by Syneos Health_1 | 21 Aug, 2019 | EMA, Real Word Evidence, Real World Research Design, Regulatory Grade RWE
Source: Cave, A. , Kurz, X. and Arlett, P. (2019), Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe. Clin. Pharmacol. Ther., 106: 36-39. doi:10.1002/cpt.1426 Real-world data (RWD) offers the possibility to derive novel...
by Syneos Health_1 | 30 May, 2019 | CHCUK News & Articles, Consultation, Real Word Evidence, Real World Research Design, Regulatory Grade RWE
May 2019 – the Center for Drug Evaluation (China) has released a draft document for public review on “Key Considerations in Using Real-World Evidence to Support Drug Development” Background and Purpose Randomized Controlled Trials (RCTs) are...
by Syneos Health_1 | 8 May, 2019 | Cures Act, Real Word Evidence, Real World Research Design, Regulatory Grade RWE, White Paper
In contrast to clinical development, in which the randomized controlled trial (RCT) is the go-to study design, real-world research encompasses a broader array of designs from which to choose. There are retrospective approaches, including database analysis and manual...
