When a small international company approached Westat in 2020 to conduct a phase I solid tumor study, the World Health Organization had just declared the COVID-19 outbreak as a global pandemic.

Streamlining Study Start-up

The plan was to enroll the first patient by the end of June, two months after the contract was signed—an ambitious goal even under normal circumstances.  Westat’s cadre of highly qualified staff allowed us to rapidly assemble a team with expertise in clinical, data management, data analysis, pharmacovigilance, and regulatory practices. Our broad range of Standard Operating Procedures (SOPs) and library of customizable tools and templates ensure that we are able to quickly develop quality products.

Our team created project plans that met ICH E6 requirements, including a study monitoring plan, quality management plan, and a risk monitoring plan.  We used standard templates to streamline the development of the CDASH- compliant eCRFs and database.  Our implementation of the Medidata Rave, Coder and Safety Gateway allowed rapid reporting of SAEs.  We met our internal goals of training on the protocol and contract requirements and reviewing critical paths to enroll the first patient by June 30.

Accelerating Site Initiation

Since on-site visits could not be conducted, Westat staff quickly developed tools for assessing site qualification and conducting protocol training.  We also worked closely with the site staff to ensure we gained IRB approval as well as coordinated the activities of two laboratories and the study drug and laboratory kits suppliers.

Reporting Critical Data

Westat had to verify that remote monitoring could be conducted in accordance with ICH-GCP, regulatory requirements and protocol, while establishing agreements to access protected health information.  We developed processes to access source documentation including procuring document sharing software with ‘auto-redact’ functionality.

Timely monitoring of participant data was critical, so that our team could report results to the Safety Review Committee (made of the medical monitor and the PIs). Once the first patient was dosed, we needed to provide accurate and complete data the committee could use to make decisions about continuing the study, increasing the dose after safety requirements were met for the prior dose, or even proposing a reduced dose if problems occurred (either for one participant, or for all future enrollments.

Additionally, we prepared tables and listings that summarized the safety data needed for the Development Safety Update Report and we worked closely with site staff to make sure critical data was entered and reviewed as quickly and efficiently as possible to ensure complete, accurate reports.

Responding to the Unexpected

In addition to navigating the ongoing challenges encountered during the pandemic, we also prepared for unexpected events by developing contingency plans so project timelines were protected.  Two protocol amendments resulted in updates to the study plans, database, and reporting. Our ability to respond nimbly to these developments meant that updates were completed in a way that did not affect the enrollment schedule.  Our trusted relationships with suppliers also enabled us to quickly provide the kits and drugs the sites needed.  As a result of our tested teamwork and efficient processes, we met the original timeline for patient enrollment in the first 6 dose cohorts.