Maxis Clinical Sciences’ Post

Highlighting the Future of Regulatory Decision-Making with Real-World Evidence (RWE) Exciting developments in the use of Real-World Evidence (RWE) to support EU regulatory decision-making are here! A recent review by the European Medicines Agency (EMA) explores the impact of RWE from a pilot study conducted between September 2021 and February 2023. Key Takeaways: 🔹 61 research topics identified: Focusing on medicine safety, clinical trial design, drug utilization, clinical management, and disease epidemiology. 🔹 27 regulatory-led RWD studies conducted: Emphasizing incidence and prevalence rates of clinical outcomes, including adverse events. 🔹 Need for robust data: Highlighting the importance of accessing fit-for-purpose, representative data and timely evidence to meet regulatory timelines. The study underscores the importance of RWE in filling evidence gaps and guiding future regulatory decisions, especially for pediatrics and rare diseases. 🌐 The question remains: How to ensure that not only relevant data is available, but also, that its quality is good and actionable to help regulators and the industry? https://lnkd.in/dQu4JVKH #HealthEconomics #MarketAccess #RealWorldEvidence #RegulatoryAffairs #Pharma #HealthcareInnovation #EMAPilotStudy

International Society for Pharmacoepidemiology (ISPE) Call for Manuscripts, submission deadline Oct 1 ISPE annually funds proposals for manuscripts that could be used for guideline development, or reference documents for pharmacoepidemiology, including pharmacovigilance, drug utilization research, outcomes research, comparative effectiveness research, and therapeutic risk management. Suggested topics of interest to the Society include (see instructions for more): · Methodological topics/considerations in the area of COVID-19 vaccines and therapeutics safety ‎and effectiveness · Real-world evidence · Precision medicine · Patient-generated health data · Signal detection in emerging large data sets such as EHR or social media · Use of pharmacological / mechanistic data in pharmacoepidemiologic studies · AI and machine learning approaches vs classical PE to examine causal hypotheses · New methods in pharmacoepidemiology · Best practices related to specific approaches in pharmacoepidemiology · Evaluation of risk minimization approaches · Measuring impact of pharmacovigilance activities · Guidance/methods (design/analysis) of multi-database studies · Any topic contributing to ISPE's strategic mission   Proposal are assessed against the following criteria: · Appropriateness of issue to the general ISPE membership · General interest of topic to ISPE membership · Feasibility to accomplish the stated objectives · Importance (or significance) of proposal to the field of pharmacoepidemiology · Visibility (the extent to which the proposed manuscript will be used and, if so, raise the visibility of pharmacoepidemiology) · Collaboration among multiple organizations, work sectors, and geographic regions, and · Consistency with ISPE strategic goals, objectives and priorities   Proposals must conform to the format described in this document (https://lnkd.in/dGsQaeHH).   Submissions for 2023, which may only be submitted online, are now being accepted at this website (https://lnkd.in/dCaMhFMK) with a deadline of 11:59 PM US Eastern Time on Sunday, October 1. The deadline will not be extended, and proposals submitted via other means will not be accepted.   General Timeline Oct 1 – submission deadline Oct 31 – Joint Manuscript Proposal Review Subcommittee completes first review, provides feedback Nov 30 – author responses to feedback due Dec 20 – final selections made; notifications to lead contacts #pharmacoepidemiology #manuscripts #pharmepi #ISPE

Real-World Evidence (RWE) in pharmacoepidemiology refers to clinical findings on the usage, benefits, and risks of a medication derived from analyzing Real-World Data (RWD) collected in everyday clinical settings. The clinical significance and real-life impact of a medication can often be better understood through RWD and RWE, as controlled trials may not fully capture all applications of a drug in practice. The European Medicine Agency (EMA) has invited all European stakeholders to share their perspectives on the technical and operational aspects of the ICH M4 draft guidelines by August 30, 2024. https://lnkd.in/eUT7gm47 #FDA #RWE #RWD #EMA #EuropeanUnion #DrugDevelopment #Pharmacoepidemiology #DigitalHealth #RegulatoryAffairs #MedicalWriting #BioPharma #ClinicalTrial

We'll be attending #ICPE2023 in Halifax. Why? Because our software platform for systematic review and evidence synthesis is quickly becoming an integral player in pharmacoepidemiology and pharmacovigilance. Harness the power of AI to dramatically speed up a variety of functions: Benefit-Risk Assessment: SLRs provide a holistic picture of existing knowledge about drug benefits & risks, ensuring our insights are based on the entirety of existing evidence. Post-Marketing Surveillance: By synthesizing data from multiple studies, SLRs offer a broader view of a drug's safety once it's out in the market. This is crucial in detecting rare side effects or long-term impacts. Determinants of Adverse Drug Reactions: SLRs help identify consistent patterns across studies, offering clarity on what factors might lead to adverse reactions. Comparative Effectiveness Research: Want to know which treatment works best? SLRs collate data from various studies, ensuring the most effective treatments are highlighted. Transforming RWD into RWE: Defining populations and harmonizing real world datasets often requires looking for established historical patterns in published literature. Patterns of Drug Prescribing and Dispensing: By summarizing existing research, SLRs reveal trends in how drugs are prescribed and dispensed. Drug Utilization Studies: Understanding drug usage patterns becomes more precise with SLRs. Are you going too? Reserve a time to meet with President Keith Kallmes and Director of Implementation and Client Success Ranita Tarchand. Click here to schedule: https://lnkd.in/gkTNggSj Hope to see you there! #pharmacovigilance #pharmacoepidemiology #AI #RWE #RWD #systematicreview #metaanalysis

Pharmacoepidemiology and Safety Sciences can be defined as the application of epidemiologic reasoning, methods, and knowledge to the study of the uses and effects of drugs in human populations. Pharmacoepidemiology is one of the oldest and largest areas of research and training in POP. It can be defined as the application of epidemiologic reasons, methods and knowledge to the study of uses and effects of drugs in human populations. As such pharmacoepidemiology is the last but critical stage in the evaluation cycle of drug effects and can provide detailed information on whether, in what type of patient and under what conditions drugs are safe and effective in real-world populations. Please consider this video where our faculty and students introduce the science of pharmacoepidemiology. Examples of pharmacoepidemiologic research include: Drug safety studies Comparative effectiveness studies Studies of real-world effects of drug-drug and drug-disease interactions Drug utilization studies including study of determinants of inappropriate medication use

Check out this excellent paper with a clear roadmap for the key considerations for inferential studies using RWD!😄

Valuable roadmap for anyone considering inferential studies using RWD. Another positive step towards standardising reporting and in doing so facilitating the determination of study quality by HTAs, regulators and reviewers.

Quantify Research is excited to see you next week at the 39th annual International Society for Pharmacoepidemiology (ICPE) meeting in Halifax! Our CEO Kirk Geale will be there in person to discuss all things related to Nordic data and RWE, drug safety, utilisation, comparative effectiveness, health economics, and more. Get in touch to book a meeting! Quantify Research [email protected] #ICPE23 #Pharmacoepidemiology #Pharmacovigilance

Utrecht University has appointed Helga Gardarsdottir as Professor of Real World Data for Decision Making on Medicines. Gardarsdottir and her team investigate how so called “real world data”, including healthcare data from routine practice, can be used more effectively to gain insights into the safety and effectiveness of medicines, in order to enable well-informed clinical and regulatory decisions. The use of real world data for informing clinical and regulatory decisions is currently receiving significant attention. Gardarsdottir: “While many stakeholders are eager to make more use of this type of data, there are also critics of its usage. Evidence generated with real world data is not going to replace that from clinical trials. It should be seen and used in a complementary manner.” Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University Read more on her research: https://lnkd.in/eHhEr7TQ #UUScience #ClinicalPharmacology #Pharmacoepidemiology