Initiate’s Post

The #PICO survey will be used for all future Joint Clinical Assessments (#JCAs).   In 2019, the European Network for HTA (#EUnetHTA) published the PICO survey to ensure usability of Joint Clinical Assessments (#JCA) during the national appraisal process. It was concluded that by introducing the PICO survey, the process towards a European PICO for JCA becomes more transparent. Therefore, the PICO survey will be used for all future JCAs. Standardisation versus variance will need to be considered. In various forms, group judgment or #consensus development is used to set standards, make regulatory recommendations and decisions, make payment recommendations and policies, make technology acquisition decisions, formulate practice guidelines, define the state-of-the-art, and other purposes.   The term “consensus development” can refer to particular group processes or techniques that generally are intended to derive best estimates of parameters or general (or unanimous) agreement on a set of findings, targets or recommendations. In #HTA and according to the NIH: · Virtually all HTA efforts involve some form of consensus development at some juncture, including one or more of three main steps of HTA: interpret evidence, integrate evidence, and formulate findings and recommendations. · Consensus development is not used as the sole approach to deriving findings or recommendations, but rather as supported by systematic reviews and other analyses and data. · Consensus development also can be used for ranking, such as to set assessment priorities, and for rating, such as drawing on available evidence and expert opinion to develop practice guidelines.   Rational evidence just isn’t enough for success. In order to demonstrate the value of a product, one must consider contextual factors including patient, economic, organizational, social, and ethical impacts. Demonstrating clinical value (that is usually pre-defined, often by clinical trial programme and subsequent health economic modelling), will not be enough. There is the need to understand the opinions, experience and ambitions of prospective (and holistic) decision makers - patients, prescribers, payers, AND policy makers, to truly substantiate the relevance of an innovation in the real-world.    The application of PICO boards in European HTA will reinforce the need for expert consensus in the process of both developing a health innovation and of subsequently illustrating its real-world (pragmatic) value. Opinion-led scientific research techniques, such as #Delphi and NGT consensus, could then be essential in bridging the gap between innovation and implementation (i.e., the future and the status quo).   If you have any question regarding the method, please contact Triducive®. We’ve been experts in this area for over a decade, helping global #pharmaceutical teams get better decisions, actions. #JCA #EUHTA #PICOproblems #marketaccess References: See comment below.

India emerges as the top choice for conducting global clinical trials, offering a dynamic test bed for healthcare advancements. Highlighting India's healthcare sector as one of the most promising opportunities for such trials, a Harvard scholar shares insights. Dive deeper into this fascinating topic here: https://lnkd.in/gumGt7Bs

While randomized controlled trials (RCTs) have traditionally been considered the gold standard for demonstrating efficacy and safety, it is worth noting that there has been a significant global increase in the inclusion of Real-World Evidence (RWE) in submissions for Health Technology Assessments (HTAs). In this study, which was published today and forms part of my doctoral research, our objectives were as follows: a) To evaluate the current utilization of Real-World Data (RWD) and RWE in the HTA, b) to systematically analyze the barriers, challenges and potential opportunities associated with their inclusion in the HTA process, c) to synthesize the perspectives of several stakeholders across countries regarding the inclusion of RWD and RWE in the HTA process. We hope that these findings can offer valuable guidance to policy-makers and various stakeholders. For those interested, the full-text of the study can be accessed here:

One2Treat, a pioneering start-up in digital health solutions, introduces a groundbreaking approach to clinical research and market access analysis. By incorporating multiple patient-relevant outcomes into a single comprehensive evaluation, One2Treat accelerates the delivery of new treatments to the market while ensuring a more patient-centric approach. Traditional trial designs often overlook crucial aspects of patient well-being, but One2Treat's innovative methodology reduces sample sizes and time to market by including all key outcomes in primary analysis. This revolutionary approach, backed by robust statistical methodology and user-friendly software, aims to align treatments more closely with patient needs, ultimately empowering individuals to access personalized care. To learn more, check out this article on Clinical Research News. 

Check out this insightful blog by the ACRP - Association of Clinical Research Professionals, emphasizing the need to redefine and enhance the clinical trial site selection process. It's surprising to see that information provided by sites during feasibility assessments often isn't captured or stored in databases for future reference by sponsors. This becomes particularly challenging when site staff need to repeatedly fill out paper-based feasibility questionnaires for the same sponsor. Having said that, each study comes with its own unique requirements. One approach to alleviating the site burden could be to capture site feasibility data and organize responses based on the trial's type, phase, and therapeutic area. I'm keen to hear more about the various strategies being implemented to streamline the site feasibility process. https://lnkd.in/gVVBfjpP #siteselection #clinicalresearchprofessionals #sitefeasibility #ethicsandregulatory #medicalaffairs #sitemanagement #clinicaltrialmanagement #studystartup #hospitals #patientrecruitment #database #datacapture

🔬 Exploring the Impact of Real-World Data in Clinical Research At Lifebit, we're committed to advancing clinical research through the integration of real-world data (RWD). Our latest blog post provides a comprehensive look at how RWD is transforming clinical trials, highlighting its role in enhancing research methodologies and outcomes. 📊 Discover the significance of real-world data in clinical research and its potential to shape the future of healthcare. Our insights shed light on the challenges and opportunities presented by RWD, emphasizing its importance in the evolution of clinical trials. 📖 Read our full analysis here: https://lnkd.in/eM5rTUQK #LifeSciences #ClinicalResearch #RealWorldData #Healthcare

Digital Health Products Clinical Evidence OCEBM Evaluation Framework When evaluating digital health products like digital diagnostics, digital therapeutics (DTx), and remote patient monitoring (RPM) solutions, it is essential to use a comprehensive approach that considers the types of clinical evidence, risk profiles, and specific evaluation standards. The Oxford Centre for Evidence-Based Medicine (OCEBM) Levels of Evidence (https://lnkd.in/e5fiVViH) provides a structured hierarchy for evaluating clinical evidence, ranging from the highest quality (Level 1) to the lowest quality (Level 5). This framework helps clinicians and researchers determine the reliability and applicability of evidence across various types of clinical questions and contexts. Level 1: This level includes the highest quality evidence, such as systematic reviews of randomized controlled trials (RCTs) or inception cohort studies. These studies minimize bias and are considered the most reliable sources for clinical decision-making. Level 2: This level includes individual RCTs or well-conducted observational studies. While not as robust as systematic reviews, these studies provide strong evidence when RCTs are not feasible. Level 3: Non-randomized controlled cohort studies or follow-up studies fall under this level. They are more prone to bias but can offer useful insights, particularly in the absence of RCTs. Level 4: This level includes case-series, case-control studies, or historically controlled studies. These are often observational and can help generate hypotheses but are less reliable for establishing causation. Level 5: The lowest level includes mechanism-based reasoning or expert opinion without empirical evidence. This evidence is based on theoretical principles rather than direct research findings. #DigitalHealth #ClinicalTrials #Evidence #digitaldiagnostics #digitaltherapeutics #remotepatientmonitoring #RPM

🔍 Explore how real-world data is transforming clinical research and trials! Our latest blog delves into the impact of real-world evidence on healthcare innovation. Learn about the significance of integrating real-world data and evidence into clinical trial approvals, and how it shapes the future of healthcare. Read now for insights from our experts: https://bit.ly/49S9dCq Want to find out more about Lifebit? Book a demo: https://bit.ly/3TxnfmY #HealthcareInnovation #RealWorldData #Lifebit

Target trial emulation in #HTA #RWD submissions: methodological evolution or industry revolution? Sreeram Ramagopalan ( LCP Health Analytics), Alex Castanon (LCP Health Analytics), Stephen J. Duffield (NICE - National Institute for Health and Care Excellence) and Robert Reynolds (GSK) provide a multistakeholder perspective of #targettrialemulation in the context of RWD submissions for HTA, exploring the expectations set by HTA agencies and providing insights into the implementation challenges encountered by #pharma. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #realworldevidence #realworlddata #marketaccess #healthtechnologyassessment #healthdata

Using RWD as a source of insights to complement clinical trials is not a new concept. But using RWD to understand how clinical care is delivered on the ground and optimise trial protocols in alignment with those realities is a fresh idea trial sponsors may wish to consider adopting. This was the gist of an interview with Alex Deyle, VP and general manager for clinical research at Flatiron Health, at the Society for Clinical Ops Executives U.S. summit last month. In the interview, Mr. Doyle highlighted the value of using contemporaneous RWD to design clinical trial protocols instead of copy/pasting content from past protocols (a common practice). The main benefit of using RWD to inform trial protocol is that it allows sponsors to improve the feasibility of their studies from a site, physician, and patient enrollment and retention perspective. “Real-world data can provide an unbiased view into standard of care today, inform the choice of a comparator regimen based on what’s actually happening at the point of care, and inform inclusion and exclusion criteria to make trials more representative,” Mr. Doyle said. Check out the full interview below for a more nuanced discussion of these considerations and of the challenges that are still holding back the wider use of RWD in the clinical trial setting. Gilles Paubert, Global Head of Cegedim Health Data #realworlddata #rwd #realworldevidence #rwe