Overnight, the spread of COVID-19 has disrupted seemingly every industry from airlines and restaurants, to manufacturing. As the clinical research industry races towards a cure, it too faces distinct challenges. With rapid changes in regulations, patient safety concerns, and other COVID-19 related pressures, how can companies stay resilient and even thrive in these unprecedented times?
Digitizing the clinical trial management process is one way companies can adapt. Specifically, this article will discuss how contract research organizations (“CROs”) can utilize these solutions to navigate the COVID-19 crisis.
DISRUPTIONS TO CLINICAL TRIALS IN A TIME OF COVID-19
There are currently over 300,000 studies registered around the world. In the span of a few weeks, COVID-19 has impacted every aspect of the clinical research space, from increasing patient hesitancy, lack of funding, investor concerns, to regulatory change. The pace of the industry has changed practically overnight and continues to evolve.
Recently, biotech giant Amgen announced that it would be evaluating the impact of COVID-19 on a trial-by-trial basis while dropping enrollment for those sites where there is uncertainty about the ability to maintain patient safety and data integrity.
The delay and suspension of studies are not unique to Amgen. Eli Lilly, Galapagos, Myers Squibb, ObsEva, and Prevention Bio, have all paused or delayed trials, new site activations, and enrollments.
These disruptions have an immediate and profound impact on CROs. Here are some ways that they are using technology to minimize disruptions in their business.
HOW CLINICAL TRIAL MANAGEMENT SOLUTIONS CAN HELP IN TIMES OF UNCERTAINTY
1. SUPPORTING AND STAYING CONNECTED WITH PATIENTS AND INTERNAL TEAMS
The FDA guidelines emphasize prioritizing patient safety above all else.
Due to the spread of COVID-19, in-person visits may no longer be safe or practicable. Where it is safe to do so, CROs can explore remote monitoring such as video/tele-visits or home visits. In its recent guidelines, the FDA recognized that protocol deviations may be unavoidable due to COVID-19 and emphasized the importance of documenting each deviation.
With fewer or even no in-person visits, CROs need to implement alternative ways to monitor and stay top-of-mind with patients.
By integrating CTMS with external tools such as MailChimp, Twilio, Calendaring software, Facebook, CROs can:
- create email templates and send bulk personalized emails;
- send mass SMS to patients regarding travel disruptions and delays related to COVID-19; and
- track and segment communications, for instance, to those patients who missed appointments, skipped a dose, or can no longer do in-person clinic visits.
From a patient recruitment standpoint, CROs can:
- automatically track leads to recruit new patients;
- view consolidated lead information; and
- run highly targeted social media campaigns.
From an internal communication standpoint, CROs can:
- communicate using integrated calendars that sync with important study milestones; reminders and notifications; and
- send calendar reminders or updates via segmented email to patients.
2. PROVIDING REAL-TIME VISIBILITY TO SPONSORS
Equally important, CROs must stay in regular communication with their sponsors. Given the current speed of change, sponsors will heavily rely on a CROs ability to provide accurate, complete, and current data very quickly.
Not only are traditional manual processes and maintaining excel sheets time-consuming and cumbersome, but they can also produce inaccurate and incomplete data. As clinical research becomes more data-driven, decision-makers from CROs and sponsors will need efficient ways to make sense of complex and vast data.
By leveraging a CTMS’s reports and dashboards, sponsors can view real-time data to:
- maintain and view enrollment data for multiple studies;
- track adverse events or protocol deviations;
- view and maintain patient visit information at each study and site level; and
- track files and electronic case report form (“eCFR”) responses and data for each patient within a study.
Using robust, configurable dashboards, CROs, sites, and sponsors can effectively visualize the data. Better data-processing enables companies to gain better insights and make more meaningful data-driven decisions.
3. UTILIZING INTEGRATED BUDGETING SOLUTIONS
As CROs begin having difficulty meeting KPIs or project timelines, they may run into financial strain as they may struggle to receive adequate funding from sponsors. In uncertain times, offering transparency to current financial data and future projections will help the CRO remain proactive with their sponsors.
Within an integrated CTMS budgeting solution, companies can:
- track and share budget and variance in real-time dashboards and reports
- track clinical trial cash-visibility by study, site cohort, study arm, demographic, etc.;
- view budget templates for optimal budget allocation at the study and site levels; and
- view financial forecasting based on automated tracking of patient visits, site monitoring, site management to compare budget, actual and forecasted costs.
By staying transparent and providing reliable data, CROs, sites, and sponsors can find mutually beneficial ways to survive the COVID-19 crisis. CROs can request amendments, the release of outstanding holdbacks, or a crisis fee.
The reality is, CROs, sites, and sponsors have a mutual dependence. Delays in getting the device or drug to market can potentially delay revenue for sponsors. As the patent clock continues to run, communication and transparency helps all parties do their part in accelerating the speed to market.
Challenges abound for the clinical research industry during COVID-19. For CROs, those that can adapt and stay connected with their patients and sponsors will be the most resilient in times of uncertainty. By using solutions like CTMS to streamline their processes, companies can then focus on accelerating their return to business.
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- Consult with your sponsor, legal department, data protection officer, and applicable privacy laws.