Demographics in clinical trials have always been scrutinized by the medical community and the public. Are various races, ethnicities, sexes, and ages fairly represented in trials? Does one segment respond better or worse than another to a particular treatment? These questions and more are being answered in the Drug Trials Snapshots section of the FDA website.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
Each snapshot consists of questions and answers about the drug, the demographics of the subjects who took part in the trials, and graphs that help depict the statistics. Drug labels can also be accessed from the snapshot, all in an effort to improve transparency.
What’s wrong with the current degree of transparency in clinical trials? A study conducted by Bioethics International indicated that “only two-thirds of clinical trials per drug that supported new drug approvals in 2012 were disclosed, falling below legal and ethical standards.” This lack of disclosure inhibits the industry’s research and development efforts, and more importantly, hinders the ability to evaluate a drug thoroughly.
In 2016, expect to see more pharmaceutical companies increasing transparency, not only when it comes to trial results, but in every facet of their operations (think Valeant Pharmaceuticals’ relationship with specialty pharmacy Philidor).
To learn about other new trends that we can also expect to see in 2016, fill out the form below or click here.