Video Consent Proving an Obstacle in India Trials
In November 2013, India's Drug Controller General required that all clinical trials must record on video a participant's informed consent.
In November 2013, India's Drug Controller General required that all clinical trials must record on video a participant's informed consent, which according to a recent article, is driving recruitment rates down.
Physician investigators report the reasons patients are declining clinical trials because of the video recorded consent. Those reasons include, they believe the videos could be leaked; tampered with or misused. Also, social and religious reasons, as well as poor self image during a sickness. The physicians in the article report ranges between 10%-40% of patients declining to participate in the clinical trial after learning of the video consent requirement.
While some believe the video consent has a noble intent, the questions behind the ethics of not allowing participants the decision to opt-out of the video requirement, as well as the long-term effects on science are being debated.
Read the full story here.
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.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
