New ACRO Report Introduces Quality-by-Design, Risk-Based Framework for Decentralizing Clinical Trials
September 1, 2020 – (Washington, DC) – Clinical trial activities have traditionally centered around trial sites where patients travel for participation. This approach can place a time or cost burden on patients, creating an inconvenience that can limit enrollment speed or trial completion. To transcend these limitations, clinical researchers are continually identifying ways to leverage emerging mobile technologies and increased connectivity within decentralized clinical trials (DCTs.)
With these new, innovative clinical trial approaches comes the need for clear-cut methods to design, execute and refine trials appropriately. Recognizing the importance of mitigating uncertainty around creating and implementing DCTs, the Association of Clinical Research Organizations (ACRO) and its member company Decentralized Clinical Trials Working Party today released tools outlining industry best practices.
“We are very pleased to issue ACRO’s White Paper Decentralizing Clinical Trials: A New Quality-by-Design, Risk-Based Framework” said Karen Noonan, Senior Vice President of Global Regulatory Policy at ACRO. “The paper and the accompanying toolkit provide a set of operational best practices for the implementation of decentralized clinical trials that will be helpful to sponsors and research organizations as we increasingly see technology-enabled trials that reduce burdens on patients and research sites alike.”
The toolkit includes:
- Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralized Clinical Trials, which contrasts a conventional trial with a DCT to examine unique aspects and provide a framework for quality each step of the way
- Decentralized Clinical Trials (DCT) Risk Assessment Considerations spreadsheet, which aims to complement (not replace) organizations’ current risk assessment tools
“We believe the ACRO Quality-by-Design Manual and Risk Assessment Considerations template will help mitigate uncertainty and reduce the hesitation that has slowed the adoption of decentralized clinical trial models,” said Fiona Maini, Chair of the ACRO Decentralized Clinical Trials Working Party.
The COVID-19 pandemic has further highlighted the value and necessity of elements of DCTs; now, a set of general principles is available to guide effective, patient-centric planning and execution.
“Decentralized trials have provided the pathway – where appropriate – to continue to service patients and to keep trials up and running despite site access limitations during the pandemic. ACRO members were able to quickly adapt by using innovative DCT tools to collect patient data during this time, including remote monitoring techniques, telemedicine and the use of remote and wearable devices,” commented Alistair Macdonald, ACRO Board Chair and CEO of Syneos Health. “As a result, patients have continued to have safe and effective access to investigational and potentially life-saving treatments.”
The Association of Clinical Research Organizations (ACRO) represents clinical research and technology companies that provide a variety of specialized services to support the development of new pharmaceuticals, biologics, and medical devices. Through its member companies, ACRO helps improve the quality, efficiency, and safety of biomedical research. ACRO member companies operate in more than 100 countries across the globe and conduct or support the conduct of the majority of clinical trials worldwide.