Features

Training Trends in Clinical Trials: Filling the Gaps

April 22, 2019

NASHVILLE — Attendees at last week’s ACRP 2019 conference discussed and debated a number of diverse clinical research topics, but the buzz about improving clinical monitor and coordinator training came through loud and clear in several sessions.

Data-Sharing Not a Pipedream, But Still a Challenge, Experts Say

April 15, 2019

Collaboration, integration and data-sharing are popular concepts in a life sciences industry focused on finding novel treatments to meet critical healthcare needs. But are clinical trials really ready to “walk the walk” when it comes to making their data accessible to other sponsors and researchers? Not just yet, say industry experts.

Intentional or Accidental, Bad Data Can Kill Trials and Careers

April 1, 2019

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.

Too Many Amendments, Too Little Planning, Expert Says

March 25, 2019

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.

Clinical Trials Are About Hope and Possibilities, Author and Trial Veteran Says

March 25, 2019

In 2011, Mary Elizabeth Williams was diagnosed with metastatic melanoma, a finding that usually means a patient has six to seven months to live. Knowing melanoma doesn’t respond well to traditional cancer treatments, she decided to take a chance on a phase I immunotherapy trial of a new drug. Williams wrote about her experience in her book, A Series of Catastrophes and Miracles: A True Story of Love, Science and Cancer. It was a journey, she says, from last resort to hope and possibilities.