December 27, 2017 | It’s been a big year for the clinical trials and the healthcare industry. Developments in real world data, privacy regulations, and sensor data have led to a fantastic year of groundbreaking announcements and thoughtful discussions. As we head into 2018, we at Clinical Informatics News would like to take a moment and reflect on the achievements from this past year. In that spirit, here are the top 10 stories of 2017, ranked in order of popularity.

--The Editors

1. Using Real World Data to Enhance Clinical Trials

Randomized clinical trials remain the trusted standard for assessing pharmaceutical drug and medical device safety and efficacy. Real world data can provide important health information about patients in the social context of their day-to-day lives. Read more

2. Baskets and Umbrellas: Trial Design for Precision Oncology

An article published online on JAMA Oncology’s Patient Page proposes two types of clinical trial for testing precision medicine treatments of oncology. Read more

3. The Intelligent Trial: AI Comes To Clinical Trials

Artificial intelligence is revolutionizing health care and advancing the clinical trial process faster than any Hollywood AI robot could predict. Read more

4. Wearables Shaping The Future Of Clinical Trials

The demand for wearables and sensors in clinical trials is on the rise. By leveraging remote medical devices, there is an opportunity to collect novel endpoints and supplemental data that may improve the regulatory case, make the case for reimbursement more compelling, open up participation to a wider population and/or reduce site visits for patients who may not live close to an investigative site. Read more

5. Building the Pool of Alzheimer’s Trial Volunteers

An effort is underway to identify and collect healthy adults with various APOE gene statuses to potentially match them with available Alzheimer’s disease research studies. The GeneMatch program aims to create a pool of willing Alzheimer’s trial participants already characterized with APOE gene status. Read more

6. The Rise of Real-World Evidence

Real-world data sources and analytic technologies seek to answer what treatments work for whom, why, in what context, and at what cost. And everyone wants in. Read more

7. Johnson & Johnson Invests More Data In YODA Project

Johnson & Johnson has shared pharmaceutical and medical device data through the Yale University Open Data Access (YODA) Project, promoting scientific discovery and data transparency along the way. Read more

8. The Remote Clinical Trial Concept In Clinical Research – Definition And Opportunities

The pharmaceutical industry has generally remained behind the curve when implementing digital health technologies and interacting with patients within the context of clinical trials. Remote trials provide an interesting spin on the use of digital health components to enhance the patient experience. Read more

9. What Europe’s New Privacy Regulations Means For US Trials

In less than eight months, The European Union’s General Data Protection Regulation goes into effect. The GDPR applies to all types of data, but it will have a special impact on clinical trials, even ones run by US companies. Read more

10. New GCP R2 Guideline Emphasizes Risk Management Through People, Process, And Technology

A major update to the international guideline for clinical trials, from the International Conference on Harmonisation, emphasizes quality risk management, critical processes, and data identification. Read more