The COVID-measures have heavily impacted many aspects of clinical research:
- Unavailability of researchers due to other healthcare duties
- Lower enrolment as elective treatments are postponed and patients stay away from the hospital
- Postponement of the start of new trials
- Temporary prohibitions of on-site monitoring
- Follow-up visits could only be performed online or postponed
- Virtual meetings and conferences as the only way to share information and results
- Regulatory agencies heavily burdened with pandemic-related protocols and required amendments due to the changed circumstances
- New rules and regulations for trials have been put in place, varying per country and per phase of the pandemic
We have experienced these issues as well at Diagram, so we are happy that many of our clinical research projects are currently re-starting.
If you recognize one or more of these obstacles and need a solution, start by getting informed!
Information regarding rules and regulations for clinical research in the Netherlands can be found on the website of the CCMO.
An overview of the implications specifically for cardiovascular trials has recently been published in Cardiac Failure Review.
If you need any advice regarding the restart or setup of your project in these circumstances, do not hesitate to contact us.