医学写作

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战略出版规划

Costello Medical was approached by a client to assist with the development and implementation of a Strategic Publications Plan for a novel therapeutic agent, meeting both global and regional publications needs and spanning multiple indications.

Challenges and considerations:

• The agent was at different lifecycle stages within different indications, ranging from clinical development to post-approval.
• In the build-up to launch in a new indication, rapid disclosure of the primary clinical trial data was necessary, along with a range of publications to support launch across multiple geographies.
• Owing to the multiple indications and wide geographic spread, a large number of client stakeholders needed to be consulted in the development of the plan, whilst maintaining consistency with the Strategic Communications Platform.

Costello Medical’s Approach:

1. Facilitation of the planning process
   We first developed a step-wise, iterative, planning process, leading from the initial stages of idea generation through to generation of a fully endorsed Strategic Publications Plan. The approach taken was tailored to the specific needs of the client: designed to capture the requirements of all stakeholders and ensure alignment between parties. Ultimately, this resulted in a plan that met everyone’s needs, whilst being as streamlined as possible.We developed custom-made templates and materials to facilitate the process, as well as organising and leading calls and meetings to keep the project on-track and ensure clarity in the process.
2. Creation of the Publications Plan
   When creating the publications plan, we considered the different lifecycle stages of the product and the publication requirements for each. The final plan was based on upcoming data from a range of sources, including primary clinical trial data, post-hoc analyses to address specific publication needs, real-world evidence and reviews. By recognising the audiences we needed to reach, identifying the key congresses in the field and assessing the timelines for data availability, we were able to maximise the impact of each individual abstract and manuscript.
3. Implementation of the plan and ongoing support
   Throughout the year, we continued to work closely with the client to monitor and carry out the publications plan. We proactively contacted the client to initiate congress work and manuscripts ahead of the planned submissions, developed the publications themselves, and provided regular updates on the overall status of the plan through both trackers and graphical summaries. Regular Publications Team meetings were established to ensure the flow of information across the team.We understand that even the best laid plans do change, and we are happy to accommodate and implement updates as needed. We communicate any changes throughout the team, and take responsibility for ensuring that these are fully endorsed by the Publications Team and compliant both with Good Publications Practice and the client’s own internal SOPs.

撰写高影响力学术文章

Costello Medical was asked to support the development of a high impact article targeted for submission to a special issue of the Lancet. The trial results were to be released very close to the journal’s submission deadline and so it was necessary to work to very tight timelines, completing and submitting the manuscript within 12 weeks of the results being made available.

As this manuscript was produced prior to CSR development, a cross divisional Publications/Medical Affairs team worked closely with the client to ensure key messages were accurate and aligned across all medical materials. Team members from the Publications division attended the study steering committee to ensure full alignment with the client and KOLs. During the manuscript’s development calls were held with all authors to address any comments and ensure all authors were fully aligned with the manuscript’s content. We also held internal alignment meetings to ensure all feedback received from the client and authors was relayed to the cross divisional team working on the study.

In parallel with the development of the manuscript, we developed an abstract which was to be submitted to an international congress. During the finalisation of the abstract, the authors requested a second abstract reporting results from a number of exploratory and post-hoc study results. Both abstracts were completed and submitted, with the primary abstract selected for an oral presentation at the plenary session of the congress, and the second abstract selected as a poster presentation.

During the congress the publication team provided onsite support to the client and KOLs. Prior to congress we liaised closely with the editorial team at the Lancet, organising the production of a number of reprints that were delivered to the congress and made available during the plenary presentation. Onsite, we provided KOL support, managing the slide review with the presenting author and ensuring the presentation was finalised and uploaded to the congress system.

撰写白皮书

We were approached by an international think tank to develop a peer-reviewed white paper authored by a group of 13 rheumatology key opinion leaders (KOLs) from around the world, highlighting global challenges and opportunities for clinical care, education, and research. We began by conducting a preliminary literature search on these key topics with respect to rheumatic and musculoskeletal diseases (RMDs), and developed a series of questions for the KOLs to consider. We collected feedback via email and telephone interviews and in collaboration with our key client contact, we developed an agenda for a one-day expert panel meeting.

The face-to-face meeting enabled us to work closely with the KOLs to develop a clear framework for the White Paper, and to agree on key messages for policy-makers. Following the meeting, we conducted a more focused literature search to provide further evidence of key topics discussed and developed a full draft of the White Paper. Our rapid delivery of this draft to the KOLs for review kept up momentum from discussions at the expert panel meeting. The KOLs were quick to review the draft publication, plus 1 further draft, and a final version of the White Paper (approved by all 13 KOLs) was submitted to the target journal just 2 months after the face-to-face meeting. Within 1 month of submission, the White Paper was accepted for publication in our first-choice target journal. In response to our pre-submission enquiry, the journal arranged for an editorial piece to be published alongside the White Paper, enhancing the visibility of the article to rheumatology experts and policy-makers.

Our fast turnaround times, careful planning, strategic input and close collaboration with the KOLs throughout the development process guaranteed the delivery of a high-quality publication, within pre-agreed timelines, that surpassed client and author expectations. The success of this project has led to the development of a second White Paper focusing specifically on RMD education; one of the key challenges highlighted in the original article.