Emerging pharmaceutical companies are those that have five or fewer study starts in a calendar year. According to an analysis by WCG, the number of emerging pharma study starts has been increasing and the trend has continued into 2020. Historically, the industry has targeted common, broader conditions, but many smaller pharmaceutical companies have developed more focused pipelines. As a result, there has been a dramatic shift to therapeutics for rare diseases. But what has happened to this trend in the COVID era?
Over the past 2-3 months, a record number of studies have been placed on hold, and all industry players have had to modify operations and create contingency plans. Micael Cioffi of WCG compared the number of study holds between emerging pharma companies and mid-to-large sized companies, and found a significant difference between them. Since COVID began, emerging pharma companies have actually started more trials and only 43% of studies were placed on hold, while 57% of mid-large pharma trials were paused.
Manny Lazaro, Vice President of Jounce Therapeutics, offered insight on how their company has been managing the COVID crisis. Jounce Therapeutics develops immunotherapies for cancer and created a four phase plan, which is still being carried out:
1. Acute Response Phase
Jounce Therapeutics elected to keep enrollment open, but knew they would have to remain flexible and continue to adapt to each research site’s situation. By tracking the impact on critical areas of trial operations (e.g., participant safety, enrollment numbers, availability of central vs. specialty labs, IP, internal resources) and implementing routine calls with clinical research coordinators, they developed mitigation strategies.
2. Adaptive Implementation Phase
Mitigation strategies (e.g., remote monitoring) were implemented and were modified to fit the evolving situation. “Steps that were put into place last week may not be applicable for the current or following week,” said Lazaro. To allow site staff to focus attention on more pressing matters, they deprioritized other tasks such as query resolution.
As the industry prepares to ramp-up trial activities again, their company plans to double up on clinical research associates to support site staff and will continue to monitor critical areas of trial operations.
4. Planning for the Post-COVID Future
The pandemic will likely increase the use of telemedicine and other innovative solutions such as eConsent, but Lazaro says, “We are still far away from the widespread adoption of remote technology.” Moving forward, he advises that clinical research sites and sponsors strongly consider increasing the use of these technologies as they can lessen participant and site burden. As for protocol design, future protocols will likely be more flexible and should include provisions for unanticipated events such as COVID. Lazaro also suggests that emerging pharma companies develop clinical trial continuity plans in addition to business continuity plans.
Omer Siddiqui, Vice President of Development Operations at Alector, explained that his company adjusted study protocols to include a hybrid approach, meaning a combination of virtual visits and on-site visits, to continue ongoing studies throughout the pandemic. Alector is an emerging biopharma company that develops therapies for neurodegenerative conditions. “For some studies and conditions, it is not possible to eliminate on site visits,” said Siddiqui.
Whether now or post-COVID, Siddiqui agrees that clinical trial companies need to reduce site and patient burden and adopt hybrid approaches. While the industry may not be able to go fully virtual, sites and sponsors should continue to leverage technology (e.g., eSource, eRegulatory, clinical trial management systems, remote monitoring) wherever possible.
In closing remarks, Lazaro offered the following advice to clinical research sites: “Sites should be bold, open and candid in what they need or what sponsors can do better. We want to treat this as a partnership… so give us the feedback.”
- Michael Cioffi, Senior Vice President of Clinical Solutions and Strategic Partnerships at WCG
- Manny Lazaro, Vice President and Head of Clinical Operations and Data Management at Jounce Therapeutics, Inc
- Omer Siddiqui, Vice President and Head of Development Operations at Alector