The COVID-19 pandemic has proven a major disruption to the clinical trials industry, forcing the delay of many planned studies and driving drug sponsors and researchers to adapt their study methods so that trials can continue. But many adaptations being used to allow trials to move forward ultimately could yield a more nimble industry that can quickly and effectively respond to clinical trial disruptions. Read More
The COVID-19 pandemic has proven a major disruption to the clinical trials industry, forcing the delay of many planned studies and driving drug sponsors and researchers to adapt their study methods so that trials can continue. But many adaptations being used to allow trials to move forward ultimately could yield a more nimble industry that can quickly and effectively respond to clinical trial disruptions. Read More
The COVID-19 pandemic has had a significant impact on many clinical trials around the world, shining a bright light on the importance of emergency preparedness. Trials must have a disaster or emergency plan in place that’s flexible enough to mitigate the effects of any event that interrupts clinical trial operations — from natural disasters to disease outbreaks to supply-chain disruptions. Read More
Just two years after releasing a major revision of its good clinical practice (GCP) guideline, the International Council on Harmonization (ICH) is planning a new update that would require additional adjustments from sponsors and sites that still may be trying to catch up with the first revision. Surprisingly, the COVID-19 pandemic could end up making that task easier. Read More
While the FDA strictly enforces the handling of investigational drugs, the COVID-19 pandemic is shining a spotlight on the accountability issues involved. Agency regulations are only two paragraphs long, giving investigators and sponsors little guidance on the specifics of the drug management process. In the absence of clear instruction from the FDA and other regulators, the clinical trials industry has begun to develop its own standards. Read More
Continuing clinical trials in the face of the COVID-19 pandemic has posed myriad challenges to an industry some experts have characterized as largely unprepared for a public health emergency. But lessons learned from operating under pandemic conditions may accelerate innovations the industry currently is only toying with, including decentralization of clinical trials and technology-aided remote monitoring. Read More
Continuing clinical trials in the face of the COVID-19 pandemic has posed myriad challenges to an industry some experts have characterized as largely unprepared for a public health emergency. But lessons learned from operating under pandemic conditions may accelerate innovations the industry currently is only toying with, including decentralization of clinical trials and technology-aided remote monitoring. Read More
The impact of COVID-19 on the clinical trials industry will be far-reaching and many of the changes sponsors and sites are making to deal with the coronavirus outbreak will continue to be adopted long after the pandemic is under control. Read More
Examining trial data as it is collected is simply part of good risk management, even though aggregating that data and looking at it quickly can be a challenge.
The expedited approval pathways implemented by the FDA in the past 30 years have shortened many drugs’ road to market, but a new study from Harvard University researchers questions whether the time saved outweighs the risks of approving new drugs without putting them through the traditional clinical trial process.