Remote and flexible trial approaches have been a hallmark of clinical trials during the pandemic and are widely believed to have been the primary factor in keeping trials open and operating. There is evidence showing that such measures as telehealth visits, off-site diagnostic/monitoring procedures and remote consenting were at least partially responsible for the ability of lung cancer trials to weather the storm.
A new study conducted by the IASLC found that although enrollment in lung cancer trials dropped by 13 percent in the U.S. and 14 percent globally from 2019 to 2020, newly adopted decentralized trial measures helped these trials keep enrolling participants and moving forward. With this proof of concept, the study’s authors say, the trials industry can be confident in applying such measures to strengthen trials even after the pandemic ends. Mitigation strategies were employed and, even though the pandemic worsened, trial enrollment began to improve. A more flexible approach — removing unnecessary barriers — may improve enrollment and access to clinical trials, even beyond the pandemic.
Assessing monthly enrollment data from 294 lung cancer trials in 2020 and comparing them to the previous year, the researchers found that single-site trial enrollment was significantly impacted by the pandemic between April and June 2020. In the first three months of 2020, multisite trial enrollment took a notable hit as well. The hurdles raised by the pandemic were significant; more than half of sites saw moderate or greater impacts on their phase 1 to 3 lung cancer trials, the survey shows. Challenges were seen most in chemotherapy (52 percent of sites), immunotherapy (51 percent) and targeted therapy trials (38 percent); as expected, trials of infusion drugs appeared to be hit harder by the pandemic than those for targeted therapies. Sites were permitted to select all responses that applied in the survey.
Sites named telehealth visits, remote patient-reported symptom collection, off-site diagnostic/monitoring procedures (all 85 percent) and remote consenting (89 percent) as the most effective mitigation strategies they used, but not all sites questioned used these approaches. The most frequent strategies implemented by sites to keep patients enrolling were modified monitoring requirements (47 percent of respondents), telehealth visits (45 percent), phone visits (42 percent) and mail-order drugs (25 percent), according to the IASLC survey. In addition, some sites allowed patients to do laboratory (27 percent) and radiology (21 percent) tests at off-site facilities, and a lesser portion moved to alter their consent processes (10 percent) or use eConsent (11 percent).
IASLC’s site survey also shed light on the biggest pandemic challenges faced in lung cancer trials. The most frequent issue identified as moderate or greater was a lower number of eligible patients (63 percent), followed by protocol compliance (56 percent) and trial suspensions (54 percent). Unsurprisingly, sites named fear of COVID infection (89 percent) as the top patient challenge during the crisis. Other deterrents included willingness to visit the site (59 percent), ability to travel (54 percent) and site access (49 percent), as well as securing transportation (38 percent) and lab/radiology access (16 percent). The pandemic forcing researchers to quickly adapt their trials has created some momentum to apply lessons learned and make trials more flexible across cancer types.
Reprint Courtesy of CenterWatch
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