https://orcid.org/0000-0001-7401-6142
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Abstract
Treatment of neuropathic pain (NP) is challenging. Interest in real-world evidence (RWE) for benefit-risk assessments of NP treatments increases given the paucity of drugs showing efficacy in randomized controlled trials and restricted labels of available medicines. To provide further context, a literature review regarding regulatory use of RWE and a clinical trial registry search for randomized controlled trials over the last 10 years was carried out. Taken together, and especially for available NP treatments, there is increasing support to consider RWE when evaluating their benefit-risk profile. Examples are provided in which RWE could be used effectively for updating the product label and informing treatment recommendations. Collected and analyzed according to state-of-the-art standards, RWE can inform treatment recommendations and product label decisions.
Plain language summary
Neuropathic pain (NP) is caused by damage to the sensory part of the nervous system and is often described as burning, throbbing or shooting pain. This condition is difficult to treat and may become chronic. Before a new treatment can be approved for use, its effectiveness and safety must be shown in controlled clinical trials. Such trials are difficult to conduct in NP and often fail. Therefore, there is increasing support for the use of real-world data (routinely collected data from e.g., patient registries, electronic medical records, health insurance claims databases) to evaluate the benefits and risks of treatments. This article presents the views of three pain specialists about the value of real-word evidence in general and specifically for the evaluation of pharmacological treatments of NP.
Supplementary data
To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2022-0057
Author contributions
All authors critically revised for important intellectual content, approved the final manuscript version and agreed to the submission.
Financial&competing interest disclosures
R Baron declares grant/research support from EU projects ‘Europain’ (115007), DOLORisk (633491) and IMI Paincare (777500), from German Federal Ministry of Education and Research (BMBF): Verbundprojekt: Frühdetektion von Schmerzchronifizierung (NoChro) (13GW0338C), the German Research Network on Neuropathic Pain (01EM0903) and from Pfizer Pharma GmbH, Genzyme GmbH, Grünenthal GmbH, Mundipharma Research GmbH und Co. KG., Novartis Pharma GmbH, Alnylam Pharmaceuticals Inc., Zambon GmbH, and Sanofi-Aventis Deutschland GmbH. He reports speaker fees from Pfizer Pharma GmbH, Genzyme GmbH, Grünenthal GmbH, Mundipharma, Sanofi Pasteur, Medtronic Inc. Neuromodulation, Eisai Co. Ltd., Lilly GmbH, Boehringer Ingelheim Pharma GmbH&Co. KG, Astellas Pharma GmbH, Desitin Arzneimittel GmbH, Teva GmbH, Bayer-Schering, MSD GmbH, Seqirus Australia Pty. Ltd, Novartis Pharma GmbH, TAD Pharma GmbH, Grünenthal SA Portugal, Sanofi-Aventis Deutschland GmbH, Agentur Brigitte Süss, Grünenthal Pharma AG Schweiz, Grünenthal B.V. Niederlande, Evapharma, Takeda Pharmaceuticals International AG Schweiz, Ology Medical Education Netherlands, Ever Pharma GmbH, Amicus Therapeutics GmbH, Novo Nordisk Pharma GmbH, Nanobiotix SA France and Stada Mena DWC LLC Dubai. He declares consultancy work for: Pfizer Pharma GmbH, Genzyme GmbH, Grünenthal GmbH, Mundipharma Research GmbH und Co. KG, Allergan, Sanofi Pasteur, Medtronic, Eisai, Lilly GmbH, Boehringer Ingelheim Pharma GmbH&Co. KG, Astellas Pharma GmbH, Novartis Pharma GmbH, Bristol-Myers Squibb, Biogenidec, AstraZeneca GmbH, Merck, Abbvie, Daiichi Sankyo, Glenmark Pharmaceuticals S.A., Seqirus Australia Pty. Ltd., Teva Pharmaceuticals Europe Niederlande, Teva GmbH, Genentech, Mundipharma International Ltd. UK, Astellas Pharma Ltd. UK, Galapagos NV, Kyowa Kirin GmbH, Vertex Pharmaceuticals Inc., Biotest AG, Celgene GmbH, Desitin Arzneimittel GmbH, Regeneron Pharmaceuticals Inc. USA, Theranexus DSV CEA Frankreich, Abbott Products Operations AG Schweiz, Bayer AG, Grünenthal Pharma AG Schweiz, Mundipharma Research Ltd. UK, Akcea Therapeutics Germany GmbH, Asahi Kasei Pharma Corporation, AbbVie Deutschland GmbH&Co. KG, Air Liquide Sante International Frankreich, Alnylam Germany GmbH, Lateral Pharma Pty Ltd., Hexal AG, Angelini, Janssen, SIMR Biotech Pty Ltd. Australien, Confo Therapeutics N. V. Belgium, Merz Pharmaceuticals GmbH, Neumentum Inc., F. Hoffmann-La Roche Ltd. Switzerland and AlgoTherapeutix SAS France. In the past 3 years, G Mick has received honorarium for scientific expertise from Boiron, Grünenthal, Lilly, Novartis and UPSA. MG Serpell has received honoraria from Astellas, Grünenthal, NAPP and Pfizer for speaking at meetings. His institution has received research support in the past 5 years from HTA and CSO sponsored studies and commercial sponsored studies (Pfizer, Grünenthal, Lateral Pharma Pty Ltd.) The initial virtual meeting was organized and chaired by Grünenthal GmbH, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The sponsor paid for writing and editorial assistance (provided by Elke Grosselindemann and Birgit Brett) and for journal fees associated with the publication of this article. Grünenthal was given the opportunity to review and comment on the manuscript; however, the authors take full responsibility for the content.