If you look at recent news headlines, it’s very evident the COVID-19 pandemic is making its mark on the R&D space. Consider the pharmaceutical manufacturers that have either halted enrollment or halted some planned studies that were set to start, and you’ll see some significant disruption in the clinical trials space. But the story is not necessarily as grim as that might showcase. While we certainly have seen a slowdown, and as we look across the portfolio of R&D, we certainly have seen some of that slowdown in screening and enrollment, but we also have seen continuation of trials. In fact, some of the trends we’re seeing along those lines are encouraging.
One of the big trends that we’ve begun to see has actually been a breath of fresh air from the regulators. In the United States in particular, the Food and Drug Administration (FDA) has come out with several iterations of new guidelines around the conduct of clinical trials. In my 20-30 years in the clinical trials industry, this has been the quickest that the FDA, as well as the European Medicines Agency (EMA) to some degree, have released a somewhat renewed and revolutionary version of guidelines around the monitoring of clinical trials.
Strengthening remote monitoring
The shift has been specifically in allowing for more aggressive remote monitoring techniques. The way that we monitor clinical trials is to send clinical research associates out to monitor the trials at the investigational site. Those associates are the individuals who make sure the wheels don’t come off the bus. That is, they ensure that we’re compliant on three critical measures mandated by the FDA. Each time they go into the field, these individuals prioritize the safety of participants, ensure the maintenance of good clinical practices, and minimize risk to trial integrity and the integrity of the trial data. They’ve really opened up the possibilities for remote monitoring.
The regulators have also looked at new technologies, and while that has been mentioned in some of the previous guidance documents, in particular with risk-based monitoring, it’s always remained somewhat grey, and left that up to various sponsors and CROs to manage that adoption at their own choosing. So, the regulators have, and really by necessity during the COVID-19 pandemic, come along to push the envelope there.
It’s been very important for CROs, sponsors, and the Association of Clinical Research Organizations (ACRO) to help with really shepherding and consulting and advising the regulators to push the envelope in that regard. That’s been a welcome change. I believe that change will continue to carry on as we move into recovery because most trials will have to be “COVID-resistant” moving forward. This necessity is arising because as we recover, what we’re seeing, particularly in China and in South Korea, is patients are still reluctant to come back to clinics, and that will persist for a period of time.
Teaming with regulatory authorities
As we look at the current regulatory landscape, what’s really important in the regulations across the board, both inside and outside the U.S. and in Asia, as well as in EMEA, is that we need to keep our local Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs), and our national health authorities up to speed on what’s happening, changing needs, and the informed consent, and having mechanisms to do that remotely.
It’s very important to be capable of consulting our regulatory authorities on necessary changes, particularly if we have to conduct site visits and patient care visits in the home in non-traditional manners, as well as to allow centralized and remote monitoring visits to occur, and to have procedures in place for that.
So, if you already have an infrastructure in place that allows for those practices, all the better because you can leverage that. If you don’t, those procedures must be established.
Maintaining best practices
Finally, it’s essential to minimize the risk to trial and data integrity, and to make sure that steady contact continues, particularly in this phase. Additionally, make sure that you’re performing early analyses and predictive analyses of the safety and efficacy impact of anything that is happening, such as missed visits and dropouts, and then also look at alternative procedures for data collection so that you can collect as much data as possible during this period.
With the disruption of COVID-19 in the clinical trial space, we have partnered with regulatory authorities to maintain patient safety, verify good clinical practice and data integrity. This has necessitated a broader adoption of remote monitoring and virtual patient visits to achieve clinical trial continuity for the vast majority of trials.