Since early March 2020, a significant number of companies, including sponsors, collaborators, and clinical research organizations (CROs) began announcing disruptions to planned and ongoing clinical trials as the reality of pandemic-related lockdowns began to set in.
Disruptions included delaying the initiation of planned trials or withdrawing them completely, suspending enrolment of ongoing trials, or terminating these trials altogether.
Covid-19 lockdowns and social distancing measures caused significant disruption to clinical trials and accelerated the use of decentralised or virtual trials. These clinical trials allow the collection of safety and efficacy data from study participants by using a range of digital technologies that require a minimum number of site visits. These trial designs incorporate supporting technologies such as telemedicine, wearable devices, eConsent, electronic clinical outcome assessments and electronic health records.
GlobalData is conducting a survey to gauge the state of decentralized/virtual clinical trials along with the impact the COVID-19 pandemic on clinical trials. We are seeking the opinions of respected industry professionals to participate in a short 5-7 minute survey.
Upon completion of the online questionnaire, respondents will also gain access to a summary of the report findings on project completion.
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Over the past 18 months, many leading CROs and eConsent software providers have expanded their capabilities in response to the growing demand for these virtual services. Several specialist virtual trial providers have emerged in recent years and attracted considerable attention during the pandemic. Companies that had not considered the decentralised model before had no option but to rapidly implement new technologies and procedures to maintain business continuity.
Covid-19 has brought on a digital transformation in the clinical trials landscape, accelerating technological advancements, prompting regulatory relaxations, encouraging the evolution of CROs into virtual trial providers and rewarding an increased focus on patient-centricity. These ongoing trends will continue to boost the movement towards decentralised and virtual clinical trials.
However, this transition won’t be entirely smooth. There remain concerns related to data integrity and privacy, lack of access to suitable devices or high-speed internet, regulatory ambiguity, interoperability between systems, lack of buy-in from stakeholders and high set-up costs, which could all challenge the speed of the uptake.