January 16, 2017News
On 4 January 2017, Applied Clinical Trials published an online paper, entitled, Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials. The paper is coauthored by Jonathan Helfgott, MS, former the Associate Director for Risk Science at FDA CDER OSI and the main author of FDA’s eSource Guidance, and Jules Mitchel, MBA, PhD, President, Target Health Inc. Jonathan is currently the Coordinator of the Regulatory Science Graduate Program at Johns Hopkins University.
The following are some excerpts from the paper which is meant to be both informative and evocative.
Introduction: The regulatory push to the paperless clinical trial has occurred despite a pharmaceutical industry that has been risk-averse in adopting modern-day technology tools that could support clinical trials. This risk aversion is in part due to fear by sites and sponsors of receiving a FDA Form 483. What if the FDA turns down an application if it discovers that, for example, a patient was born in 1982, when in the study database it is recorded as 1983, even when there is no impact on the study results? The clinical sites are also fearful of losing business as a result of any FDA Form 483 finding, however minor.
Risk Assessments: A quality by design (QbD) methodology, which includes a risk assessment and risk mitigation strategies, is a critical exercise when building software. Using a Boeing 787 analogy, a plane has several electrical systems that control the engine and the coffee machine. We should not assign the same risk to the coffee machine not delivering hot coffee as we do to the engine failing on takeoff.
Discussion and Conclusion: For more than a decade, technologies and processes allowing for the paperless clinical trial have been substantiated and encouraged from both the business and regulatory perspectives. The time is ripe to put away fears of regulatory sanctions when using modern technology, and make changes to modernize and optimize the drug and device development processes that will ultimately, positively, support the regulatory approval process.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.