A new survey of investigator sites reveals approximately 69 percent of respondents said lockdown measures have impacted their ability to conduct ongoing trials and 78 percent said COVID-19 has affected their ability to start new trials.
Only 11 percent of the 1,030 respondents said they were “extremely concerned” about their ability to collect clinical outcomes data during the pandemic. The global survey was conducted by Medidata the week of April 23.
More than half (63 percent) of survey respondents said they have stopped new patient recruitment for an ongoing trial, whereas 43 percent said they have delayed their study. Only 12 percent of sites that responded to the survey have said they cancelled studies.
Nearly 45 percent of respondents said they have switched study participants from in-clinic visits to virtual/telemedicine. Around one-third (33 percent) of respondents said they have amended their study protocol, and another third (32 percent) have said they have not allowed randomization of patients who have completed screening.
On a scale from one to five, with five representing “being extremely concerned,” respondents were most concerned with their ability to enroll (weighted mean: 3.73) and recruit patients (3.66). They also reported concerns about financial implications for cancelled trials (3.42) and patient access to the research site (3.05), among other concerns.
The survey also revealed that only 8 percent of respondents have tested patients for an active COVID-19 infection. Only 3 percent tested patients for prior infection.
Respondents also suggested that decisions to postpone a trial or halt recruitment should be made on a region-specific basis, as COVID-19 is not affecting all parts of the world equally. To ensure they have additional financial support to employ study coordinators during delayed or suspended studies, sites suggested contracts should be amended for increased remote monitoring work and increased overhead reimbursements. Also, sites commented that they want sponsors and CROs to develop study-specific contingency plans to prevent deviations from scheduled visit windows in case another outbreak occurs in the future.
The majority of respondents were from the U.S. (58.3 percent), followed by Asia (23.8 percent), the EU/UK (8.1 percent), South/Central America (7.1 percent) and Middle East/Africa (2.7 percent). Respondents were mostly study coordinators (73 percent), followed by investigators (11.2 percent), directors (5.4 percent), clinical nurses (4.1 percent) and “other” (6.3 percent).
To read the survey, click here: https://bit.ly/2Li3qMt.