The central challenge of Joint Clinical Assessment (JCA) is building a dossier before knowing precisely what evidence will be requested by the HTA Coordination Group \u2013 effectively, preparing an answer to a question that has not yet been asked.<\/p>\n
If outcomes aligned with JCA-defined PICO components (Problem or Population, Intervention, Comparison, Outcome) are not anticipated early, health technology developers (HTDs) can face a last-minute rush to generate evidence within a short submission window. To reduce this risk, HTDs are increasingly turning to artificial intelligence (AI) tools to improve both the speed and quality of PICO planning.<\/p>\n
AI can be useful for rapidly synthesizing information, and is effective at surfacing precedent, but it cannot determine what will be considered decision-relevant in a future JCA. Translating these insights into robust and defensible PICO assumptions requires expert interpretation, informed by a deep understanding of how the reimbursement landscape is evolving. Here, we look at some of the ways it can support PICO planning, as well as its limitations.<\/p>\n
Developing robust PICO assumptions requires input from a variety of sources, including HTA decisions, JCA documentation, and clinical guidelines. However, identifying and generating this information via traditional desk research can be a time-consuming and resource-intensive process.<\/p>\n
AI can help teams quickly identify, retrieve, and summarize large volumes of information, including:<\/p>\n
However, identifying relevant data is only the first step. Filtering and interpreting what that evidence means for PICO planning requires the experience and judgement of seasoned systematic review specialists and HTA experts who help contextualise findings, ensure alignment with reimbursement expectations and validate assumptions. A deep understanding of policy and HTA evidence requirements is important for predicting how decision-makers may prioritize comparators and endpoints within the JCA framework. Together, these perspectives help ensure PICO assumptions are not only grounded in high-quality evidence but are also relevant to how decisions will be made in practice.<\/p>\n
Early PICO planning can also be informed by primary research with appropriate clinicians and payers. Insights from primary research can inform clear recommendations that align with HTA expectations. For example, obtaining clinicians\u2019 perspectives on real-world practice, including evolving standards of care, treatment pathways, unmet need and clinically meaningful outcomes, can provide important context that cannot be derived from published evidence alone. This is important because JCA assessments are expected to focus on outcomes considered clinically meaningful in practice, not simply those captured in existing evidence.<\/p>\n
Ultimately, while AI can streamline evidence gathering and highlight historical precedent, human expertise is needed to interpret these insights, along with inputs from clinicians and payers, and apply them to the current landscape.<\/p>\n
Clarivate\u2019s JCA and HTA Centre of Excellence brings together multidisciplinary teams across HTA, evidence generation and medical writing, with experience spanning more than 250 global HTA submissions and over 500 global value dossiers. This experience includes pan-European joint HTA programs, including successful BeNeLuxA initiative submissions.<\/p>\n
Our consultants work closely with clients from early development through submission to define, stress-test, and refine PICO assumptions. The JCA strategies we present to clients combine evidence review, stakeholder input, and cross-country HTA insight to anticipate likely submission requirements and reduce downstream risk.<\/p>\n
We integrate expertise from clinicians and payers into PICO planning, ensuring assumptions are grounded in real-world practice and aligned with evolving decision drivers. This allows us to identify potential misalignment early and proactively address evidence gaps before they become critical.<\/p>\n
Our systematic review specialists and HTA consultants are supported by proprietary AI tools that help accelerate and enhance evidence synthesis. Importantly, these tools are embedded within expert-led workflows, ensuring outputs are comprehensive, interpretable and defensible. When used together, these capabilities help teams prepare more effectively for JCA, respond more quickly to unexpected PICO requests and identify potential evidence gaps earlier in the process.<\/p>\n