Coronavirus was first reported in the US in mid-January. Since then, COVID has spread throughout the country and led to significant disruptions across the clinical research industry. In response, sites have significantly modified trial operations and regulatory organizations have released flexible guidelines on conducting trials. While some sponsors have allowed individual sites to continue screening, most have placed enrollment holds on ongoing studies and delayed initiation of new trials.
As we enter a new month, many (including us at CRIO) are wondering when clinical research will return to near-normal conditions.
One site says,
Most sponsors are ready to hit the GO button on screening and enrollment.
– a large research site in Texas
A site in North Carolina revealed that they are scheduled to start a new study by a major sponsor in the next couple of days and that they are already in the greenlight process for another trial. The same site also said that “although the vast majority of our studies are in a holding pattern, sponsors have indicated that they will open screening by early July.”
Another site told CRIO that a major sponsor has set conditions for their being able to resume screening and enrollment. For instance, the site must have IRB approval to restart, appropriate PPE for staff and visitors, ability to conduct study visits on-site, adequate staff to complete study procedures and oversee safety, enough study supplies (IP, lab kits, cleaning), and the ability to conduct on-site or remote monitoring visits with source data verification.
March Update on COVID-19 Reopening from Pharma Companies
Over the last week, many pharmaceutical companies released their first-quarter financials and discussed their plans to open up the research again. The majority also indicated that they plan to return to near-normal operations by the end of the year. Here is a summary.
Astrazeneca noted that there may be delays for phase 1/2 studies, but has already started to recruit new patients for phase 3 studies in areas less affected by the pandemic. They plan to accelerate recruitment once the pandemic has further receded.
Regeneron will continue to monitor the evolving situation but plans to start enrolling new patients in individual trial site locations.
BMS continued some clinical studies as planned and is planning to get suspended or postpone trials running again.
Eli Lilly reopened enrollment for existing trials and has started to initiate new trials. They will be continuing COVID research throughout the year.
Novartis announced a flexible start date of May 11, 2020, for employees to return to the office and restart-onsite field activities. Novartis will be initiating trials for COVID-19 treatments.
Pfizer has already started to reopen some of its stalled trials. This includes new study starts at sites that are currently operational. The company will continue to perform remote monitoring visits and allow virtual visits/home visits where appropriate.
Merck & Co is engaging in COVID research and has allowed sites to continue visits for patients already enrolled in clinical trials. Depending on local conditions, sites will be allowed to enroll patients and the company will start up new trials.
Given this clear trend, sites should be on the lookout for new and re-opened study opportunities. According to clinical trial business development expert, Rachel Truxell, research sites can anticipate a surge in new study awards, especially with the COVID trial bulge. Others are predicting a spike in interest from patients due to large recent job losses. Matt Clair, President of Precision Recruitment, advises that sites should be taking advantage of high phone contact rates to pre-screen patients for trials and get referrals to friends and family. Tom Wardle, CEO of CenExel, also adds that sites will need to “demonstrate to patients how they are taking precautions to minimize their risk of exposure to COVID.”