FDA plans to streamline regulatory processes for drugs, devices
FDA plans to streamline regulatory processes for drugs, devices FDA announced today that it will soon unveil a comprehensive plan referred to as the Innovative Initiative. The goal of the initiati...
Clinical Trials Transformation Initiative releases guidelines on mobile-derived novel endpoints
The Clinical Trials Transformation Initiative (CTTI), a public-private partnership of pharma companies, academics, and regulators, including FDA, looking to create a new “gold standard” of clinical trial design using digital technology, released new endpoint recommendations today focused on the use of mobile technology in clinical trials.
Medtronic deal with Aetna ties insulin pump payment to patient results
REUTERS: Medtronic Plc said on Monday it signed an agreement with health insurer Aetna Inc under which payment for its insulin pump systems will be tied to how well diabetes patients fare after switching from multiple daily insulin injections. The deal is the latest example of the move toward contracts for prescription drugs and medical devices that attempt to bring down soaring healthcare costs by tying reimbursements to whether the products achieve their intended results. The deal with Aetna will measure health outcomes for patients who transition to one of three Medtronic pumps that self-adjust to keep blood sugar levels in proper range based on patients' individual needs for insulin. "This agreement reinforces our shift towards value-based healthcare," Hooman Hakami, president of the Medtronic diabetes group, said in a statement. "We know technology alone isn't enough and ultimately improved outcomes are what matter." Patients with type 1 diabetes and those with type 2 who have progressed to the n...
Dell Medical School | The University of Texas at Austin
We find ourselves in a turbulent but exciting time in health care. As a society, our capabilities to diagnose and treat disease are accelerating at a remarkable pace, yet unless we understand how to deliver health care in ways that meaningfully and consistently improve patient outcomes, we will fail...
Personalized Consent Flow in Contemporary Data Sharing for Medical Research: A Viewpoint
BioMed Research International is a peer-reviewed, Open Access journal that publishes original research articles as well as review articles in several areas of life sciences. The journal’s Editorial Board is divided into the 55 subject areas included within the journal’s scope.
MyHealthTeams raises $7.3M to give fuller picture of patient experience to pharma sector - MedCity News
Qiming U.S. Healthcare Fund, part of China-based Qiming Venture Partners, led the Series C round. Other investors in the business include Adams Street Partners, CVS Health, The Westly Group, HealthTech Capital and 500 Startups.
Patient Centricity and Convenience? Request a Lyft
The concept of patient centricity continues to evolve, as various stakeholders in the clinical trials industry implement an array of solutions in order to address patients' needs. From a service provider point of view, patient centricity involves bringing more convenience to the patient.
Science 37 Raises $29M To Bring Clinical Trials Directly Into Patients’ Homes - Science 37
Science 37, a trailblazing company focused on “site-less” clinical trials, announced today $29 million in Series C funding led by Glynn Capital Management with participation from GV. The round included new strategic investments from Amgen Ventures, as well as participation from all existing investors Lux Capital, Redmile Group, dRx Capital (a Qualcomm and Novartis joint…
Why Patients in Clinical Trials Are True Medical Heroes
In medicine, we tend to think of doctors as the heroes. But they couldn’t make research breakthroughs without selfless participation of patient volunteers.
Patients with Parkinson's Get Their Say on Device Trial Design
Marie ThibaultWhat might medical device clinical trials of the future look like? It’s a timely question, given the recent New England Journal of Medicine editorial from FDA leaders on the topic.In another sign that device trials are evolving, the first phase of a novel project to adapt clinical trial design to better reflect patient preferences and risk tolerances has been completed. The effort, a collaboration between the Medical Device Innovation Consortium (MDIC), The Michael J.