Many are wondering how to start planning for COVID-19’s impact on clinical trials. Here are some resources that may be helpful:
Regulatory Guidance Documents:
- FDA Updates Guidance with an Appendix Adding Questions and Answers on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- FDA allows expanded use of devices to monitor patients’ vital signs remotely
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- EMA: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
- MHRA: Advice for Management of Clinical trials in relation to Coronavirus
Castor COVID-19 Publications:
- How Castor Supports Research Continuity During COVID-19
- The Impact of ISO 14155 on PMCF Studies Under the MDR
- The Impact of COVID-19 and the Imminent MDR Delay
- Forecasting the Impact of COVID-19 on Medical Device Trials
- Mitigating the Impact of COVID-19 on Clinical Research
- Webinar (On-Demand): Research Continuity During COVID-19
COVID-19 Effects on Clinical Trials:
- CoronaTrials.org
- Clinical Trials in the Time of COVID-19
- Preserving Clinical Trial Integrity During the Coronavirus Pandemic
- Cancer Drug Trials on Hold Amid Coronavirus Disruption
- COVID-19’s Impact on Telehealth & HIPAA Regulations
- COVID-19 Prompts Pfizer to Stop Enrollment in Most Studies
- Lilly Slashes Clinical Trial Activities in Response to COVID-19
- 8 Significant Risks COVID-19 Poses to Clinical Trials – And How to Mitigate Them
About Castor
Based in Amsterdam, The Netherlands and New Jersey, US, Castor is an international health-tech company founded by CEO Derk Arts, MD, PhD to leverage machine readable data to increase clinical trial efficiency. Castor’s Electronic Data Capture (EDC) system enables every researcher worldwide to easily capture and integrate medical research data from any source in real-time, including clinicians, patients, devices, wearables, and EHR systems.
In February 2020, Castor joined the global fight against the Coronavirus by making our research data capture system available for free for all COVID-19 research projects. We have developed ready for use eCRFs based on the WHO standard CRFs, to help researchers start their study or registry in less than an hour. As of April 2, Castor is supporting more than 90 COVID-19 studies across 10 countries. Castor also launched a COVID-19 monitoring and research platform to facilitate the rapid deployment of trials to test Coronavirus vaccines and COVID-19 treatments.
Castor encourages all COVID-19 researchers in need of standardized, high quality data to start their studies by registering here, and to visit their online academy to become familiar with the platform. The WHO-defined CRFs can be downloaded here.
