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Hi

Please check the following link. I believe it will help you.

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments

Regards

@ Sazal Miah:

This discussion is not about COVID-19 trials but about research studies affected by the disease. As an example: you have an ongoing single-center clinical study aiming at recruiting a certain number of patients but your facility is locked down due to COVID-19 infections. Can you set the study on hold an start recruiting again after reopening? How will this affect you study protocol and scientific rigor?

BS

On-going research studies particularly human subject studies are indeed affected by the current pandemic situation. Taking into consideration of patient/subject safety as well as the safety of staffs/study administrator involved, it is best for a temporary “pause” especially in terms of recruitment. In view of hospital based research (which is my current working environment) involving patient recruitment, there is an overall downfall in number of patients visiting a hospital either for consultation, follow up or even elective procedure. Hence, it directly reflects to a lower or even no recruitment which definitely isn't a good thing as all research studies that do have a target number to hit and timeline to chase after. With the agreement of all parties involved, a temporary hold could be proposed to the Ethics Committee subject to the EC approval. This action not only is beneficial in terms of safety but also preserves the quality of study without the need to compromise in terms of reduced numbers or visits. However, existing subjects could proceed with the standard of care/scheduled followups remotely via phone or other means of communication and data sharing. Details that could not be completed via phone (eg. Blood parameters and ECG) could be reported as missing data leading to a minor protocol deviation. Necessary amendments in study protocol could be made and also indicated in future publications as measures of crisis management.

Dear Thavin,

thank you for this valuable contribution.

Safety for all participants is definitely an important aspect and pausing of ongoing studies may indeed be an option. I also agree that changes made to study protocols need to be documented and reported (say on respective portals for registered clinical trials and in publications). I would also recommend to indicate (in publications) if the study protocol had been affected by the situation and which steps had been taken.

Among others, one question remains to be answered in the clinical setting you describe. If the characteristics of patients is changed due to the current situation (and thus recruitment bias occurs if the study is not paused), which measures apply to detect the "back to normal" situation?

BS

here are some interesting thoughts on different aspect:

https://science.sciencemag.org/content/368/6492/693

including this comment:

"Trials focused on mental health could face other complications...[and]...may in fact have entirely different cohorts pre- and postpandemic.”

An early article already addressd different aspects

"Coronavirus disruptions reverberate through research"

https://science.sciencemag.org/content/367/6484/1289?_ga=2.103038985.804910601.1589881338-1437382882.1589881338

including the following statement "But the costs to research will be substantial ... Institutions facing local outbreaks have made tough decisions about which research to prioritize, often favoring projects addressing coronavirus while cutting back others."

I would like to address your question:"... overall study protocols may have been flawed". 1- In the OH Chloroquine protocols, the inclusion criteria and the selection process are very important. Indeed the drug may no longer act at the inflammation stage, when it becomes a self-sustained process where the virus is no longer or less involved. I have not yet seen randomised double blind proactive studies selecting patients at the onset of the symptoms and covid19 diagnosed within 48hours, then randomised placebo vs OH Chloroquine.

2- As a former medical director of multinational Pharma Co and retired drug evaluator at the Canadian government, we may not disregard the huge lobbying and financial trouble that an old and inexpensive drug may generate. In particular the cardiac side effects have to be better described, in their stats, variety and according to patient profile, in such a way as to compare them with the existing well documented pharmacovigilance of the drug.

@ Marie-Madeleine Bernard: This discussion is not about COVID-19 trials but about research studies affected by the disease.

I understand it is about research studies affected by Covid-19, which includes how COVID-19 trials themselves may have been affected by the conditions (professional and political) of the on-going pandemic.

Dear Marie-Madeleine Bernard, I appreciate your contribution, also with respect to mentioning the importance of monitoring side effects. I also agree that political interest has already affect research on COVID-19, some of these forcing premature data presentation/interpretation with strong effects on the final results.