FEDERAL CURES ACT CALLS FOR ADVANCES IN CLINICAL TRIAL MANAGEMENT

In December 2016, Former President Obama signed the 21st Century Cures Act. Two years in the making, this landmark, bipartisan bill seeks to drive advancement of the American healthcare system. Costing $6.3 billion dollars, the Cures Act will:

  • Accelerate the approval of new drugs and medical devices
  • Reinvest in Vice President Biden’s Cancer Moonshot, aimed at expediting cancer research and discoveries
  • Provide funding for President Obama’s BRAIN initiative, focused on improving treatment for neurological diseases like Alzheimer’s
  • Generate funding for the President’s Precision Medicine Initiative to customize treatments and identify cures
  • Deliver support and funding for mental health policies designed to better deal with serious mental illness, suicide and related concerns
  • Allocate $500 million a year to help individual states provide resources and treatment for rampant opioid addiction

The substantial funding for this initiative demonstrates government commitment to precision medicine and drives development in research, translational medicine and biomedical research. A Federal investment of this size will facilitate the progression of clinical trials, genetic and oncology research and enable data sharing to direct better patient outcomes. To accomplish this, strategic partnerships between academic centers, hospitals, universities, institutes, consortium, and private sector businesses need to be developed.

Specifically, proper collection and storage of patient data, coupled with secure mechanisms to readily share sensitive information, will be fundamental to the success of the Cures Act, and will require advancements in technology, informatics, analytics and data management to meet these goals.

Sampleminded has created a sophisticated LIS methodology, allowing for seamless integration into workflows in a manner that joins patient information to samples and test results, while providing real-time chain of custody information. This enables organizations access to annotated data, advancing their research efforts.

In addition, as The Cure Act paves the way for faster treatment approvals, the US will see a heavier focus on post-market studies designed to establish more stringent efficacy metrics. Sampleminded’s software dedicated to facilitating the execution of clinical trials (CLINOPS) is uniquely suited to manage these processes, and its experience and track record will prove increasingly critical as advances are made.

The Cures Act provides funding for many Sampleminded users who are furthering health care through clinical trials and translational research. This includes divisions of the NIH who are working on all areas of cancer and precision medicine research.

With Sampleminded providing the operational software, researchers can focus on enhancing healthcare and improving patient outcome.