And we likely won’t be putting the genie back in the bottle.
When the pandemic hit the U.S. early this year and the first lockdowns began in March, everything shifted. Some studies were postponed; many in-person site visits were halted; telehealth use suddenly skyrocketed; the HHS Secretary issued a Public Health Emergency Declaration; and the FDA issued guidance related to conducting clinical trials during COVID-19. From that point forward, electronic solutions became more relevant than ever before.
When the pandemic first struck, the entire industry needed to pivot so we immediately began surveying our customers. In late March, one of the first things we asked was if the pandemic had impacted their participant attendance and only 20% of the respondents said that it had not. This meant 80% of respondents were experiencing an impact to participant attendance, posing a real threat to clinical trials. But just two weeks later when we asked the same question, the number of people answering that it had not impacted participant attendance almost doubled (39%)—we were moving in the right direction.
In fact, when you look at our survey data from sponsor and pharma companies, the week of April 6th – 14th was when these groups experienced their biggest decreases in patient participation (greater than 25%). From that point forward, the patient participation decrease began to level off and start their climb toward pre-pandemic numbers.
An article in CenterWatch presents a similar optimism. While biopharma sponsors reported a 40% decrease in clinical trial starts for the first part of 2020 because of COVID-19, a second survey showed that 43% of the respondents were optimistic that their clinical trial budgets would increase in the second half of the year.
Change is here to stay
We’ve all had to make adjustments to our protocols in light of social distancing requirements and to keep patient safety paramount. But thankfully, we have the tools to do that. Using these existing tools while also changing our study design have allowed us to keep our trials moving during the pandemic. As a side benefit, we’ll also likely add to the geographical diversity of our patient participants in the future and ideally include previously underrepresented groups.
Regulatory agencies like the FDA are also responding to the change and posted their first guidance document in March with an update in December.
Guidance document (published in March 2020 and updated in December 2020)
These guides map out information about conducting trials and, in certain conditions, encourage the use of eConsent, remote data collection and monitoring, telemedicine, and other tools. Although some companies have been reluctant to change their process, a gentle push from the FDA might be just the thing to encourage them to try something new.
Our Medrio customer survey data further support a move in this direction. More than half of our respondents said they plan to either adopt or increase their use of telemedicine and mobile applications to drive patient outreach and engagement for clinical trials.
Ken Getz, Deputy Director of Tufts University Center for the Study of Drug Development (CSDD), is also encouraged by the pandemic-related changes to clinical trials and sees it as an opportunity for improved processes that will continue long after the pandemic is under control.
In a Center Watch article he stated that, “CSDD found that nearly half — 45% — of companies in 2019 reported that they obtained data using smartphones. Twenty-nine percent said they used mobile health and wearable devices, 21% said they used electronic clinical outcomes assessments, and 20% said they used electronic health and medical records to source data. The use of such methods has skyrocketed during the pandemic, as even sponsors hesitant to use them have been forced to modify their trials to meet global social distancing requirements.”
This is just the beginning. Getz basically sees three takeaways from the clinical industry’s response to the COVID-19 emergency that could propel us forward.
- The industry has shown itself to be remarkably resilient and flexible.
- By necessity, collaboration has increased among researchers and that will likely continue.
- Drug sponsors and regulatory agencies have also shown themselves capable of flexibility in the hopes of finding answers.
It’s a new day, albeit more complex, complicated and hopeful. We are committed to accelerating research by creating patient-focused solutions. Don’t get left behind. Let Medrio help you change your protocols for the better by scheduling an appointment for a demo today.
Guidance document (published in March 2020 and updated in Dec. 2020)