Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
Health Canada finalizes regulations to provide public access to clinical information on drugs and medical devices – Health Canada
On March 20, 2019, Health Canada will publish final regulations that govern the public release of clinical information on drugs and medical devices. Clinical information will be made available to Canadians via Health Canada’s new Clinical Information Portal.
Read the full news release via Health Canada
HMA offers recommendations on complex clinical trials – Regulatory Focus
The EU’s Heads of Medicines Agencies (HMA) Clinical Trials Facilitation Group (CTFG) issued new recommendations on conducting complex clinical trials. Recommendations focus on how sponsors should clearly describe and justify trial design while also highlighting several data and transparency adaptions. CTFG’s recommendations follow a global trend of how regulatory authorities collaboratively address regulation challenges.
Ana Mulero has the full story here
New Individual Participant Data (IPD) sharing requirements –ClinicalTrials.gov
The International Committee of Medical Journal Editors (ICMJE) now requires a “yes” or “no” response regarding plans to share individual participant data (IPD). A note will now display when the “Plan to Share IPD” data element is “undecided.”
Panel proposes standards for reporting data from immuno-oncology trials – OncLive
In a joint report from the American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (STIC), an expert panel developed 12 recommendations for improving data reporting from immuno-oncology trials. The 12 recommendations are grouped under efficacy data, toxicity information, and details about combination therapies.
Read all 12 recommendations on OncLive