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{"id":647,"date":"2020-03-16T16:31:02","date_gmt":"2020-03-16T16:31:02","guid":{"rendered":"https:\/\/www.pharmity.com\/?p=647"},"modified":"2020-03-16T16:54:01","modified_gmt":"2020-03-16T16:54:01","slug":"clinical-trials-challenges-in-relation-to-covid-19","status":"publish","type":"post","link":"https:\/\/www.pharmity.com\/staging\/?p=647","title":{"rendered":"Clinical Trials Challenges in relation to COVID-19"},"content":{"rendered":"\n
The COVID-19 dissemination is highly impacting the lives of all of us, personally and professionally and we still do not know how this situation will progress and when we could go back to normality.<\/em><\/span><\/strong><\/h5>\n
Working on clinical research, we need to keep on working to safeguard first the safety and well-being of all those patients currently participating in a clinical trial, and to protect their rights.<\/em><\/span><\/strong><\/h5>\n
The Regulatory Authorities need to be more proactive than never, be flexible and provide right directions in order to protect the patients.<\/em><\/span><\/strong><\/h5>\n\n\n\n
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Sponsor Oversight\u00a0<\/strong><\/span><\/h3>\n
The sponsors oversight activities such as monitoring, or GCP site audits, cannot be stopped but they need to be adapted. The MHRA highlighted in an interesting post<\/a><\/span><\/strong><\/span> published on the 12th March 2016, that alternative oversight mechanisms can be introduced to ensure ongoing subject safety and well-being, providing the following considerations are taken:<\/h5>\n