FDA, EMA Officials: Regulators Must Adapt to Effectively Regulate Precision Medicine

To effectively regulate medicine precision, regulators have to adapt to other testing methods produce, for example officials Food and Drug Administration US (FDA) and the European Medicines Agency (EMA) and the former President of medicines in the UK and Healthcare products Regulatory Agency (MHRA).

The call is made in a commentary published in the journal Nature Reviews: Drug Discovery Friday former president MHRA Alasdair Breckenridge, Third EMA medical officer Hans-Georg Eichler and Jonathan Jarow FDA, which serves as Senior Medical Advisor to the Director of Evaluation Center and drug research.

Specifically, the review authors say regulators should take into account factors through the generation of five key areas to test patient involvement, cost, access and security in order to advance the medical accuracy before risk.

Advances in medicine authors precision have allowed an approach in which genetic heterogeneity in patients and diseases can be used to optimize treatment by determining that patients see the most benefit, or larger risks of a particular treatment.

However, they argue that these advances also present a number of challenges that regulators face in order to facilitate further progress.

challenges

The authors argue that the advent of precision medical threat shake "the basis for regulatory decision making for the past 50 years," the randomized controlled trial (RCT).

In the development of traditional medicine, they say, ACE is considered the gold standard to support regulatory approval. However, precisely in medicine, the authors argue these tests "may not be possible," particularly in cases where a patient population is divided into several, often small, sub-groups.

In light of this, the authors argue that regulators must resort to other forms of evidence, such as adaptive clinical trials or observational studies of the wide range of digital data available through "electronic health records (EHR), patient records and the future of media, it can be social ".

However, the authors state that the use of these alternative methods should not completely replace ECR, "In our opinion, observational studies based on real-world data should complement and not replace ECR, and sometimes that can be the only source of information available, "the authors write.

The authors also argue that regulators should continue supporting a wider patient participation in making regulatory decisions.

"Instead of seeing patients as a large heterogeneous group, medicine precision offers the possibility of working with smaller populations needs of patients, more consistent and better informed to emergencies and potentially only they expressed clearly," write the authors.

For regulators, they say, then keep patient preferences in mind and the reported research results in other therapeutic areas such as oncology, which has traditionally focused on patient clinical outcomes reported.