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    Home > Medical News > Medical World News > EMA officials discuss: how can real world evidence be turned into credible evidence?

    EMA officials discuss: how can real world evidence be turned into credible evidence?

    • Last Update: 2019-11-27
    • Source: Internet
    • Author: User
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    The key to gaining trust is to start with a frank "interrogation" mentality Instead of just trying the new way of bottled old wine, let the new way pass the fair, transparent and forward-looking verification Real world evidence (RWE) may provide an opportunity to learn more about the benefits and risks of drugs How to turn such an opportunity into reality? Recently, several officials from the European Drug Administration (EMA) published articles in the journal Clinical Pharmacology and therapeutics sponsored by the American Society of clinical pharmacology and therapeutics to discuss how to turn RWE into credible evidence With the development of EMR ecosystem, the amount of data is increasing Addressing data quality issues, including data loss, and differences in terminology and data formats will be more challenging Industry and regulators have recognized the need for quality assurance and comparison procedures, and have taken a series of measures to improve the quality of real world data (RWD) to a level acceptable to regulators Collaboration among stakeholders, as well as opportunities for data processing and quality improvement, are growing In spite of the intermittent progress, it can be expected that the industry will eventually achieve the goal of making medical data from different sources available to researchers for secondary analysis in quality and quantity The auxiliary use of RWD is gradually improving in such aspects as medication, disease epidemiology or safety assessment If fully applied, RWD can be used in efficacy demonstration, hierarchical treatment and other fields to provide information for regulatory, reimbursement and individualized treatment decision-making The new data source will help to solve other problems that are currently being explored However, even high-quality data can't be transformed into trustworthy evidence without sufficient statistical methods In order to solve this bottleneck problem, in the past decade, the industry has proposed or improved a series of relatively novel methods to analyze RWD or combine RWD with randomized clinical trial (RCT) data Supporters believe that these methods can eliminate possible bias and provide reliable evidence However, many people believe that the acceptance of non RCT methods will lead to a decrease in the quality of evidence because non RCT methods tend to produce a large number of undetected results or biases The author believes that RCT method will still be the best available standard, which is necessary in many cases, but it needs to be supplemented by other methods to solve the problem that traditional RCT method is not feasible or there are ethical disputes Deliberately avoiding the use of novel and reliable methods will have the same harmful consequences In drug regulation, "methodology aversion" refers to the reluctance of regulators (and other decision makers) to adopt new statistical methods or other data analysis methods Among all stakeholders in the pharmaceutical ecosystem, different degrees of "method aversion" are not uncommon Part of the reason for the reluctance to adopt a new approach may be due to concerns, conservatism, or a lack of in-depth understanding of the new approach From the perspective of researchers, if we only focus on novel research design and analysis and lack of inspection and verification of relevant methods, it will lead to a lack of understanding of truly useful methods by external stakeholders, which may make the toolbox become a "black box" and fall into a "black box trap" Photo source: content team of Wuxi apptec Patient data from real world data (RWD) and completed RCT trials are being used in secondary analysis on an unprecedented scale; the industry has adopted a series of new methods and research designs The author of the paper said that the proper way is to get rid of overheating and calm down In order to ensure that regulators can accept the new analytical method, it needs to be tested and verified These tests and validation methods are almost the same as the way to evaluate new drugs: they are carried out in a forward-looking, controlled and predetermined way ▲ examples of (New) methodologies used to analyze different types of data (content team mapping by Wuxi apptec) Recognizing the rapid development of innovation and the important role of regulators in catalyzing and empowering regulatory science and innovation, EMA released its regulatory science development strategy in December last year It aims to promote evidence generation through collaboration, improve the scientific quality of evaluation, "provide better evidence for regulatory agencies and health technology assessment (HTA) / payers, support regulatory assessment and decision-making", and "patient-centered drug access" Relevant measures proposed in the strategy include the promotion of clinical trial innovation (focusing on new trial design, statistical concepts, endpoints and data collection methods), and the development of methods for integrating clinical care data sources into regulatory decisions Source: reference [4] EMA has been supporting the qualification of innovative development methods for specific applications in the field of drug research and development through scientific advice procedures Through the interaction between regulators and innovators, determine the research and activities required for the new method to meet its intended use Through collaboration with health technology assessment institutions, payers, patient rights organizations and stakeholders, ensure that all relevant information can be scientifically reviewed and discussed in detail under sufficient and transparent conditions The author of this paper draws attention to the potential obstacles to the practical application of new data sources Researchers should not only focus on novel research design and analysis, but also test and verify relevant methods to avoid falling into the "black box trap" In order to overcome the "method aversion", the developers of new methods should solve the problem of "data aversion" prospectively, and use open access RCT and RWD to test the new methods The author believes that the key to gaining credibility is to start from a frank but "interrogative" attitude, not only try the new way of bottled old wine, but let the new way pass the fair, transparent and forward-looking verification In addition, it is necessary to reach a plan on "firewall" in advance to ensure that the evaluation of the method will neither endanger the product nor remedy it "If the developer wants the reviewer to accept the new method, he must use some of the tested drugs in the methodology development to try every detail." [1] Hans-Georg Eichler, Franz Koenig, Peter Arlett, et al Are novel, non-randomised analytic methods fit for decision-making? The need for prospective, controlled and transparent validation Clinical Pharmacology & Therapeutics Oct 1, 2019 Retrieved Oct 4, 2019 from https://doi.org/10.1002/cpt.1638 [2] Chapter 19 of the doctrine of the mean: "erudite, inquisitive, thoughtful, discerning and practicing." [3] Bauer, P., König, F The risks of methodology aversion in drug regulation Nat Rev Drug Discov May, 2014; 13(5):317-8 doi: 10.1038/nrd4319 [4] EMA EMA Regulatory Science to 2025 Dec, 2018 Retrieved Oct 5, 2019 from https:// [5] Zachary Brennan When Can RWE Translate into Credible Evidence? EMA Officials Discuss Oct 3, 2019 Retrieved Oct 5, 2019 from https://endpts.com/when-can-rwe-translate-into-credible-evidence-ema-officials-discuss/ A kind of
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