Responding to COVID-19 Continuity Challenges
Diego Glancszpigel, Vice President Global Account Management, Accelerated Enrollment Solutions | a business of PPD
In light of the COVID-19 pandemic, the pharmaceutical industry is facing numerous challenges to its clinical trials, as research sites and hospitals reprioritize their staff to support frontline medicine, and patients exhibit a reduced ability or willingness to participate in research. AES offers sponsors an alternative to postponing or cancelling studies.
AES sites are dedicated to clinical research and have the capacity to support ongoing trials now and help customers gain back any lost ground after the crisis has passed. Here are some ways AES can support existing or planned trials.
Transfer of Patients to AES Sites
Our sites, which include 180+ locations in 17 countries, are open and ready to receive patients from study sites that are unable to continue their current trials. The transfer of patients to AES sites supports patient participation and allows for continued trial data collection. And no additional major costs are incurred, because investigator fees have been budgeted and allocated for trials already in progress.
Patient Ability/Willingness to Participate in Research
AES offers rapid evaluation and implementation of creative solutions to address patient concerns about participating in clinical trials. For example, remote screening processes are available to assess patient eligibility, including call center pre-screening, online pre-screening and virtual pre-consent visits. Both patients and staff have taken part in our video visit capabilities.
We have proactively implemented COVID-19-specific procedures and policies at our sites to put patients at ease.
At AES, we are providing flexible, patient-oriented solutions to achieve results for clinical trial sponsors at a time when trial continuity is at risk.
And we provide in-home capabilities such as options for home health care visits, home delivery of the investigational product, etc.
Gain Back Lost Ground Post-Crisis
AES also provides the ability to help pharmaceutical companies gain back lost ground in patient recruitment after the COVID-19 pandemic ends. With the AES virtual study startup process, we can prepare sites now for enrollment activation post-crisis, using our:
- Remote pre-study visits
- Global, centralized final site verification process
- Remote site initiation visits
- Study-specific training
- Global process oversight
AES China Can Fill Patient Gap
Our patient recruitment capability in China never stopped, even at the height of the pandemic there. And when sites in other parts of the world are facing enrollment challenges and/or losing patients, we can help fill the patient gap in China. The AES China team talks about its capabilities and current readiness in this video.
Conclusion
AES is employing all of the tools at its disposal to ensure study continuity and provide accelerated enrollment both during and after the current crisis, with emphasis on:
- Providing remote site startup visits
- Expanding patient telehealth and virtual solutions
- Accommodating patients from non-AES sites that are unable to focus on or support current trials
- Offering in-home solutions
The overall benefits to pharmaceutical companies include maintaining required data continuity, allowing current patients to continue their research commitment, and being able to utilize AES sites worldwide to screen and enroll additional patients as needed.