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Biopharmaceutical Section Cracks Code on Cross-Sector Collaborations

1 November 2020 No Comment
The ASA boasts 29 sections and 10 interest groups that often serve as their members’ professional “home away from home.” While ASA sections and interest groups aim to foster community, the ASA Biopharmaceutical Section may have discovered the secret to catalyzing productive collaborations that impact multiple sectors. Recently, Richard C. Zink, vice president of biostatistics at Lexitas Pharma Services, took the ASA Statistical Partnerships Among Academe, Industry, and Government (SPAIG) Committee behind the scenes to see how the Biopharmaceutical Section cracked the code on productive cross-sector collaborations.

    Michelle Shardell and Fanni Natanegara, SPAIG committee

    Can you describe how the collaboration started?

    In 2013, the executive committee of the Biopharmaceutical Section developed a committee, process, and template to help foster scientific working groups (SWGs) within the section. The goal was to bring statisticians together from across industry, academia, and government to research challenging problems in medical product development. This effort was initiated in response to a proposal submitted to the executive committee to form a SWG for safety. The working group was approved as a pilot of the SWG program in 2014.

    Statistical Collaboration Is Essential
    Collaboration is essential in our statistics profession, and ASA seeks to encourage and recognize outstanding collaborations. In addition to providing a professional networking forum, the ASA offers professional development and leadership trainings crucial to building and maintaining collaborations. The ASA Biopharmaceutical Section recognizes the value of cross-community efforts and has successfully developed a sustainable collaboration framework to advance statistical and regulatory science while leveraging the expertise of their members.

    The safety SWG focused their initial efforts on two manuscripts for statistical issues related to cardiovascular outcome trials for patients with type II diabetes mellitus published in Statistics in Biopharmaceutical Research. After submitting this second paper in mid-2016, the group decided to focus on the strengths and limitations of the various data sources used to evaluate patient safety throughout the medical product life cycle. However, summarizing the data sources alone paints a somewhat incomplete picture. How these data are collected, the design (or lack thereof) of the experiment from which they are collected, and the quality of the measurements themselves play a key role in how the data is analyzed and, ultimately, how the analysis is interpreted and communicated. Therefore, detailed descriptions of the data, design, and appropriate analysis methods were required to fully characterize the data sources and their specific challenges to understanding patient safety.

    Initially, the plan was to write a single manuscript, but it became clear that a single manuscript would be woefully inadequate to describe our research in sufficient detail. Four manuscripts comprised a special section of the March 2018 issue of the Drug Information Association (DIA) journal Therapeutic Innovation and Regulatory Science (TIRS); they were the result of more than a year of research, writing, and revision by a group of 10 statisticians.

    What helped people to get and remain engaged in the collaboration?

    The first item that helped was a delegation of responsibility. With four manuscripts, a different individual was selected to lead writing efforts for each manuscript. These leads were responsible for a substantial portion of the writing. However, other team members wrote individual sections of manuscripts that aligned with their experience, and the manuscript leads were responsible for maintaining timelines and incorporating text into drafts to find a common voice. Once mature drafts were available, the entire team reviewed and provided comments.

    The second item that helped was frequent communication among the team. For most of the time, the team met biweekly and individual manuscript teams described and presented progress for the manuscripts. This kept the writing effort front-and-center for everyone.

    Finally, organization was key. To have a consistent format, a team-generated Word template was created, and the first step was to generate a manuscript outline within the draft. This allowed the team to assess whether the outline was complete and gave others the opportunity to volunteer to write various sections.

    What are the major benefits coming from the collaboration that would not have otherwise happened?

    The group benefited from the breadth of knowledge and experience of 10 individuals for generating the most complete manuscripts. Individual topics could be written in more detail more quickly since individuals most familiar with the literature could begin writing immediately. Further, given that the team was made up of individuals from the US Food and Drug Administration, multiple pharmaceutical companies, and a software company, there were a variety of perspectives on data and analysis to which people were exposed. This collaboration also provided speaking opportunities at major conferences to present the research of the SWG while providing visibility and engaging more junior members. Finally, it was an opportunity to develop friendships with individuals around the country.

    What have been the most rewarding and most challenging aspects of the collaboration?

    The published special section is certainly rewarding on its own, but this special issue has served as a foundation for research of the safety SWG in the years since it was published. Further, some of the members of the group have been asked to peer review manuscripts on safety or data visualization that have referenced the work of the SWG. The safety SWG was deliberate in reaching out to the larger multidisciplinary community due to the topic; it was a key reason for the selection of TIRS for publishing the special section and proposing scientific sessions at DIA conferences. This outreach may be partially responsible for the dozens of statisticians, and even some clinicians, participating in the safety SWG today.

    There were two big challenges. First, the interactions of group members were all conducted virtually as we were spread out geographically, so frequent interaction was important. There are tools and technologies today that make it much easier to meet and interact in a virtual environment; however, there are challenges in terms of what software people are able to use to communicate and produce work.

    One challenge the safety SWG has struggled with and still struggles with is the ability to store documents at no cost where everyone has access with the added ability to jointly author documents in real time. Some companies do not allow access to Google Drive or Docs, and this significantly limits how the team can conduct this virtual work. We have researched this issue at various times and have yet to find a single system where all participants have access.

    Second, everyone has day jobs. This can interfere with peoples’ ability to participate in calls or provide work by a given timeline. This should be expected for any volunteer efforts.

    What advice would you give to individuals and organizations looking to be more collaborative? Specifically, what advice do you have for other ASA sections in setting up productive working groups analogous to the ASA Biopharmaceutical Section?

    We think other sections could and should develop similar frameworks to support SWGs. It would be important to start with a pilot project (as safety was for the Biopharmaceutical Section) on a topic that is not being researched by other working groups or professional organizations and with a charter that defines and establishes clear goals and timelines for researching, writing, and presenting. Further, section leadership can help identify initial SWG co-chairs and members. The visibility and success of this pilot SWG can inspire others to submit ideas to the section to form other SWGs. The section can provide feedback on the completeness of the proposal and suggest other individuals who may be interested in participating.

    The section can also provide part of its website to communicate the efforts of their SWGs and give greater priority to conference sessions or offer webinars for SWG topics. The executive committee of the Biopharmaceutical Section is exploring other ways our section can assist our SWGs. To help drive this process, it is recommended that individual sections form dedicated committees to oversee the development of SWGs. These committees should also engage in periodic (e.g., annual) review of each SWG to assess the progress of the group relative to the charter.

    The authors gratefully acknowledge the feedback from Bruce Binkowitz, 2020 Biopharmaceutical Section Chair and initial Chair of the SWG Committee, and Qi Jiang and Olga Marchenko, proposers and initial Co-Chairs of the Safety SWG.

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