IN PARTNERSHIP
controlled temperature shipper and a temperature- tracking device to ensure IPs maintains the correct temperature in transit. Site staff is available to assist with courier pick-up, and IP shipping preparation and strategies addressing the absence of on-site staff are in place to mitigate shipping delays and IP integrity. If the staff is unable to be on-site to coordinate
DTP pick-up, IPs can be shipped directly from the depot to the patient’s home. At this time, Rho has not had to implement its secondary shipment strategy. Furthermore, using monitoring approaches, guided by the risk assessment, enabled Rho to make decisions around the most appropriate use of monitoring strategies; including, risk-based monitoring, central monitoring, off-site monitoring and targeted site data verification. For this study, a highly effective combination of remote and centralised monitoring was implemented.
Remote and centralised monitoring Remote monitoring visits are used only in cases where on-site monitoring cannot otherwise be conducted. The need for remote source document verification was determined by calculating the backlog of pages and how many days it would take for the clinical research associate to get caught up. Based on this assessment, it was determined that only one site would require remote source document verification. The remote monitoring visits for the other sites
focus on confirming that sites are reconsenting patients with updated informed consent forms (ICFs), resolving open action items and ensuring patient safety is being maintained. The team will continue to monitor and reassess the need to perform remote source document verification if on-site monitoring visits continue to be not permitted. During this study, Rho is using remote evaluation of clinical data carried out by various study team members. Centralised monitoring is used to identify trends, including information pertinent to site management activities and identifying trends in safety events to expedite appropriate management. Since on-site monitoring was delayed due to
Covid-19, the company increased the frequency of its reviews and added a key quality indicator specific to remote patient visits. Additionally, it created a new monitoring visit schedule specific to remote interim monitoring visits, which are being conducted more frequently than the previously scheduled on-site visits.
Time to update To document the Covid-19-related changes, Rho amended the protocol; for example, visits may be performed via telemedicine or home healthcare assessments applicable for remote patient visits. According to ‘FDA Guidance on Conduct of
Clinical Trials of Medical Products during the Covid- 19 Public Health Emergency’, “Changes in a protocol are typically not implemented before review and approval by the IRB [institutional review board]/ IEC [independent ethics committee], and in some cases, by the FDA. Changes to minimise or eliminate immediate hazards or to protect the life and well- being of research patients (for example, to limit exposure to Covid-19) may be implemented without IRB approval or before filing an amendment to the IND [investigational new drug], but are required to be reported afterwards.” The company updated the ICF to inform the patient of changes related to Covid-19. In light of the Covid-19 pandemic, changes may be implemented prior to patients signing the updated ICF. All Covid-19-related data is also included in the
electronic data capture migration. Adding these data points explains the basis for missing protocol- specified information that includes the relationship to Covid-19 and is critical in creating robust analyses and shortening future study timelines. To date, Rho has been able to successfully facilitate
43 DTP shipments, conduct 95 remote visits – which fluctuate daily – and meet the same study timelines and retention rate metrics that were established prior to the pandemic. But its greatest success comes with the preservation of its strong site relationships. Due to its partners’ willingness to be adaptive, facilitative nature and prioritisation of patient care and safety, these relationships have only grown stronger amid this new and ever-changing Covid climate.
The right solution Decentralised solutions are not one-size-fits-all. The right solution for a trial or programme should be determined and managed using a robust risk- assessment process, which will identify risks upfront and monitor them throughout to let the client know when changes need to be made. To fully realise all the advantages and benefits of a truly decentralised approach, partnering with a reliable and experienced CRO to implement and execute a decentralised solution is critical. ●
www.rhoworld.com Outsourcing in Clinical Trials Handbook | 49
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