Given the global scale of disruption from COVID-19, sponsors are faced with difficult decisions whether to continue ongoing clinical trials.
Due to the pandemic, many clinical trials are undergoing critical protocol modifications and may even put enrollment on hold. Some sponsors are opting to suspend their clinical trials.
The FDA published updated recommendations on May 14 that offers additional guidance for ongoing clinical trials during the COVID-19 crisis. Similar updates were recently published at by the the European Medicines Agency (EMA) in conjunction with working groups from the European Commission and the national Heads of Medicines Agency (HMA). More details is available in our blog .
For ongoing clinical trials, sponsors are executing risk-based contingency plans to protect patient safety and preserve data integrity. Still, there are a number of challenges posed by COVID-19:
- Disruptions may require changes in methods for safety assessments, delivery of investigational products, or locations, such as local labs to take safety bloods or scans.
- There is a good chance that usual research staff, particularly sub-investigators and nurses may not be available to treat research patients. The staff that is available to provide care may not previously have been involved in clinical trials and may require extra support.
- Clinical trial monitoring requires communication at a new level of speed and urgency. Monitors must be kept informed of changes in real-time. And they must in turn have real-time communication with site staff.
Supporting Ongoing Clinical Trial Continuity with Teckro
Teckro connects research staff and monitors with critical study information they need, when they need it – from their own digital device. This includes the protocol and key study documents along with essential guidance on critical study changes.
- From any digital device, answers from the protocol and other study documents are immediately available with Teckro. It also means continuous access to important trial documents and information, even if members of the team are in self-isolation or working remotely.
- Directed communication through Teckro alerts monitors and site staff in real-time to specific study changes relevant to them. Unlike other conventional communication channels being used right now, Teckro is compliant with industry regulations, including FDA 21 CFR Part 11.
- New documents, such as COVID-19 memos can be added instantly to Teckro. And new users can be added on an as-needed-basis for staff who are providing alternative support, such as home healthcare workers.
What we do know is that every regulatory body is guiding that patient safety and data integrity for ongoing trials must be protected in any contingency plans. At Teckro, we help both sponsors and CROs to securely manage trials in this unprecedented global health crisis.
For COVID-19 updates, please visit our dedicated page on COVID-19 clinical trial news.