The current, traditional clinical trial model is outdated and is causing issues for patients, trial sites and sponsors. These issues include low recruitment and retention rates, leading to trial delays and increased costs for sponsors. Recruitment and retention or accrual issues are normally due to the distance from a patient’s home to a trial site, the number of visits required, complex trial protocols, lack of patient support, and little or no reimbursement of expenses. Virtual clinical trials use digital technologies and other processes that differ from traditional trial models to bring research closer to patients’ homes and improve their experience by reducing or even eliminating the number of physical site visits required.
Examples of digital technologies used in virtual trials include e-consent, telemedicine, electronic clinical outcome assessment (eCOA), remote patient monitoring (RPM) and wearables. Other processes include direct-to-patient (DtP) shipping of drugs and other supplies to a patient’s home, as well as in-home care with mobile nurses.
According to GlobalData’s Clinical Trials Database, almost 14,000 clinical trials were suspended, terminated or withdrawn between 2011 and July 2021. The main reason given for these trials ending was low accrual rates, as seen in 3,923 trials (28%). This is followed by other reasons (27% of trials) and unspecified reasons (23%), while a lack of efficacy was cited as the reason for 7% of these trials. Looking specifically at the proportion of trials by end date that were stopped or suspended due to low accrual rates compared to all stopped or suspended trials, the percentage has decreased somewhat over the past ten years, from 32% in 2011 to 19% in 2020 (Figure 1).
Data from GlobalData’s Clinical Trial Database also show that the proportion of clinical trials using virtual components has increased from 1.3% of all trials in 2011 to 3.5% of all trials this year to date. When these two datasets are combined, the decrease in issues that can cause low accrual rates could be attributed to the increased use of virtual trial components (Figure 1). These results correlate with the results of a 2020 study by the Tufts Centre for the Study of Drug Development, which found that recruitment rates for trials improved between 2012 (47%) and 2019 (77%). Study researchers attributed this improvement to increased use of virtual trials and mobile data collection devices, as well as more involvement of patients in protocol development.