Strict regulations and international guidelines have always been present in the clinical trials sector as bringing pharmaceuticals and devices to market is a highly regulated industry in order to protect patient safety.
There are several regulations and guidelines taking shape over the next year that will significantly influence how Sponsors carry out their clinical trials. The ICH GCP E6(R2) addendum, for example, is the most significant change to happen in over 20 years.
CROS NT is outlining some of the major regulations affecting clinical trials under FDA and EMA authority. In all these cases there seems to be two main objectives: (1) Increased patient safety; and (2) a more risk-based approach to clinical trials to ensure complete oversight of data.
In the infographic below, CROS NT outlines some of the major changes:
CROS NT recommends discussing these regulations and guidelines with your service provider. The ICH GCP E6(R2) addendum places oversight responsibility with the Sponsor, and therefore clinical trial Sponsors should be sure they have a proper process in place with their CRO to ensure trusted oversight. As more Sponsors turn to risk-based monitoring they need to have a better understand of the data coming from sites. Clinical analytics solutions and data visualization, along with the right biometrics resources, can help Sponsors take control of their data.
For Sponsors conducting trials in the European Union and preparing for market launch in the EU, they need to be aware of Clinical Trial Regulation 536/2014 and the General Data Protection Regulation (GDPR). Europe is taking steps to protect patient identity and data, but at the same time make data transparent for the benefits of clinical research. Drugs and devices submitted for market approval, regardless of the outcome, will need to publish the data in an EU portal without identifying patients. Sponsors will need to work with CROs to anonymize this data.
CROS NT related services:
CROScheck clinical analytics solution
Data De-identification and Anonymization
Solutions to comply with GDPR
Centralized Biometrics for Small to Mid-Sized Companies
Data-Driven Monitoring and a Risk-Based Approach