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Home » Authors » Gienna Shaw

Gienna Shaw

Articles

ARTICLES

System Hacked

Hackers Target Clinical Trials, Threatening Trial Enrollment and Data Security

November 3, 2020
Gienna Shaw
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

Security Breaches Getting Harder to Spot, Expert Says

May 20, 2019
Gienna Shaw

Relationships, Not Money, Key to Avoiding Conflict of Interest

May 13, 2019
Gienna Shaw
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

EU’s Privacy Rule Impacts Sites, Sponsors Globally

April 8, 2019
Gienna Shaw
The European Union’s new data privacy rules have consequences for clinical research around the world and sorting out how and when they apply is no simple task. Read More

Intentional or Accidental, Bad Data Can Kill Trials and Careers

April 1, 2019
Gienna Shaw
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

Too Many Amendments, Too Little Planning, Expert Says

March 25, 2019
Gienna Shaw

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.

Read More

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