Clinical trials are getting ever more complex. Study designs are becoming more sophisticated and outcome assessments require more diverse data, thus resulting in larger datasets.
The adoption of cloud-based clinical trial software as an industry standard has significantly streamlined these operations, including the start-up of multicentred and multinational clinical trials. Metadata standardization and advanced automatic data cleaning features have also contributed to reductions in the overall clinical trial timelines. However, available Randomization and Trial Supply Management (RTSM) solutions have yet to provide the desired levels of process automatization. This is especially true in the case of clinical trial randomization and subject allocation to treatment.
The Essentials of Randomization and Treatment Allocation
Randomization in clinical trials is the procedure of randomly assigning subjects to treatment arms or groups. Treatment allocation is the process of assigning a specific treatment, investigational product, or intervention to subjects.
Randomization and treatment allocation are the bedrock of modern clinical trials, as they ensure reliable trial results by minimizing bias and maintaining balance between treatment arms. Additionally, they must ensure that trial subjects receive the appropriate treatment as defined by the study protocol.
Today, randomization and treatment allocation procedures are increasingly performed within Randomization and Trial Supply (RTSM) software solutions. These solutions are very helpful in clinical trial operations, as they reduce the need for manual labour, decrease error rates, while enabling automation, and more efficient process management through real-time metrics. However, some issues still remain.
RTSM – eCRF Integration: The Current State of Affairs
With today's information technology advancements, seamlessly integrating RTSM functionality with an electronic Case Report Form (eCRF) should be straightforward and should be the industry standard. Unfortunately, this is not the case.
Most clinical trials either do not take advantage of advanced software or use disparate or loosely coupled RTSM and EDC systems. Either way, this results in increased costs and burdens on already strained human resources.
A few systems have integrated randomization and treatment allocation with eCRF functionalities; however, notable operational issues remain. These systems have eCRF and RTSM modules on a single platform, but users cannot perform randomization within the eCRF, they can only request it from an external module. This involves an additional step in the process, requiring another professional, such as a data manager, to separately perform randomization and treatment allocation. Although integrated, these software solutions have failed to deliver a fully automated process and the benefits promised to clinical trial professionals. As with all procedures that require additional steps - especially ones with human intervention - errors are inevitable.
Is it possible to deliver a more efficient process that streamlines operations while drastically reducing human error?
A Completely Integrated RTSM-eCRF Solution
By combining clinical trial and clinical software development expertise, we at Wemedoo have produced a fully integrated and automated RTSM and eCRF nested within our Oomnia Clinical Trial Suite (CTS).
Our unique framework follows pre-existing trial processes and business rules, thus complimenting physical steps while automating, simplifying, and reducing site errors as much as possible.
The randomization process is embedded within the RTSM, and it enables randomization according to any randomization scheme while automatically taking into account any stratification called for by the protocol. This is performed by seamless automatic communication between the eCRF and the RTSM module. Data entered in the eCRF is used to automatically detect whether the subject can be randomized to their assignment strata. We have synchronized randomization and stratification with on-site trial supply availability and created dynamic real-time treatment allocation within the eCRF itself. The end result is that the user can perform randomization and allocation to treatment with one single click within the eCRF. There is no need for additional staff and trial requests as the unified system performs all processes automatically without any human intervention.
We have not only removed sources of potential bias but have extended this protection to treatment allocation by the sites. Additionally, we have enabled real-time business intelligence and process metrics which coherently cover both randomization and treatment allocation processes for maximum performance and operational effectiveness.
The Oomnia Clinical Trial Suite offers a variety of benefits to stakeholders, including:
- Randomization list generation
- A variety of predefined randomization schemes (simple, blocks, random permuted blocks, other)
- Unlimited custom defined stratification (by age, sex, site, or any CRF variable)
- Unlimited treatment groups
- Custom allocation ratios
- User e-mail notifications
- In-system notifications
- Secure unblinding procedures
- Real-time business intelligence and process metrics
An ideal randomization approach is one that ensures that the study can achieve the planned per protocol objectives. The randomization method must be chosen carefully by highly trained and experienced staff. It has a decisive impact on the interpretation, credibility, and even validity of the trial results.
When looking for the optimal solution, keep the following aspects in mind:
- Study design – parallel group design, crossover design, or factorial design
- Monocentric and multicentric trials
- Type of comparison - trials to show superiority, trials to show equivalence or non-inferiority, trials to show dose-response relationship
- Group sequential designs
- Sample size
- Trial supply and suppliers
- Data capture and processing
Contact us for a free demo and to see how the combination of our Wemedoo clinical trial experts and Oomnia Clinical Trail Suite can help you succeed.
ICH Official Web site [Internet cited: March 03, 2022] Available from:
National Center for Biotechnology Information [Internet cited: March 02, 2022] Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3111167/
Biomedcentral [Internet cited: February 28, 2022] Available from: https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-021-01303-z
National Cancer Institute [Internet cited: February 27, 2022] Available from: https://ctrandomization.cancer.gov/about/