Every clinical trial team must strive to conform to the standards of Good Clinical Practice (GCP). Maintaining this standard of scientific and ethical quality is crucial to ensure patient safety, maintain regulatory and legislative compliance, and guarantee the integrity and validity of trial data.
It is the role of quality assurance (QA) departments to safeguard the clinical trial process and ensure that these rigorous standards are met. The role of QA has only been highlighted by the stresses of the COVID-19 pandemic and the rush to develop a vaccine.
Let’s discuss the importance of quality assurance in clinical trials, and explore how teams can use virtual engagement to support the QA process.
“Quality assurance (QA) in clinical trials is a safeguard against non-compliance, which impacts patient safety and data integrity.”
Journal of Clinical Oncology
Prioritizing patient safety
Patient safety is always a priority for clinical trial teams, but the QA process is key in determining whether there are gaps in an institution’s patient safety culture, and in assessing risk.
QA departments might assess the following when considering patient safety:
- Whether care providers have the capacity to maintain patient safety standards
- Whether sites are sufficiently accessible for seniors and patients with mobility issues
- Whether initial health assessments (IHAs) are being carried out consistently
- The quality of care provided
Unsurprisingly, the COVID-19 pandemic had a transformative impact on the role of QA in maintaining patient safety. The virus significantly increased the risk of site visits to both participants and clinicians and placed additional demands on clinical teams. On top of that, the need to develop an effective vaccine in as short a time as possible meant trials were implemented rapidly, with a potentially detrimental impact on quality. In a clinical landscape transformed by the pandemic, virtual engagement platforms can help to support QA processes and maintain patient safety.
“To future-proof studies… new processes and technologies can be implemented to reduce unnecessary human-to-human contact.”
Applied Clinical Trials
Guarding against non-compliance
Increasingly, pharma companies have looked to outsource clinical trials to other nations as a means of saving time and resources. However, each different country has its own unique healthcare system, set of standards, and ethical practices. With all these factors in play, ensuring regulatory and legislative compliance and consistent GCP is a significant challenge.
“The globalization and outsourcing of clinical trials have made the target of achieving global quality trying and tough.”
QA ensures institutional standard operating procedures (SOPs) are being followed consistently across all sites, and that potential non-compliance isn’t putting patients and clinical findings at risk. Baking quality assurance into your clinical trial-related activities from the start allows QA departments to identify and troubleshoot problems and quality issues before they pose a risk, helping your institution avoid potential reputational damage and financial loss.
“Auditors should also keep in mind the quality standards of nations other than the United States, such as the recently implemented EU Clinical Trial Directives.”
James Lind Institute
Ensuring data integrity
Part of the remit of GCP is to maintain a culture of excellence across the pharma industry. In the clinical trial process, that includes the capture of reliable, accurate clinical data. The independent monitoring provided by QA departments ensures that clinical trial data processes are being carried out appropriately – from data generation and recording through to analysis and reporting – helping to uphold that culture of excellence.
“Quality assurance facilitates continuous improvement in clinical research through internal audits, policy and procedure creation, and support of corrective and preventive actions from external audit findings.”
The QA team helps to ensure that clinical trials are fit for purpose and that the data being gathered is the data required to address fundamental clinical research questions. Again, the COVID-19 pandemic increased the pressure to maintain data integrity. The search for a safe, effective vaccine was dependent on reliable clinical trial data, gathered at pace against a backdrop of risk and uncertainty. QA processes were vital in maintaining a safe, compliant environment where high-quality clinical data could be generated.
“Every data query costs an average of $150.”
Applied Clinical Trials Online
Virtual engagement and quality assurance
Technology is playing a critical role in the design of clinical trials with quality baked in from the start. Through asynchronous virtual engagement, clinical teams can reduce in-person contact and minimize risk to both participants and staff – helping to address QA requirements for both patient safety and compliance. The insights management platform works to engage all crucial stakeholders throughout the trial process, capturing critical feedback to optimize trial design and execution. With the right platform behind them, clinical teams are able to design clinical trials capable of delivering highly successful outcomes.
Check out our Guide to Successful Clinical Trial Design to learn more about using technology to support quality assurance in clinical trials.