of key opinion leaders to direct the publications strategy.  All leading clinicians within the field, they brought a wealth of ideas and a firm grasp of what was achievable with statistical analysis using the data from the trial.

Along with the sponsor’s in-house statistician, and with the backing and support of the broader Veramed team working behind the scenes, I attended the steering committee meetings to represent the statistical point of view.  Together, we explored the various research questions of interest.  Then, once we agreed the most promising lines of enquiry, the statistics team developed analysis plans for each project and produced outputs to help answer the research questions.  The team of clinicians then used the analysis to inform the series of publications.

Lessons learned

Meeting management

These steering committee meetings were much more formal than the kind of routine internal and external meetings I had previously experienced.  It was a significant investment for the sponsor to run them and challenging to coordinate the diaries of so many senior clinicians.  In this context, it was, of course, essential that we got the maximum value out of the meeting time.  Therefore, we had to meticulously prepare and manage a fixed agenda, clearly define the goals and ensure that we were sufficiently prepared to fully benefit from the opportunity of having this exceptional group of experts all together in one place.  Nothing must be missed in this situation – if you leave these high-profile meetings having forgotten to ask a crucial question, then the opportunity for exploration could be lost altogether. 

How can this lesson benefit other projects?

In general, meeting management is an art that often doesn’t get the focus it deserves.  Most of us at some time will have sat through lengthy meetings that had no agreed plan or documented actions and left us unclear about the purpose.  By treating every meeting with attention and importance, we can significantly improve efficiency and build better communications to drive projects forward.

Project management 

The world of publishing research is distinct from delivering a package of analysis for a clinical trial, with more fluid deadlines.   For this project, that involved exploring various research questions and submitting the results for publication in journals and conferences. Often, at least for the journal publications, we were driven more by internal deadlines than an external mandate for submission.  Of course, the other time-sensitive aspect was ensuring that our publications were ahead of any similar papers in the works by other organisations. 

How can this lesson benefit other projects?

An assertive approach to managing projects and deadlines by organising internal deadlines and your personal timelines can reap rewards when it comes to keeping projects of any kind on track.  

Influencing skills

This project was unusually high profile in the sense that it involved working with many extremely senior clinicians and liaising with them as the analytical professional alongside the sponsor’s statistician. I found this a very enriching experience from a scientific point of view. I appreciated the different perspectives of the clinicians- all of whom also had an excellent understanding of statistical concepts.  As statisticians, our role within the team was well respected as international journal guidelines stipulate that any paper submitted needs to have analytical input. Nevertheless, there were, of course, times when, as the statisticians, we had to use our communication and persuasion skills, and sometimes say ‘no’ when a proposed analysis just wasn’t viable.  Developing the ability to assert influence was a key takeaway for me from the project.  

How can this lesson benefit other projects?

Nowadays, as statisticians, we are increasingly called on for our opinion as well as our analysis skills.  The ability to navigate discussions with senior stakeholders is a vital skill when it comes to managing any project. Having the confidence to say ‘no’, is a sought after quality among CROs in a world where vendors are often so keen to please they fail to push back – even when doing so would benefit the outcome.  

Developing deep domain knowledge

One of the unusual features of this project was the fact that it was long term and involved many different aspects of the same indication and dataset.  Because of this, I developed strong subject matter knowledge within the domain, thanks to the in-depth discussions with the clinical stakeholders.  As well, to understand the publication environment and landscape, the Veramed team spent time searching PubMed and other sources for previous publications in the same therapy area to inform our research questions and analysis.

How can this lesson benefit other projects?

Having a research mindset and developing domain knowledge benefits our work across all types of project.  In particular, therapy knowledge is invaluable when we are called upon to design a clinical trial. At Veramed, to support this way of thinking, we run a journal club for our statistical team. Within this group, we share innovative research papers to help broaden our horizons, boost our knowledge and add additional value to our clients. 

Publications research is a highly rewarding area and one where specialist statistical input adds an enormous amount of value.  This high-profile project also equipped our team with well-honed project management, influencing and research skills to apply in a range of customer projects. 

Are you carrying out a Publications Project? Download our Publications Project Success Checklist to keep your project on track.

Nick Cowans