There’s one area that’s increasingly vulnerable to cyberattacks and alluring to bad actors: trials data. It’s not only a goldmine of personal health information (PHI), but also rich with competitive and proprietary information that’s ripe for industrial espionage. That vulnerability might also be leading to lower enrollment as potential trial participants become more wary of sharing their data. Read More
BOSTON — Although there are plenty of horror stories about bad actors who manipulate investigations for their own financial gain, conflicts of interest can also be subtle and even unintentional. Read More
Two kinds of data integrity problems cast shade on research results and erode trust in scientific inquiry: questionable research practices and flat-out misconduct, a data integrity expert says. And while intentional misdeeds can result in regulatory, or even criminal, action, both categories can cause irreparable damage to clinical trials, companies and individuals. Read More
The rise in the number of protocol amendments occurring before the first patient has even received the first dose is a reflection of failure in planning trial design, says Ken Getz, director of sponsored research programs at the Tufts Center for the Study of Drug Development.
Amending a protocol often means adding endpoints, distinct procedures and patient visits that may not be strictly necessary, Getz said in a webinar last week. “You don’t have to gather data or report on every finding,” he said.