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At ISS, we bring the integrated approach to life by ensuring that our teams work seamlessly together, particularly where their expertise and fields overlap. It’s through this collaboration that the "magic" happens – transforming joint efforts into tangible value and results when leveraging clinical data. From developing a comprehensive clinical data strategy to conducting clinical studies, collaboration is the superpower we rely on and cultivate at ISS. Are you curious about what happens when a medical writer and a clinical project manager exchange insights on clinical data - and reveal which fictional character they’d add to their team to tackle the unique challenges of their fields? Then read on and get to know the ISS AG experts Kathrin Abegg, Head of Clinical & Scientific Affairs, and Julie Tantau, Head of Clinical Operations.

The Importance of Clear Communication and Alignment in Ensuring Accurate Data Collection

The Clinical & Scientific Affairs Team at ISS AG, with its Medical Writers, initiate the clinical evaluation process at an early stage (of the product development) to support the development of the clinical strategy. For the Clinical Operations Team, this preparatory work provides valuable inputs for the clinical investigation planning. The clinical evaluation process plays a key role in determining whether a clinical investigation is necessary and, if so, what data must be collected. Equally crucial for the latter is selecting a comparator – or deciding and justifying not to include one. This choice is critical in defining the specific data gathered during the clinical investigation.

The clinical evaluation process addresses key questions such as which clinical outcomes to assess, what to compare the device to (e.g., a well-established device or an alternative treatment/diagnostic option), and what constitutes acceptable or successful outcomes. These questions are primarily answered through systematic literature searches, which form part of a state-of-the-art (SOTA) assessment. This assessment evaluates device safety and performance in relation to the current standard of care and comparable technologies, if available. For the US market, another approach involves reviewing the evidence used to approve similar devices, including examples of competitor studies. However, it is uncommon to find complete study results published in clinical trial registries.

A critical step in the process is identifying the most frequently reported clinical outcomes related to performance, safety, and benefits, which then allows for establishing acceptance criteria for each outcome. While the communication channels between teams are open since the project's beginning, Julie and Kathrin agree that this is the stage where Medical Writers and Clinical Operations actively collaborate. Some outcomes may not be feasible to test in a clinical setting due to the influence of multiple (non-clinical) variables or the significant burden they impose on the study participants. Additionally, specific outcomes may require a sample size that makes a statistically valid study impractical, and more practical alternatives exist and should be considered. In such cases, an alternative parameter can be justified – one that is more straightforward and might lead to a simpler study design. This intersection between clinical and operational considerations highlights that there is often no absolute "right" or "wrong" solution. This makes it essential to understand precedent – what others in the field have done – and to be prepared to justify the rationale behind the chosen approach.

Ultimately, you must be able to justify your decisions and actions, providing a clear explanation of why and how the collected data was obtained.

Kathrin, could you share your best practices and recommendations for effectively searching for clinical evidence?

Inputs for the SOTA assessment primarily come from published literature, although other sources should also be considered. Conducting a literature search requires a systematic and comprehensive approach, balancing thoroughness with practicality to avoid retrieving an unmanageable number of publications. This structured approach helps ensure that the SOTA assessment is robust and aligned with regulatory and clinical expectations:

- Follow good practices for systematic searches and ensure all steps are well-documented.
- Perform scoping searches to identify and refine relevant search terms.
- Try to identify benchmark devices or appropriate competitors (if available).
- Develop comprehensive search protocols and validate them by confirming that relevant publications were captured.
- Use sources like the Cochrane database of systematic reviews to identify relevant quantitative outcomes and acceptance criteria.

 


When a Clinical Study is Needed: Aligning Strategy with Action

The Clinical Operations Team at ISS AG is responsible for making clinical investigations a reality. They take the insights and data needs identified by the Medical Writers, whose input is critical for designing an investigation tailored to a specific product and transform them into actionable plans. At this stage, the Clinical Project Manager begins planning the various aspects of the investigation to ensure its successful execution.

Conducting a clinical investigation is a significant undertaking that requires careful management due to the complexity and the many interconnected aspects involved, often accompanied by considerable pressure to ensure its success. Experience and a thorough understanding of the entire process are essential for managing the inevitable time pressure from sponsors. Only well-founded arguments can persuade them to follow the process without rushing. To support customers, Julie and her team created explanatory slides providing a detailed overview of a clinical investigation.  A profound process knowledge, patience, and strong organisational skills are the best practices for staying calm and focused during clinical investigations.

Sometimes, people are in a rush, have narrow tunnel vision, and just want to move forward and complete their studies. That‘s the moment to slow down and minimise the risk of jumping into an inappropriate study.

Julie, what are your best practices and recommendations when you realise the data collected in an investigation might be unsuitable?

The worst case is when you are already testing and realise the data is unsuitable. This is a pitfall into which sponsors can easily fall when they are too eager to start a clinical investigation without the proper preparation. Of course, there are still possibilities to fix these situations, but they are very much what we want to avoid. Therefore, we always make it clear to our clients that the interaction with Medical Writing and critical review of the clinical evaluation plan (CEP) and the study protocol is essential. Additionally, the considerations from the physicians with the day-in and day-out knowledge of the treatment and the device(s) in use are useful. They also have valuable input on the best way to test it.

 


Considerations of Common Challenges and Discussions

Collaboration and specialised fields often come with buzzwords that can evoke both positive and mixed reactions. Julie and Kathrin, for instance, hold differing perspectives on key topics such as budget, review and planning.

Budget

Budget

While estimating expenses is straightforward, conveying the value of early investments when clients are eager to start a clinical investigation can be difficult. So, budget discussions can be challenging, especially when the necessity of certain costs is questioned.

Budget

Budget

Budgeting for clinical studies is a complex task. These studies often involve large budgets, and costs can easily escalate if not carefully managed. Every step of the process requires close oversight.

Review

Besides the literature reviews we do as our main activity, the term review also refers to the process of clients checking the documentation we created and providing input on it. This is very important, necessary and useful; but it can sometimes be painful when we have mentally already finished a project.

Review

While reviews are a necessary practicality, they benefit from diverse perspectives, as it's easy to overlook details when repeatedly examining the same materials.

Planning

I thrive on moving from uncertainty to clarity through researching and outlining requirements, but I am less excited about detailed project planning. For those in clinical operations, a passion for planning and organising is essential, but luckily it's less critical for medical writers.

Planning

Planning is fun; I love planning! It’s very exciting to start a new study, and in the end, you will always be thankful that you have planned well and documented it.

   

Budget

Kathrin

While estimating expenses is straightforward, conveying the value of early investments when clients are eager to start a clinical investigation can be difficult. So, budget discussions can be challenging, especially when the necessity of certain costs is questioned.

Julie

Budgeting for clinical studies is a complex task. These studies often involve large budgets, and costs can easily escalate if not carefully managed. Every step of the process requires close oversight.



Review

Kathrin

Besides the literature reviews we do as our main activity, the term review also refers to the process of clients checking the documentation we created and providing input on it. This is very important, necessary and useful; but it can sometimes be painful when we have mentally already finished a project.

Julie

While reviews are a necessary practicality, they benefit from diverse perspectives, as it's easy to overlook details when repeatedly examining the same materials.



Planning

Kathrin

I thrive on moving from uncertainty to clarity through researching and outlining requirements, but I am less excited about detailed project planning. For those in clinical operations, a passion for planning and organising is essential, but luckily it's less critical for medical writers.

Julie

Planning is fun; I love planning! It’s very exciting to start a new study, and in the end, you will always be thankful that you have planned well and documented it.

 


Fictional Superpowered Teammates: Who Would Complete the Data Duo?

Handling clinical data is not magic, but certain skills - akin to magical powers – are certainly invaluable, particularly the ability to collaborate effectively. The success of a clinical study relies on strong teamwork. If fictional characters could join the ideal team, Kathrin and Julie have their picks: Kathrin would choose Sherlock Holmes, whose sharp analytical skills would be especially helpful in drafting conclusions and summaries. His ability to simultaneously grasp and connect multiple important aspects would be invaluable. Julie would enlist Santa Claus as a super recruiter, tasked with finding all the study participants required, persuading them to take part, and ensuring their consistent attendance for follow-up visits. With his comfortable sledge and ability to be everywhere when needed, he would undoubtedly be a big asset to the team.

Clinical activities are essential for demonstrating the safety and effectiveness of medical devices and in vitro diagnostics (IVDs). At ISS AG, Medical Writing and Clinical Operations work closely together to collect data while prioritising patient safety. Their extensive expertise is a critical asset to every project. The integrated approach at ISS AG is demonstrated daily through a collaborative mindset, the incorporation of best practices, and a pragmatic focus on achieving the required outcomes.

 


About The Experts


Kathrin, an experienced Medical Writer, joined ISS AG in 2017. She has a PhD in Veterinary Medicine from the University of Zurich and is proficient in scientific writing, research, and all aspects of medical writing.
Kathrin Abegg, PhD
Head of Clinical & Scientific Affairs
Julie, an experienced Clinical Project Manager, joined ISS AG in 2020. She holds a Doctor of Audiology degree and a diploma in clinical research, with expertise in all aspects of clinical research.
Julie Tantau, AuD
Head of Clinical Operations

 


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