As clinical trial professionals confront unprecedented new obstacles and realities during the coronavirus epidemic, leaders in the field are stepping forward to offer tips and tactics to help mitigate the crisis. The key is to assess the situation day after day, week after week.
“Plan for the worst, but do your best to protect study data integrity,” says Anne Blanchard, CCRA, a clinical research executive consultant with LATINABA in Argentina and member of the Association Board of Trustees for ACRP.
“In general, each protocol will need to be reassessed,” Blanchard notes. For protocols with primary or secondary endpoints that were evaluated onsite and where a global or central vendor is validating the evaluation process, this will need to be discussed with vendors if the administration format or key procedure can be done and validated in a remote way. This will not always be possible, she adds.
“Good communication among all people involved in the study in real time is key,” Blanchard says.
As a clinical trials veteran, Blanchard offers 10 valuable tips:
- Sites and Sponsors: Review/submit addendum with consent language for approval to ethics committees/institutional review boards (ECs/IRBs) with changes that impact new procedures.
- Sites: Request EC/IRB approval for site-to-subject shipments and temporary use of telephone visits until subject can/will return onsite. For example, re-consent subjects by phone; collect signature by e-mail.
- Sites: Conduct telephone visits to review investigational medicinal product (IMP) compliance, adverse events, and other patient-focused study details per protocol.
- Sponsors/Clinical Research Associates (CRAs): Proper source documentation verification (SDV) practice may still be required. Keep a detailed track of what SDV actions are pending to be covered when possible.
- Sites and CRAs: Protocol deviations and safety events will still be reportable per protocol to ECs/IRBs, so review the trial processes and timelines with them. Be careful to document all deviations appropriately and explain as needed.
- Sponsors/Contract Research Organizations (CROs): Adapt monitoring to cover what is possible with remote communications if site staff are available. Keep track of the SDV pending that needs to be done onsite for future reconciliation.
- Sites and Sponsors: Evaluate site-to-subject IMP shipments. This will be aided through access to the vendor-supported standard operating procedure (SOP) (preferred) or the institution-approved SOP being tracked by CROs. Note: this may not be possible in all countries.
- Sites and CRAs: Check the supplies of clinical trial materials in advance as shipments may experience delays.
- CRAs/Sponsors: Create web-based meetings with sites to discuss adjustments and issues that may arise when conducting studies under these new conditions.
- CRAs/Sponsors: Check with the central lab vendor to see if it is possible to do home visits to patients. Assess study resources at the site and ensure the availability of staff and communication plan coverage of all study subjects, to ensure their welfare and help patients adhere to protocol as much as possible. Collect credentials and train and delegate new study staff if needed.
Blanchard’s final piece of advice is to review carefully to ensure that any adjustments are approved by the sponsor and CRO (if applicable), and to ensure that all modifications are submitted for IRB approval if required after sponsor approval and before implementation.
Elsewhere, a Certified Clinical Research Coordinator (CCRC) who asked to remain anonymous says all therapeutic research that does not involve COVID-19, life-saving measures, or remote implementation is suspended at her institution, though there is an exemption process. Enrollments are frozen unless they meet these criteria (e.g., no patient visits for research). “We have been able to use telehealth for follow-up visits (which will also include protocol deviations),” the CCRC says.
However, there will absolutely be a delay in patient enrollments, if any direct contact is needed, the CCRC says. “Trials requiring blood samples/lab work/direct patient interactions will be greatly affected,” she notes. “We’re doing the best we can, taking it one day at a time.”
Author: Michael Causey