In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.
We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.
Although the benefits of implementing it in clinical studies are evident, patient technology has yet to make a clear entrance into the clinical arena, as many trials continue to rely on traditional research methodology.
During a recent Halloran Virtual Town Hall meeting, a panel of experts to share what they are seeing in terms of regulatory activity, as some cases are receiving expedited feedback, while others are experiencing delays in reviews and receipt of commentary from the FDA. This article presents some key insights from the panel’s experience conducting regulatory activities during the pandemic.
It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.
The Beat AML (BAML) Master Clinical Trial was focused on efficiency and speed of operations, not on the coronavirus outbreak or pandemics in general. Yet, the model and technologies used by BAML are applicable for biopharma sponsors who want to adapt their clinical operations to support remote monitoring and faster acquisition of data, while preparing for another outbreak or weathering the current crisis.
For medical product developers, the role of the caregiver is increasing as innovation advances. Caregivers may provide input on clinical trial concepts, protocol design, informed consent creation, and may also improve clinical trial recruitment and retention.
Pivotal first meetings with sponsor representatives or investigational sites set the precedent for future relationship development. They often serve as the introductory vehicle for key study players and require finesse to ensure success. For these reasons, all early interactions are something sponsor companies should pay close attention to.
Quality, as it relates to clinical trials, is defined as an absence of errors that matter to decision-making. Therefore, quality by design (QbD) literally translates into an absence of errors that matter to decision-making by design. This proactive approach to quality continues to gain global and regulatory support. In fact, on May 8, 2019, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft revision of ICH E8 (R1), General Considerations for Clinical Studies.
It can be overwhelming to keep up with the rapid pace of health technology advancement; in many ways, it feels like we’re just along for the ride. Let’s fast forward and take a look into three key areas of innovation that are forcing us to face and embrace a changing technological landscape in clinical research.