Compliance In Focus

In the fiscal year of 2017, the Food and Drug Administration (FDA) performed over 900 inspections through the Bioresearch Monitoring (BIMO) Program. Of those 900 inspections, approximately 70% of the inspections targeted clinical sites. Without a doubt, there is some prediction about when and where the FDA will announce inspections during the course of clinical trial, both from the sponsor and the clinical sites.

On May 25, 2018 the General Data Protection Regulation (GDPR) goes into effect in the European Union (EU). This regulation has a broad scope beyond companies performing clinical research – all personal data falls under this jurisdiction which includes web search engines, social media, and much more. But specifically, how does this new regulation affect personal data collected during a clinical trial and what do Sponsors and Contract Research Organizations (CROs) need to do to ensure compliance? Here we aim to address the highlights of the GDPR and its implications on clinical research.

On August 31, 2017 The Food and Drug Administration (FDA) issued the finalized guidance manual for medical device companies’ use of real-world evidence (RWE) and real-world data (RWD) to gain FDA approval for their medical devices. The FDA draft guidance was originally issued on July 27, 2016 to the public to give those in the medical device industry an opportunity to provide comments prior to finalization. Additionally, the FDA hosted a webinar on the topic to provide additional guidance on October 10, 2017. Per the FDA, the guidance was issued “to clarify how we evaluate RWD to determine whether it may be sufficiently relevant and reliable to generate the types of RWE that can be used in FDA regulatory decision-making for medical devices.” This includes whether or not FDA will require an Investigational Device Exemption (IDE) to determine the safety and effectiveness of a device.

The Food and Drug Administration (FDA) released an updated Guidance for FDA Staff for Sponsors, Contract Research Organizations (CROs) and Monitors on April 19, 2017 as part of the Bioresearch Monitoring (BIMO) program. The updated version contains revisions to Part III, section D, which provides additional instructions to FDA investigators related to www.ClinicalTrials.gov reporting and registration requirements that came into effect on January 18, 2017 in 42 CFR Part 11.

Obtaining useful and meaningful data is one of the goals of any clinical trial. However, in order to attain the necessary data, subject participation in clinical trials is paramount as subjects are the heart and soul of a clinical trial. One of the keys to a successful clinical trial, no matter the stage or trial type, whether it is a drug or device study, is meeting subject enrollment requirements. Understanding how the general public views clinical trials and how clinical research professionals might shape that opinion, is vital.