As virtual clinical trials have found popularity, some sponsors and researchers have been hesitant to embrace it wholeheartedly. The COVID-19 pandemic has proven to be a universal disruptor in the traditional clinical trial model, and the bio-pharmaceutical industry has been forced to find new and innovative approaches.
As a result, the virtual trial is now perceived as a viable alternative to traditional trial methods. While the traditional method heavily relies on the in-person collection of data at sites, virtual trials make it possible for patients to be home-based and participate in the clinical trial process virtually.
Things to consider before setting up a virtual clinical trial
While technologies are available at your disposal, the transformation from traditional mode to virtual mode, may be challenging. Apart from understanding your organizational capabilities, there are various other factors to consider if you are planning to make this transition.If you are considering making the shift, here are certain things to ponder upon.
Is your organization ready for the transformation?
In 2020, Johnson & Johnson launched two complete virtual trial programs. It’s been observed, one of the biggest hurdles for an organization to embrace virtual trials is not technology, but the maturity of the organization and its readiness to adopt a new approach. To make this transition, organizations will be required to dissect their entire trial processes and procedures, analyze each step, determine requirements, and stage of readiness to move forward.
Understand the impact on stakeholders, especially on patient recruitment and enrolment
Shifting to a virtual trial will affect stakeholders differently. It is important to understand how these changes may affect the stakeholder experience. For example, moving from in-person visits to virtual visits may not be difficult for site staff, yet may drastically change the participating patient’s experience. it may be more challenging to make that shift for studies that require complex testing, procedures, and/or drug administration.
With the challenges of recruitment and retention, with as much as a 40% drop-out rate, virtual trials eliminate geographical limitations, and reach a broader area of patients interested in participation.
Understand global regulatory implications
For any organization considering this transition, it is important to understand the regulatory implications and consider the relevant federal laws and regulations that may be impacted. While regulations governing clinical trials in the US and EU allow electronic submission of clinical trial reports (with few exceptions), this might not be the case in other countries and territories.
Setting up the infrastructure
After considering the above factors, sponsors and research organizations should ensure the proper infrastructure support and resources are available. It may sound overwhelming to transition to virtual trials, you are not alone in ensuring the right technologies are in place. Engaging and collaborating with technology companies will lead to better outcomes.
Virtual clinical trials have already demonstrated abilities such as reducing the burden of participating patients, reaching patients beyond a geographical limitation, and managing the robust collection of data. Does your organization understand their capabilities and readiness to embrace virtual clinical trials?
Cloudbyz Unified Clinical Trial Management (CTMS) is a comprehensive, integrated solution to streamline clinical trial operations. Built on the Salesforce cloud platform, our CTMS provides real-time visibility and analytics across study planning, budgeting, start-up, study management, and close-out. Cloudbyz CTMS can help you achieve greater efficiency, compliance, and quality in your clinical operations with features like automated workflows, centralized data management, and seamless collaboration. Contact us today to learn how Cloudbyz CTMS can help your organization optimize its clinical trial management processes.
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