A year of clinical research change, challenge, and champions: Your questions answered

COVID-19 has brought many challenges to clinical research, with investigator sites having to adapt their operations to ensure they successfully meet the safety concerns for both research staff and study participants.

In this on-demand SelectScience webinar, Ellie Robertson, managing director, and Dr. Kirstin Taylor, clinical research physician at Intelligent Clinical, discuss the various issues their new clinical research facility has faced in light of the pandemic, and how increased public awareness of clinical research may influence clinical trial recruitment in the future.

Read on for highlights of the live Q&A session or register to watch the webinar at any time that suits you.

Q: Have you had to gain extra approval for local public health bodies to be able to continue with study visits?

ER: We’ve had quite lengthy discussions with the public health bodies responsible for the areas we recruit from. It wasn't an easy process with our focus and priority being around the national health related research.

We definitely had to provide a strong rationale for the research occurring within the private sector. When they understood the standards that we work to, the discussion became a lot easier.

Q: What kind of feedback have your participants given you when they come in for their visits?

ER: There is no doubt that everyone is wary of the restrictions that they're living under. That was definitely a key element of the feedback from participants that came to us. Just being able to speak in-person with our team and know they were permitted that little element of freedom while taking part was a key talking point. Many said it was the first time they'd been outdoors for weeks and felt great being able to do something positive to help. So, it was all very positive feedback just being able to participate and help in some way.

Q: Did you have to make any major changes to your facility to adhere to COVID restrictions?

ER: Because we were a new facility starting up, we were in the fortunate position of being in the planning and design stage, just as the pandemic really took hold. On that basis, we were able to adjust to consider COVID restrictions as part of the planning. That really set us up well to move forward from restrictions, allowing visits with minimum disruption. We have a second overspill waiting area to allow some movement through the clinic room, while allowing space for people to wait. I think that was quite important to participants as they didn’t have to share a waiting area with anyone else, which gave them a level of comfort.

Q: You asked a poll question about changing the levels of inconvenience compensation to study participants. Do you think this needs to be looked at?

KT: Paying subjects for research participation is always a contentious issue. People are motivated to participate for a variety of reasons. We can't underestimate the worth of the time and travel commitments that participants make when taking part in studies. We need to look at the value of the time and inconvenience for the study participants closely, while at the same time taking into account the ethical considerations of paying participants.

Q: Have you had any negative feedback from participants attending your facility during the pandemic?

KT: Some participants might be more unsure than others when visiting premises during the pandemic. We would always take the time to give clear instructions, answer any questions or concerns that they may have before and during their visit, to ensure that they feel comfortable and safe. We would provide both verbal and written information on all of the safety measures that we have in place. That certainly has paid off, and we've only received positive feedback from participants who have attended so far.

Q: Have you seen an increase in the level of interest in taking part in research locally?

KT: The results of our survey suggested that a lot more people are now interested in taking part in clinical research. We certainly have seen a rise in the level of interest locally. We've had a steady increase in registrations to our database. We have been able to meet all of our recruitment targets and timelines despite all the difficulties that the pandemic has thrown at us.

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