During the COVID-19 pandemic, it’s taken an average of 7.5 months for pharma and biopharma organizations to implement a decentralized trial from protocol redesign to first patient televisit, according to a new survey from PPD. 

The survey showed that up to 63 percent of respondents said COVID-19 had a “substantial” impact on their ongoing trials, and 15 percent said the pandemic had a “transformational” impact on their ongoing research. Only 1 percent said it had no impact, while 21 percent said it had a “limited” impact. More than half (53 percent) of the respondents said the pandemic had a “permanent” impact on their ongoing trials, but the remaining 47 percent said it resulted in only a temporary reaction. 

Respondents said that 69 percent of their trials in 2019 were designed to be on-site only, but that figure dropped to 41 percent for trials continuing into the first quarter of 2020. Likewise, 20 percent of clinical trials in 2019 were enabled for a hybrid digital design compared with 39 percent in the first quarter of 2020. Only 11 percent of trials in 2019 were designed to be fully decentralized vs. 20 percent in early 2020.

The most impacted areas of clinical trial operations during the pandemic, according to 57 percent of respondents, has been patients’ ability to visit investigator sites. This was followed by sites’ operating capacity (35 percent), on-site monitoring access (32 percent), recruitment and retention (28 percent), obtaining patient consent/reconsent (17 percent), clinical supply chain interruptions (16 percent), data collection and quality (14 percent) and regional regulatory hurdles (6 percent).

Approximately 69 percent of respondents said remote site visits/monitoring are currently being implemented or are planned for implementation in an effort to mitigate the impact COVID-19 has had on their ongoing trials. Another 60 percent of participants said they have started or plan to reduce the number of site visits. 

Up to 48 percent of respondents attributed remote monitoring as having the most positive impact on the performance of their trials. Another 45 percent cited electronic clinical outcome assessments as having the most positive impact on trial performance. Also mentioned in responses to this question was remote eConsent (42 percent), televisits (41 percent), home healthcare (37 percent), and direct-to-patient and direct-from-patient services (35 percent).

The majority of survey respondents (63 percent) said decentralized trials during the pandemic have matched expectations for reducing burden for patient participation. Half of the respondents said decentralized trials have matched expectations for increasing patient access and diversity. 

In terms of benefits, 19 percent of respondents said decentralized trials have led to limited trial interruptions, while another 18 percent said a decentralized trial design has added extra convenience for patients. Reduced operational costs were cited as a benefit of a decentralized approach by 16 percent of respondents. Most respondents (79 percent) said they believed decentralized trials can have the same or higher level of data quality and quantity compared with traditional trials. 

When asked for feedback on decentralized trials, clinicians rated education and training for older patients as a top priority. On the patient side, the top-rated response regarding decentralized trials was the willingness of adoption and excitement about new experiences.

The survey included pharma/biopharma companies from North America (60 percent), Europe (30 percent) and the Asia-Pacific region (10 percent), all of which outsource their clinical research services to contract research organizations. 

To read the full survey, click here: https://bit.ly/2JWK0iT.