Adapting Clinical Trial Operations in Response to COVID-19

With millions infected and casualties in the hundreds of thousands, the novel coronavirus has taken a significant toll on human health. It has also crippled economies and left millions without jobs. Now, there is immense pressure to find a treatment for COVID-19.

Sponsors, with support from regulators, health authorities and governments are starting COVID-19 clinical trials at record pace. There is also the need to safely provide ongoing care for patients enrolled in existing clinical trials for serious illnesses, such as cancer treatment.

If anything, COVID-19 shone a light on the vulnerabilities of today’s clinical trial operations. Across the board, functions ranging from investigational product management, clinical trial monitoring and trial management in general need to adapt.

COVID-19 as a Catalyst for Change

Overcoming resistance to – even fear of – technology is the way for clinical trials to operate safely and efficiently today and in the future. Now, more than ever, clinical trials need to be digital. The latest clinical trial information must be used to guide decisions, making it even more critical that communication is targeted to the right monitors and research staff at the right time.

Traditional approaches to clinical trial monitoring are proven to be vulnerable with COVID-19 disruptions. A risk-based strategy supported by the right technology allows monitors to respond faster to data that shows potential risk and to better support their sites.

Clinical trials are vital for evaluating and advancing medical and patient care. We can’t go back to the “old way” of doing things. With the pandemic as a catalyst for change, now is the time to modernize and simplify clinical trials.  

Teckro clinical trial software provides a digital engagement platform to connect study stakeholders with the information they need, when they need it. With immediate access to critical study information, sites enroll the right patients faster and have fewer deviations. 

Considering the challenges with COVID-19, Teckro can be applied to both accelerating infectious disease trials and preserving clinical trial continuity.

Accelerating Infectious Disease Trials

Accelerating infectious disease trials requires a new level of coordination and communication among research staff, sponsors and monitors to balance speed, safety, data quality and integrity. The use of paper-based study documents and onsite monitoring are not practical in fast-moving infectious disease trials. Personal Protective Equipment (PPE) is hardly conducive to consulting a protocol in a binder or a desktop portal. 

Teckro connects research sites, monitors and study teams so that only the most current study information is guiding decisions during infectious disease trials:

• Immediate Answers. From any digital device, answers from the current protocol and other study documents are immediately available to anyone involved in the study. Study managers have visibility into what is being searched, which can help identify the need for clarification or potential safety risks. Search activity is also a good indication of site engagement.
• Real-Time Communication. Teckro flags important study messages for users to make sure they don’t miss them. Study managers also have visibility into who is opening their messages, so they can be sure critical updates, such as safety holds, are reaching site staff and monitors. 
• Timely Guidance. Teckro can help study teams coach research staff in carrying out procedures correctly. Useful tips and clarifications can be added to Teckro and shared broadly or targeted to specific sites, monitors, or both. Site staff and monitors can initiate messages back to study teams to get answers and guidance beyond what is available in the study documents. 

Preserving Ongoing Clinical Trial Continuity

Considering the scale of COVID-19 disruptions, risk-based contingency planning must protect patient safety and preserve data integrity. Teckro's digital engagement platform supports everyone involved in the study:  

• Immediate Answers. The usual research staff may not be available to treat patients, so additional medical and home healthcare staff may need to conduct assessments and procedures. Staff who may not be routinely involved in clinical trials need immediate, accurate answers to properly manage patient care.
• Real-Time Communication. Regulators understand that protocol deviations are inevitable in this volatile environment. However, documentation and communication of these changes are vital. Monitors must be kept informed in real-time of changes and they must in turn have real-time communication with site staff. 
• Timely Guidance. Alternative approaches may be needed, such as methods and locations for safety assessments and delivery of investigational products. Staff must understand the procedures and data requirements, guided by current study information.