It is critical that partners in clinical research develop systems to maximize the potential of big data while protecting the confidentiality of patient information, to further biomedical research, continued the statement, according to a statement from the European Federation of Pharmaceutical Industries and Associations.
It is critical that partners in clinical research develop systems to maximize the potential of big data while protecting the confidentiality of patient information, to further biomedical research, continued the statement, according to a statement from the European Federation of Pharmaceutical Industries and Associations (EFPIA).
“There is still work to be done. Clinical trials represent on average 58.6% of the total development costs of a new medicine. Across Europe we need to continue to shape the regulatory and clinical landscape putting patient safety at the center and reducing the administrative requirements, speeding up the conduct of clinical trials, while reducing costs. We have to attract patients to participate in trials, provide them with meaningful, jargon-free information and transparent lay summaries of trial results,” stated EFPIA.
To devise meaningful lay summaries, EFPIA is organizing -- together with EFGCP, EPF and EATG, EGAN and Harvard MRCT -- a workshop in Brussels on May 29th, with the aim of embarking on a discussion that will help develop a vision and framework that address stakeholder needs, while increasing transparency and value for public health.
“Looking to the future, clinical trial data will be enhanced by the availability of real world data from patient registries, hospitals and general practitioners. Data will be generated more continuously than ever and have the potential to revolutionize general practice and clinical development. To be able to do so, systems need to adapt for real-time assessment and action,” noted EFPIA.
World Clinical Trials Day, held on May 20th, provided an ideal opportunity to recognize the contribution of the many thousands of trial participants, researchers, companies, sponsors, journals, registries and regulators that have contributed to advances in modern medicine, according to the statement.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.