Clinical trials post-COVID: Why remote studies may persist after pandemic - Aussie researcher

Dr Mike Armour, senior research fellow who specialises in reproductive health at NICM Health Research Institute, said the above when presenting at the 2021 Annual Conference organised by industry association Complementary Medicines Australia (CMA).

He was speaking on the topic “Complementary medicine research in the time of COVID: Lessons from NICM’s Clinical Trials Team.”

The institute has shifted a number of its human clinical trials in the past 1.5 years due to hospital visit restriction and social distancing policies brought by COVID-19.

With both researchers and study participants getting accustomed to this mode of research, he said that the institute has been planning to improve remote clinical trials next year. 

“People would like to continue with the remote process even post COVID-19. It is much more convenient for them and anyone who has run clinical trials knows that participant recruitment is the most frustrating aspect. It is the most uncertain stage and the one that keeps us up at night. ​

“And so, anything that we can do to streamline and encourage engagements with participants [remotely] is really important.​

“Our next step is looking at a completely remote and semi-automated consent process,” ​he said.

In the past, seeking consent from the study participants had to be conducted in-person.

“That [seeking consent in-person] was often quite complex, especially if you were recruiting people for a dementia trial; trying to get them to sign a consent form and send it back was already very difficult,”​ he explained.

Remote consent ​

The pandemic had since forced the researchers to adopt new modes of working.

In April last year, the institute was told to halt all face-to-face clinical trial research immediately by the WSU Human Ethics committee (HREC), until they came up with contingency plans on managing the risks associated with clinical trials.

To which, the institute explored the idea of seeking consent from participants in remote.

“Instead of normally what we will do, which is speaking to someone over the phone, or in person, running them through the consent form, getting them to sign the form, scanning that and saving them in Dropbox or One Drive, keeping the paper form in a filing cabinet, we now didn’t have to do any of that. ​

“The remote consent means that we are able to get people on the phone, and we are able to run through the things that we will normally do. ​

“Once they have understood what they have consented to and once they have the chance to read the participant information sheet, we then send them a link to their email and a text message which opens up a unique and secured online form, which allows them to again read the participant information sheet, read the consent form and sign it digitally,” ​he explained.  ​

The information is then stored securely online, where any changes made would be locked.

“Not only is this helpful to us as researchers, it is incredibly helpful for anyone who doesn’t necessarily want to travel especially during COVID-19 or can’t travel,” ​he said of the remote consent process.

Semi-automated remote consent ​

For next year, the institute will continue the remote consent process, while including the element of semi-automation – where the researchers would not even need to call the participants, but could send videos to explain the concept and process of the trial. 

“We will ask the participants to click a link which takes them through the participant information sheet, we then have videos of researchers like myself explaining the process, followed by an interactive quiz, where they have to be able to answer all the questions. ​

“We might ask things like how long the trial is and how does randomisation work. If they managed to pass this, we then give them the option to enter their details and book a call with one of the research teams if they have any questions which is unclear.​

“If they have passed everything and are happy, they can do an e-signature on the consent form.”​

Remote package management ​

A remote package management was also adopted to send out test materials and relevant instructions to the study participants.

To ensure that the correct items were received, the participants would receive a weblink on their phone, which would prompt them to switch on their phone cameras to take photos of the package.

The photos would then be directly uploaded and stored on the online platform, which in turn would help with the internal audit process.

“[During the audit process,] we can see the photo evidence that they have received the right package which matches with the randomisation code and that its intact and undamaged,”​ Dr Armour said.

Limitations ​

At the same time, Dr Armour also acknowledged that not all clinical trials could be conducted remotely.

For instance, NICM’s trials on using acupuncture for polycystic ovary syndrome (PCOS) and vascular dementia had to stop, since the former requires both the researchers and participants to come into close proximity, while the latter requires hospital visits. 

Due to COVID-19, conducting blood test is also considered a high-risk activity and is suspended.