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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.