This is your one stop shop for updates on CTTI projects, developments in the clinical trials enterprise and other relevant news. To read the full-length entry, or to share a specific blog post, click on the title of the article of interest.
The EU Commission published their proposal for a regulation on clinical trials on medicinal products for human use. This is the revision to the EU clinical trials directive. To read the proposal, click here .
The new legislation proposed by the Commission will make it easier to conduct multinational clinical trials, i.e. trials conducted in more than one Member State.
The proposed Regulation introduces the following changes in particular: A simplified authorisation procedure1 allowing for a fast and thorough assessment of the application by all Member States concerned and...
Brad Hirsch, MD, MBA, and Steven Cheng, PhD, presented posters at the American Society of Clinical Oncology meeting. The posters reflect work done about the state of clinical trials using data from ClinicalTrials.gov.
Analyzing kidney cancer trials, Hirsch's poster, Improving the impact of clinical research: A systematic analysis of kidney cancer trials , concluded that the ClinicalTrials.gov database provides the opportunity to understand the landscape of clinical trials in oncology. The study also found that by studying and analyzing the database, strengths and weaknesses in...
Hirsch and team presented a poster titled "The State of the Oncology Clinical Trials Portfolio: Insights from ClinicalTrials.gov."
Conclusions from this study include:
Bray Patrick-Lake has been named as Director of Stakeholder Engagement for the Clinical Trials Transformation Initiative (CTTI). She will support efforts to actively engage patient advocacy organizations and other stakeholders in the achievement of CTTI's mission. As a patient advocate herself, Ms. Patrick-Lake will serve as a liaison to the patient advocacy community, implementing strategies to leverage the patient perspective to inform CTTI priorities and initiatives. In addition, Ms. Patrick-Lake will facilitate communication with all stakeholders to enhance awareness of CTTI's work and...
On Monday, March 26th, Sumeet Subherwal, MD, MBA presented "Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs-An Evaluation of the ClinicalTrials.gov Database" at the American College of Cardiology's 61st Annual Scientific Session and Expo. Click here to view the poster.