Clinical trials are the backbone of medical research, paving the way for innovative treatments and therapies. Yet, they often encounter delays, errors, and inefficiencies.
Enter Behavior-Driven Development (BDD) — a method poised to revolutionize the process and outcomes of clinical trials. This structured, collaborative software development approach translates seamlessly to clinical trial settings.
This article examines how BDD can enhance the efficiency, transparency, and reliability of clinical trials and the software platforms that support them.
Understanding Behavior-Driven Development
BDD is a process that focuses on a system or software’s behavior. It emphasizes collaboration between stakeholders, including developers, testers, and end-users. It encourages the creation of executable specifications that clarify and formalize a system’s expected behavior through concrete examples.
These examples, often written in a plain language called Gherkin, serve as living documentation and can be automatically tested. Applying BDD principles to eClinical trial platforms can be transformative, ensuring that everyone involved clearly understands the platform’s objectives and expected outcomes.
The Impact on Clinical Trials
Enhanced Clarity and Collaboration
BDD encourages the use of plain language to describe the behavior of a system. In clinical trials, this means that investigators, clinicians, regulatory bodies, software teams, and other stakeholders can co-create simple and concise specifications that leave no room for ambiguity. This clarity is essential to ensure that the trial’s goals, criteria for success, and desired outcomes are well-understood and consistently communicated.
Enhanced Testability
BDD scenarios are designed to be testable, meaning that they can be used as automated tests. This is particularly advantageous in eClinical trial software, where the evaluation of treatments and data collection must be precise and reproducible. Further, automated tests can help in systematically validating whether a trial and the software systems that power it are meeting requirements and adhering to established protocols.
Iterative Development and Adaptation
Promoting an iterative approach to development, BDD allows for adjustments and refinements as needed. In clinical trials, this means that if interim results or safety concerns arise, the trial can be adjusted promptly without jeopardizing its integrity. The ability to adapt and refine the trial protocol can save time and resources while ensuring that the research remains responsive to emerging findings.
Transparency and Accountability
BDD inherently creates a transparent and accountable environment. The clear, documented specifications and automated tests prevent errors or deviations from the trial’s protocol or software systems. This reduces the risk of data manipulation, misconduct or miscommunication while bolstering the credibility of the trial’s findings.
Continuous Documentation
Leveraging BDD, living documentation evolves in tandem with the trial. This means that any changes, updates, or amendments to the trial protocol are immediately captured in the documentation. Investigators and regulatory bodies benefit from up-to-date, accurate information, reducing misinterpretations.
Effective Training and Onboarding
Providing easy-to-understand trial specifications through BDD supports the onboarding of new team members. This alignment of all stakeholders minimizes errors and miscommunication, a critical factor in clinical trials.
The Next Generation of Clinical Trials
BDD can transform the efficacy of medical research by providing a structured, collaborative, and testable approach for clinical trials. It boosts transparency, accountability, and adaptability, making trial objectives and outcomes clear while reducing errors and delays. As the medical field evolves, integrating BDD into clinical trials can expedite the development of treatments and therapies, benefiting patients and society.
BDD is applied across all aspects of the trial, from core platform requirements to protocol customizations, providing assurance that studies align with intentions and accelerating deployments.
An early adopter of BDD, Alethium Health has leveraged its power for over a decade to deliver exceptional software faster, at lower costs, and with less risk.
Discover how Alethium’s expertise in BDD can revolutionize your next clinical trial. Schedule a demo today!
