Introduction
In light of evolving regulatory requirements, recruitment challenges, and external factors such as the COVID-19 pandemic, clinical trials are becoming increasingly dynamic, resulting in more frequent protocol amendments and interactive response technology (IRT) reprogramming.
A study by the Tufts Center for the Study of Drug Development published in 2024 found that over 75% of clinical trial protocols across Phases I-IV required at least one substantial amendment, with the average time to implement such an amendment nearly tripling over the last ten years.
For pharmaceutical companies and contract research organizations (CROs), this can lead to significant delays, increased costs, and operational inefficiencies which can completely derail pre-determined trial timelines.
Self-service capabilities in randomization and trial supply management (RTSM) systems offer a potential solution, empowering CROs by providing the flexibility to adapt seamlessly to the evolving nature of clinical trials.
The Challenge for CROs
CROs allow pharmaceutical companies to efficiently outsource clinical trials and research, providing specialized expertise, reducing costs, and accelerating time-to-market.
Amendments to research protocols make up a significant challenge for CROs, especially when a change in scope (CiS) is required. A clinical trial budget should include all trial conduct costs from the start, however, this is not always feasible over the long term, especially with global trials. A sponsor expects a good CRO to protect their budget, but there are often unplanned study costs associated with slower-than-expected enrolment and protocol amendments.
CROs need a solution that allows flexibility without ongoing renegotiation with clinical trial sponsors.
Clinical Trial Amendments
Amendments can be categorized as substantial or non-substantial, depending on the potential impact of the change on the trial’s conduct, participant safety, or data integrity. Implementing these amendments requires additional time and resources.
According to one mixed methods study on NHS UK Sponsored Research, “addition of sites” was the most common amendment implemented to achieve a clinical trial’s recruitment target. Other frequent examples of protocol amendments include additional geographical locations, investigators, or modifications to the study design or methodology.
Traditional RTSM solutions often require a change in scope for protocol amendments, leading to additional costs and delays. This is what makes an RTSM solution with self-service amendment capabilities so appealing.
‘Self-service’ means that research teams can make mid-study changes quickly and efficiently without interruption. This enhanced flexibility not only reduces costs and helps CROs stick to their pre-agreed study timelines but also enhances overall trial efficiency and responsiveness.
The Role of IRT in Managing Amendments
IRT solutions provide essential trial management capabilities, enabling real-time data access, participant randomization and resupply, and integration with existing systems. IRT systems with self-service capabilities often support various functions, including:
- User management
- Study management
- Country management
- Site management
- Shipment and inventory management
- Depot management
IRT Systems can also be configured to include additional capabilities, such as cohort management, adaptive trial support with design adaptions, and protocol amendment management, based on the needs of the study.
Perceptive eClinical, a leading global provider of technology-enabled services for clinical trials, explains how their self-service capabilities are empowering CROs:
“Our system puts the power into the hands of our study teams and users, with the ability to make real-time changes as needed.”
A well-designed IRT system ensures essential RTSM functions remain automated and efficient while providing research teams with the flexibility they need to make trial modifications.
How Self-Service Empowers CROs
IRT systems with self-service capabilities are empowering CROs, putting them in control to manage their studies effectively, even in the face of inevitable protocol amendments.
Self-service allows CROs to implement protocol modifications without requiring extensive reprogramming, vendor intervention, or changes in scope. By reducing reliance on reconfiguration or reprogramming, these systems help minimize delays and costs.
Finding an IRT system that provides the ability to make both common and protocol-specific self-service changes at no extra charge, reduces the need for budget renegotiation with sponsors and minimizes potential delays in the clinical trial process.
“Self-service capabilities in IRT give users the ability to make immediate changes as needed, from responding to recruitment delays to building flexibility for managing protocol amendments. The adaptable technology helps manage both planned and unexpected challenges, keeping trials on track,” says Beth Crawley, eClinical Product Director at Perceptive eClinical.
Perceptive eClinical solutions allow for the flexibility of your future trial needs. To find out more, go to: https://www.perceptive.com/eclinical-perceptive/home/
Resource
Therapeutic Innovation & Regulatory Science. (2024) New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance. https://pubmed.ncbi.nlm.nih.gov/38438658/
Trials. (Johi, 2023) Common Clinical Trial Amendments, why they are submitted and how they can be avoided: a mixed methods study on NHS UK Sponsored Research (Amendments Assemble). https://pmc.ncbi.nlm.nih.gov/articles/PMC9811046/
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