The Trickett Wendler Right To Try (RTT) Act was introduced in May 2016 by Sen Ron Johnson (R-Wis). According to Johnson, the bill would ensure terminally ill patients, their doctors, and pharmaceutical manufacturers were allowed to administer investigational treatments where no alternative treatment exists. But for all the fanfare around RTT and the slow federal drug approval process, would the RTT legislation actually help patients?
“Rare diseases are bad enough, but the ones that affect children are even more heartbreaking,” says Mike Snape, CEO of AMO Pharma, a virtual biotech focused on rare disease. “The medical need in these areas is greater than ever. They also present challenges for drug developers, especially with clinical trials.”
Clinical news roundup for the week of May 14, 2017 with information on a new head of the FDA, inVentiv Health and INC Research merging, helping patients navigate cancer clinical trials, new standards for trial results, and more.
Benjamin Franklin is often credited with this wise warning: If you fail to plan, you are planning to fail. When it comes to study startup (SSU), and site activation in particular, these words ring true, especially as the clinical trials sector embraces planning as key to boosting study quality. With the availability of workflow-based SSU tools, proactive planning is within reach for stakeholders who view this function as pivotal to improving quality, as measured by audit-readiness and the likelihood of passing regulatory audits.
FDA recently released a snapshot report showing the diversity of clinical trial participants in studies conducted in 2015 and 2016. Out of over 31,000 patients who participated in clinical trials for novel products in 2016, 48% of the study participants were women, which was an increase from 40% in 2015. An increase in clinical trial participation of African Americans was also observed from 2015 to 2016 (i.e., 5% in 2015 vs. 7% in 2016). However, Asian subject participation in clinical studies decreased 1% between 2015 and 2016 (from 12% to 11%, respectively). Overall, the trend towards increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.
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