Interest in making greater use of real-world data (RWD) is growing among clinical researchers, regulators and healthcare providers alike, but effective collection and analysis of RWD on a large scale will require a collaborative “ecosystem” in which data collection is standardized for easier analysis. Read More
The European Medicines Agency’s (EMA) latest revision to its guidance on trials affected by COVID-19 cautions sponsors against using unblinded data when assessing the risk of incomplete trial results and recommends they use an independent data monitoring committee for analysis if data must be unblinded. Read More
A photograph of a signed informed consent form of a patient in isolation is an acceptable proof of consent, according to the FDA’s latest update to its guidance on conducting clinical trials during the COVID-19 crisis. Read More
Attendees at the recent MAGI Clinical Research Cloud Conference heard advice from a variety of industry experts on running clinical trials now and into the “new normal.” The following is a selection of speakers’ thoughts on subjects from patient recruitment to negotiating clinical trial agreements (CTA).Read More
A majority of European clinical trials of COVID-19 drugs are being run by universities and companies who either lack experience or have a poor track record in uploading their results to the EU’s trial database, which could lead to wasted research, according to a new report. Read More
As the race to develop an effective COVID-19 vaccine by year’s end gains momentum, the FDA said it plans to issue a guidance on developing and licensing them. Read More
More than half of the top 50 pharma sponsors have had to make protocol changes in their ongoing trials since the COVID-19 pandemic began, driving up volume at IRBs and sparking “remarkable growth” in clinical trials over the past three months. Read More
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