Sponsors are overwhelming sites with a growing volume of safety reports, and sites are fighting back. The magnitude of the problem of unnecessary and overly burdensome safety reporting is getting worse; in the past three years, some sponsors of oncology drugs have unleashed a five-fold increase in safety reports. Read More
More than 60 percent of current drug submissions to the FDA include real-world data (RWD) in some form, and agency officials are saying the FDA needs to expedite honing its skill set in regulating the use of it in trials. Read More
Because of how difficult it is to find participants for rare neurodegenerative disease trials, the FDA says in a recent draft guidance that phase 1 trials of gene therapies (GT) for such diseases may be sufficient to produce evidence for regulatory submissions. Read More
Regulatory officials from the U.S., UK, EU and Japan said their agencies should harmonize rules for clinical trials targeting rare diseases because patient populations in some study areas number only in the hundreds worldwide. If enacted, such a strategy could lead to faster development of advanced therapy medicinal products used to treat ultra-rare diseases. Read More
Despite all the hoopla about patient engagement, the fact is that the industry is still not really engaged. Recent surveys show more than 80 percent of industry respondents never seek patient input as part of protocol development and almost one-third estimated they sought such input less than 25 percent of the time. Read More
A new study finds that trials sponsored by the pharma industry fared better during the pandemic and were more likely to complete enrollment compared to trials sponsored by academia, hospitals and medical centers. Read More
Researchers said they were able to more than double, on average, the pool of eligible patients in oncology clinical trials by using artificial intelligence (AI) to broaden restrictive eligibility criteria. Read More
