Fleming TR, Labriola D, Wittes J.
Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity.
JAMA. 2020 May 28;
PubMed.
While the Covid-19 pandemic has affected our research activities, the labs are now returning to their normal operation and the research staff have resumed their experiments. Cell lines and animals have also been well maintained. However, since international flights have been drastically reduced as a result of the pandemic, reagents (such as custom-ordered viruses) and equipment cannot be shipped to Hong Kong on schedule. Research projects have also been significantly delayed as some collaborating universities/institutes and companies are still shut down. We are unable to send out samples or order equipment. Another issue has been the lack of critical on-site technical support, as skilled personnel cannot leave their countries due to travel restrictions and closed borders.
We are already noticing some long-term effects of the pandemic on Alzheimer’s research in Hong Kong. We are conducting AD cohort studies in the hospitals and community. Once the pandemic occurred, there was an immediate drop in the recruitment of both patients and healthy controls. Since it is difficult to anticipate when normal daily activities can resume, the pandemic has impeded the progress of our research and delayed the completion of these studies.
In response to Alzforum’s question about the status of Alzheimer’s research at the University of Pittsburgh, basic research studies are slowly coming back online. I had the first of two walk-through inspections of my basic science lab to ensure we were following guidelines for masks, hand hygiene, distancing, etc. Larger labs will be more challenged by arranging shift-work schedules to accommodate the distancing guidelines, but all these things are surmountable.
It’s a bit different on the clinical side, although things are beginning to move there. too. All non-COVID related clinical studies are still halted unless there is a medical justification to continue, as in the case of a clinical trial that would do the participants harm to stop.
We are all figuring out how best to start up our observational studies and working with our administrations for approval to do so for each individual study. In the interim, many studies have transferred what they can to phone assessments of cognition and related items. Several studies have added components to examine the effect of the COVID-19 lockdown on cognition, mood, and other items of interest. So there are several ways in which we’ve kept in touch with our participants.
Once we get approval to restart, we will have to weigh the risks to our older population that is particularly vulnerable, and respond accordingly. In making plans to adjust—with physical barriers like Plexiglas shields, and extra PPE from masks to face shields to gowns in appropriate contexts—we find that many items are on back order, and so slow the process.
The great unknown is what will happen when we do finally decide it is appropriate to start up? What will our participants think and do? How will they answer the question, “Why would I want to continue (or start) in-person participation in this study?” We can be certain that the risk/benefit equation that people consider has changed to some degree by a perception of increased risk, no matter how careful we are. I think we need to be prepared for some degree of decreased participation. How large will that decrease be?
I have been inspired many times by the dedication of our research participants. Perhaps I’ll be inspired again to see how willing they are to continue, or start participation, in AD-related clinical studies.
We have halted visits but kept in contact with the centenarians. From our cohort, three centenarians contracted COVID-19; one centenarian was already in a bad condition and he passed, but the other two survived.
This is in line with the many reports of centenarians surviving COVID-19, including 107-, 111-, and even 113-year-olds. It seems as though the immune system of these centenarians is still in very good shape.
We have performed a survey about how centenarians and their family members feel about us coming by to perform study visits. There are different responses, but this week, we will indeed include a new 106-year-old participant who lives independently and who feels comfortable about a visit. She will be the first person we will include in our study cohort since the COVID-19 outbreak. It goes without saying that we will take all precautions necessary to prevent a potential infection.
Many others are very uneasy about letting "strangers" into their homes. This will severely complicate visits, and it will also take away some of the joy of the study visits. So we’re taking it step by step, and communicate closely with the centenarians about what people feel comfortable with, given the constraints imposed by COVID-19.
Meanwhile we’ve adopted the idea to “never waste a good crisis.” We are currently implementing the use of tablets during study visits, which will simplify the entry of data in our database, and improve data quality. Also, we’ve updated some of the paperwork that still needed to be resolved. We’ve continued to perform many analyses that were still on our plate.
On the whole, I am extremely relieved that COVID-19 has not severely affected the centenarians in our population.
We will have to see how we can continue including new centenarians, but very slowly and carefully we will ramp things up again.
Comments
Hong Kong University of Science & Technology
While the Covid-19 pandemic has affected our research activities, the labs are now returning to their normal operation and the research staff have resumed their experiments. Cell lines and animals have also been well maintained. However, since international flights have been drastically reduced as a result of the pandemic, reagents (such as custom-ordered viruses) and equipment cannot be shipped to Hong Kong on schedule. Research projects have also been significantly delayed as some collaborating universities/institutes and companies are still shut down. We are unable to send out samples or order equipment. Another issue has been the lack of critical on-site technical support, as skilled personnel cannot leave their countries due to travel restrictions and closed borders.
We are already noticing some long-term effects of the pandemic on Alzheimer’s research in Hong Kong. We are conducting AD cohort studies in the hospitals and community. Once the pandemic occurred, there was an immediate drop in the recruitment of both patients and healthy controls. Since it is difficult to anticipate when normal daily activities can resume, the pandemic has impeded the progress of our research and delayed the completion of these studies.
View all comments by Nancy IpUniversity of Pittsburgh
In response to Alzforum’s question about the status of Alzheimer’s research at the University of Pittsburgh, basic research studies are slowly coming back online. I had the first of two walk-through inspections of my basic science lab to ensure we were following guidelines for masks, hand hygiene, distancing, etc. Larger labs will be more challenged by arranging shift-work schedules to accommodate the distancing guidelines, but all these things are surmountable.
It’s a bit different on the clinical side, although things are beginning to move there. too. All non-COVID related clinical studies are still halted unless there is a medical justification to continue, as in the case of a clinical trial that would do the participants harm to stop.
We are all figuring out how best to start up our observational studies and working with our administrations for approval to do so for each individual study. In the interim, many studies have transferred what they can to phone assessments of cognition and related items. Several studies have added components to examine the effect of the COVID-19 lockdown on cognition, mood, and other items of interest. So there are several ways in which we’ve kept in touch with our participants.
Once we get approval to restart, we will have to weigh the risks to our older population that is particularly vulnerable, and respond accordingly. In making plans to adjust—with physical barriers like Plexiglas shields, and extra PPE from masks to face shields to gowns in appropriate contexts—we find that many items are on back order, and so slow the process.
The great unknown is what will happen when we do finally decide it is appropriate to start up? What will our participants think and do? How will they answer the question, “Why would I want to continue (or start) in-person participation in this study?” We can be certain that the risk/benefit equation that people consider has changed to some degree by a perception of increased risk, no matter how careful we are. I think we need to be prepared for some degree of decreased participation. How large will that decrease be?
I have been inspired many times by the dedication of our research participants. Perhaps I’ll be inspired again to see how willing they are to continue, or start participation, in AD-related clinical studies.
View all comments by William KlunkAmsterdam University Medical Center
We have halted visits but kept in contact with the centenarians. From our cohort, three centenarians contracted COVID-19; one centenarian was already in a bad condition and he passed, but the other two survived.
This is in line with the many reports of centenarians surviving COVID-19, including 107-, 111-, and even 113-year-olds. It seems as though the immune system of these centenarians is still in very good shape.
We have performed a survey about how centenarians and their family members feel about us coming by to perform study visits. There are different responses, but this week, we will indeed include a new 106-year-old participant who lives independently and who feels comfortable about a visit. She will be the first person we will include in our study cohort since the COVID-19 outbreak. It goes without saying that we will take all precautions necessary to prevent a potential infection.
Many others are very uneasy about letting "strangers" into their homes. This will severely complicate visits, and it will also take away some of the joy of the study visits. So we’re taking it step by step, and communicate closely with the centenarians about what people feel comfortable with, given the constraints imposed by COVID-19.
Meanwhile we’ve adopted the idea to “never waste a good crisis.” We are currently implementing the use of tablets during study visits, which will simplify the entry of data in our database, and improve data quality. Also, we’ve updated some of the paperwork that still needed to be resolved. We’ve continued to perform many analyses that were still on our plate.
On the whole, I am extremely relieved that COVID-19 has not severely affected the centenarians in our population.
We will have to see how we can continue including new centenarians, but very slowly and carefully we will ramp things up again.
View all comments by Henne HolstegeMake a Comment
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