PPD’s trial network unit Accelerated Enrollment Solutions (AES) is rolling out a new program designed to help biopharmas keep their clinical trials going.
As the COVID-19 pandemic continues to hit the world hard, trials have been a particular victim of the lockdown methods used to help keep back the virus’ march, with almost all major pharmas and biotechs delaying or stopping their drug tests.
To try and find a way around this, AES has set up a new program that sees it transferring clinical trial patients to its research sites from other trial facilities hit by the pandemic.
It says that this patient-transfer program is “designed to address this issue through its global site organization, which includes dedicated research sites committed exclusively to clinical research.”
FierceCRO spoke to Roger Smith, the general manager at AES, about just how this program would work. He explained that through this program, the company can offer “a physical site location that is proximate to the patient and where the protocol and associated study visits can be performed by our sites and staff.
“With a network of more than 180 locations in the major clinical trial population centers in the U.S., EMEA, Latin America, India and China, we can offer a variety of opportunities for participants to continue in their trial.”
On a practical level, Smith said it will work like this: The AES project manager works with the sponsor, CRO, principal investigator and site staff to obtain their consent, inform the patient of the site change, confirm that the transfer is appropriate for the patient and gather study records and contact information.
Then, the AES staff conducts a digital consent visit with each patient to complete the transfer, with the company and the sponsor arranging investigational product delivery details. After this, AES and the sponsor configure vendor systems and devices (using transfer concepts like “PatientShare” and “PatientTransfer”) to ensure patient continuity data in the electronic trial master file.
The sponsor/CRO can conduct a remote site initiation visit, if necessary, and regulatory filings occur simultaneously, per the new FDA and EMA COVID-19 guidance.
Smith points out that as its sites are research centers and not hospitals or clinics, coming into contact with COVID-19 contagious patients is a much lower risk, making it safer for patients to transfer.
More specifically on safety, he said: “Our ‘COVID-19 SMART’ program ensures that our sites adhere to all COVID-19 safety precautions (temperature checks, handwashing, social distancing, use of personal protective equipment, etc.) for staff and patients prior to and upon their arrival at the site.”
Smith added that in the course of normal business, it’s “not unusual” for patients to transfer to new sites, so this is “just an amplification or extension of that process.”