Cybersecurity in the clinical research world is “a little bit special,” one expert says, because sites must deal with confidentiality, data privacy and integrity, as well as the breach notification process imposed by regulators. And never has the threat to trial data been so high. Read More
The impact of COVID-19 will continue well into 2021, and sites and sponsors already are looking at how new methods, new collaborations and lessons learned during the pandemic can be applied in the years ahead to reduce trial costs and timelines, increase participation and strengthen electronic solutions to make trials more effective and efficient. Read More
In the past, drug trials have taken months or years to conduct with reams of data to analyze before a sponsor could go to a regulator for product approval. But under the emergency conditions caused by the pandemic, vaccine approvals will be based on early data analysis and much smaller data sets. Read More
During the COVID-19 pandemic, it’s taken an average of 7.5 months for pharma and biopharma organizations to implement a decentralized trial from protocol redesign to first patient televisit, according to a new survey from PPD. Read More
A new survey shows one in five cancer patients are far less likely to participate in future clinical trials due to fear of COVID-19 exposure, raising the question of whether enrollment levels that have dropped precipitously since the beginning of the pandemic are likely to recover after the virus is controlled. Read More
While research done at academic sites often brings greater confidence in results, they are often slow, underenrolled and “clunky,” says Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), currently also head of the therapeutics arm of Operation Warp Speed. Read More
As part of its ongoing efforts to make clinical trials more representative of the population, the FDA last week issued a final guidance on what sponsors should do to make trials more accessible and appealing to under-represented racial, ethnic, gender and age groups. Read More
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