How is artificial intelligence (AI) impacting clinical trials?

There is much talk about clinical trial recruitment and using AI to mine electronic medical records (EHRs). Other applications include protocol design and optimization, and risk-based monitoring;  site selection is primed for disruption with machine learning and AI. (Clinical Leader)

Some cancer clinical trials do not prove superiority

A study published in JAMA Oncology found that 1 in 6 cancer drugs approved between 2013 and 2018 were supported by randomized controlled trials (RCTs) that do not prove the drug’s superiority over the standard of care, as their control arms did not accurately represent the standard of care.  “The choice of control arm should be optimized to ensure that new cancer agents are truly superior to what most clinicians would prescribe outside a clinical trial setting. (docwire)

Drug studies biased by “the funding effect”

The author argues that, in the FDA drug approval process, manufacturers have a strong motivation to promote the effectiveness of their drug, while downplaying the risks. This is called “the funding effect”- when scientists are hired by a firm with a financial interest in the outcome, then the likelihood that the results will be favorable to that firm is dramatically increased. (Bill of Health)

Cell and gene therapies entering clinical trials

Cell and gene therapies are entering the clinical space. There are currently more than 2,900 registered clinical trials in gene therapy, and nearly 1,000 more gene therapy clinical trials currently enrolling human research participants. There are almost 300 ongoing Phase III trials in gene therapy. Genetic engineering is also enabling growth of the pharmaceutical therapy. (BioPharma-reporter.com)

Novartis is cited with Official Action Indicated (OAI)

Novartis was recently inspected and cited with an Official Action Indicated (OAI) as part of their new drug application for their recently approved multiple sclerosis drug Mayzent (siponimod). In one study protocol, blinding was not adequately maintained, and study personnel were given inappropriate access to the database, raising questions as to whether inappropriate access to information led to bias. (Regulatory Focus)

Clinical research professionals not trained for new technologies

In a recent survey, about one-third of clinical research professionals said that the technology systems they use are not intuitive or easy to access, and two-thirds said that automated sharing between systems is not reducing duplicate data entry. Fewer than half agreed that their organization has a training program that sets them up for success.  (ACRP)

WCG creates community forum on research ethics

Do you have a question about research ethics and oversight? You can now turn to a new forum from WCG Clinical, “Ask the IRB Experts”, featuring WCG Clinical’s industry authorities. Questions may be submitted anonymously to the forum, and answers are posted on the WCG Clinical website. To ask a question, go to: https://bit.ly/2XAzDTt

Conducting pediatric oncology clinical trials: a coordinator’s perspective

Tatsiana Verstak interviews Kathy Jackson, CRA at St. Jude Children’s Research Hospital, Memphis, TN.

Kathy Jackson has worked at St. Jude Children’s Research Hospital for 22 years with 15 of those years in clinical research. Her background is in Health Information Management with a Master’s in Information Systems. She has had her Certified Clinical Research Professional (CCRP) certificate since 2006 and her primary research area is leukemia/lymphoma with a focus on pediatric acute myeloid leukemia (AML).

Tatsiana Verstak: Describe your job as a CRA at St. Jude. (Article continues here).

Don't forget! Sunday May 12 is Mother's Day.

Photo by D. Kriegman