EMA Delays Decision on Clinical Trial Data until October
EMA has postponed formal adoption of the policy on publication of clinical trial data until its October 2, 2014 meeting
The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data until its October 2, 2014 meeting.
Further clarifications on the wording and practical arrangements will be discussed by members of the management board, who have confirmed their general support for the overall aims and objectives of the policy, including the more user-friendly amendments proposed by EMA Executive Director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.
The EMA says it welcomes “this additional round of joint reflections and respects all opinions, as well as the views expressed by several Member States, which largely reproduce the complexity of the debate on both political and technical aspects which have emerged during the previous general and more targeted consultation phases.” In the last 12 months, it has attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information.
The agency remains committed to introducing this additional measure towards transparency as soon as possible, so as to enhance public awareness and confidence in the EU authorization system for medicinal products. It also emphasizes that the new policy, if approved, will be without prejudice to the provisions of Regulation (EC) No 1049/2001 on access to documents and the new clinical trial Regulation (EC) No 536/2014, which will become applicable in 2016 at the earliest and will apply to clinical trials conducted in the EU.
Read the full release here.
SOUL Trial Shows Oral Semaglutide Significantly Reduces Cardiovascular Risk in Type 2 Diabetes
April 3rd 2025Phase III SOUL trial shows daily oral semaglutide lowers the risk of major adverse cardiovascular events in patients with type 2 diabetes and atherosclerotic cardiovascular disease or chronic kidney disease, with benefits consistent with injectable semaglutide and other GLP-1 receptor agonists.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
