Clinical research has been greatly challenged in the wake of COVID-19, with 1773 US clinical trials reportedly suspended as of April 21, 2021. Pandemic-related restrictions on in-person visits created obstacles to trial enrollment, data collection, and intervention delivery. As reported in a recent opinion article by Dr Mary McDermott and Dr Anne Newman, even ongoing trials that were not suspended faced challenges with enrollment and adherence to study protocols that require in-person contact. Some clinical trial investigators overcame these challenges by replacing in-person interactions with remote approaches. In a survey of 245 investigators, remote interactions increased more than 6-fold from January 2020 to May 2020. These remote activities included mailings or drop-offs of devices or pills; use of telephone, web-based, or video interactions; and home or outdoor visits to collect outcomes or administer interventions.
The authors suggested that some of these remote practices may continue after the pandemic, primarily to facilitate trial participation for individuals for whom travel to a medical center is difficult. However, they caution that the integrity of results from remote interactions may be compromised in some situations. For example, patients with cognitive impairment require assistance from a caregiver, which could interfere with the accuracy of cognitive test results. Also, remote interactions may not mitigate all the potential barriers to trial participation, such as insufficient knowledge and concerns about treatment toxicity. Other potential challenges are that some interventions (eg, behavioral) are less potent when delivered remotely, and some outcome measures require bulky equipment, sterile technique, or special skill to obtain, and may be impossible to collect remotely.
Clinical trial investigators should aim to reduce unnecessary travel by participants by employing remote interventions where possible. However, they must also carefully consider the impact of remote interactions on the validity and integrity of the trial. Remote adaptations to obtain informed consent may be hindered by a patient’s comprehension and understanding or an inability to use video at home. Remote outcome measures may not provide the same quality of data collection, since home environments and patients’ ability to perform the measure vary. Lastly, interventions that rely on mail delivery can be problematic for maintaining or monitoring adherence, particularly for patients in rural areas. When designing and conducting clinical research, each of these considerations must be weighed against the potential enrollment benefits of offering remote interactions.
Remote interventions enabled some clinical trials to continue during the pandemic. The same remote adaptations used in clinical trials may also apply to individual patient care. Clinicians must weigh the potential benefits of remote patient care against the potential challenges, such as variances in the ability of patients and caregivers to accurately self-administer interventions or monitoring tests. Each case should be evaluated on an individual basis before implementing remote practices.