Diverse technology solutions, like patient telehealth visits, accessing electronic medical records (EMRs) or remote source data verification, can generate vast amounts of data. As the clinical research industry evolves towards its next “new normal” with a higher baseline level of remote monitoring, IQVIA is considering the implications of increasing data access. COVID has revealed gaps in how regulators approach data use, but also informs a path forward.
The challenges of a pandemic-level disruption, for example, may result in situations where databases are closed without the source data being monitored in the intended fashion. Regulators will need to be ready to deal with these risks and resolve challenges. Despite the initial responses of CROs and technology companies, suddenly operating in unprecedented times of the COVID-era, submissions must be kept consistent. Clinical development must continue. Pharmaceutical innovation cannot stop.
IQVIA sees requirements for remote data verification and electronic access for remote data monitoring as an opportunity to improve alignment with regulators and improve the conduct of clinical research in ways that improves efficiency across the clinical development landscape.
IQVIA has locked more than 20 studies during the COVID-19 pandemic, crossing multiple therapeutic areas including cardiovascular, oncology, gastroenterology, internal medicine, women’s health and neurology. A variety of strategies were employed to enable successful database locks and submissions to occur, as well as to close the study and complete study close out visits, which could be leveraged in the future:
- Strictly adhering to a well-defined monitoring visit guidance that allowed for remote visit conversion
- Allowing for remote data verification (where allowed), remote data monitoring, and remote data surveillance
- Reducing source data verification requirements based upon risk, including a determination of the impact on data and safety parameters
- Reducing and/or prioritizing queries and query resolution/answers requirements based upon risks of impact to critical data and safety parameters
- Delaying close out visit dates until post-database lock, for when sites could be available for onsite and remote monitoring, and combining close out visits across studies where possible
- Documentation of decisions and any protocol deviations or changes to clinical operations plans and rationale
Improving regulatory alignment around remote monitoring and access to site and subject data enables the clinical research industry to better deliver technology solutions that help patients – both in times of pandemics and as a new, improved status quo. Nicole Connelly, Senior Director of R&DS Strategy and Innovation at IQVIA, sees an imperative to push for progress. “Before this happens again, we have an opportunity to do things differently. We know that this can be done. The risk is that we go back to doing things the old way.”
This is Part 2 of a 3 part series. Next: Part 3 – Novel ways to engage with patients