Summary
Real world evidence can be defined as evidence derived from routinely collected data, that is data not collected for the purpose of research, for example hospital records or administrative claims data. Increasingly, this data is used to facilitate clinical trials. In a series of projects, we evaluate the promises, barriers, and implications of using these emerging resources for clinical research.

Publications

• Current use and costs of electronic health records for clinical trial research: a descriptive study. Mc Cord KA, Ewald H, Ladanie A, Briel M, Speich B, Bucher HC, Hemkens LG; RCD for RCTs initiative and the Making Randomized Trials More Affordable Group. CMAJ Open. 2019 Feb 3;7(1):E23-E32. doi: 10.9778/cmajo.20180096. Print 2019 Jan-Mar.
• Using electronic health records for clinical trials: Where do we stand and where can we go? Mc Cord KA, Hemkens LG. CMAJ. 2019 Feb 4;191(5):E128-E133. doi: 10.1503/cmaj.180841. No abstract available.
• Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data. Kwakkenbos L, Juszczak E, Hemkens LG, Sampson M, Fröbert O, Relton C, Gale C, Zwarenstein M, Langan SM, Moher D, Boutron I, Ravaud P, Campbell MK, Mc Cord KA, van Staa TP, Thabane L, Uher R, Verkooijen HM, Benchimol EI, Erlinge D, Sauvé M, Torgerson D, Thombs BD. Res Integr Peer Rev. 2018 Oct 29;3:9. doi: 10.1186/s41073-018-0053-3. eCollection 2018.
• Routinely collected data for randomized trials: promises, barriers, and implications. Mc Cord KA, Al-Shahi Salman R, Treweek S, Gardner H, Strech D, Whiteley W, Ioannidis JPA, Hemkens LG. Trials. 2018 Jan 11;19(1):29. doi: 10.1186/s13063-017-2394-5. Review.
• How Routinely Collected Data for Randomized Trials Provide Long-term Randomized Real-World Evidence. Hemkens LG. JAMA Netw Open. 2018 Dec 7;1(8):e186014. doi: 10.1001/jamanetworkopen.2018.6014.

Basel research team
Lars Hemkens