Florence: Trial sites unprepared for coronavirus
Since Chinese authorities first reported the new outbreak of coronavirus in December 2019, businesses worldwide have reeled from the impact. Conference organizers have canceled events, corporations have instructed employees to work remotely instead of traveling to the office, and travel restrictions have thrown plans into chaos. Clinical trials face these same obstacles, with additional complications. With the disease stymieing recruitment and retention, managers are wondering how to proceed.
Ryan Jones (RJ), CEO of Florence Healthcare, told Outsourcing-Pharma (OSP) he believes there is danger in sites being unprepared in the face of the growing coronavirus threat. However, intelligent application of technological solutions, combined with smart planning, may be able to overcome the virus.
OSP: What are some of the components of traditional site management systems that make them vulnerable to crises like coronavirus?
RJ: Visits are the foundation of Sponsor-Site collaboration today: Pre-SIV, SIV, Monitoring, Rescues and Closeout are all centered around a CRA hopping on an airplane and staying in a hotel. If a visit becomes impossible because of a global emergency, the trial effectively stops.
OSP: How is what we’re seeing with the coronavirus crisis different than how past challenges impacted clinical trial firms?
RJ: There are three differences:
- Coronavirus has reached every continent but Antarctica. As a result, it impacts 100% of a sponsor's trial portfolio.
- The travel restrictions for pharma employees US and Europe, where most study management is based, are more expansive than with past outbreaks, limiting staff's ability to visit sites worldwide.
- The research institutions themselves have asked their teams to work from home, creating new demand for remote collaboration at the site level.
OSP: What challenges have you observed sites dealing with as a result of the coronavirus and public/government response?
RJ: We have two customers that have limited study personnel access to their research sites: Fred Hutch and Wellstar. Again, this create a couple barriers to trial progress—the site teams now need a way to work remotely with each other, AND it's impossible for sponsor personnel to get access for site visits.
OSP: How can technology help trial firms avoid or fix such problems?
RJ: Technology can do just about anything today—the hard part is planning for change. Therefore, sponsors that already incorporated remote startup, monitoring, management and closeout in their trial design, and have a vendor toolkit can shift emphasis quickly when needed, will win. Those who haven't started the pivot to remote work will be stuck.
OSP: More specifically, how can solutions like Florence’s eHub and eISF help keep things moving?
RJ: There are two challenges:
- How can site personnel collaborate remotely as a team?
- How will they then collaborate with their sponsors?
Florence makes tools that virtualize the key parts of the clinical trial through a shared workspace—allowing site teams to get work done remotely and then share their output with sponsors.
OSP: How can site managers avoid choosing a quick, possibly inefficient fix over something that’s more beneficial to their operation?
RJ: I'm glad you asked. Online collaboration tools are nothing new, and the temptation is real to move toward Dropbox or something your IT team whipped up. The trouble is, a study's documents are the only things that prove the validity of its results. If you trust your documents and data to a quick fix, you risk invalidating the integrity of both the study and your hard work. Instead, purpose-built clinical research tools have features designed expressly for the research process—saving time and saving your work from crippling compliance mistakes
OSP: Essentially, the coronavirus is just starting to impact the world—how do you think its impact on the industry will evolve in the coming weeks and months?
RJ: I think we'll still see a high level of output. Notably, pharma R&D investment has been robust in the face of crisis. In 2008 when the S&P 500 was down by 39% by the end of the year, R&D spending only contracted 2%. The work will get done, progress will get made, but we will see change in behavior patterns: more online work and less travel.
