Although thousands of clinical trials begin each year, “R&D productivity remains stubbornly low,” write Gaurav Agrawal and fellow researchers at McKinsey. Even with R&D spending up from 44 percent over the decade to 2022, the number of U.S. novel drug approvals has stayed flat. In the face of this challenge, clinical trial managers seek ways to improve efficiency and streamline clinical trial operations.
Below, we examine the operational challenges clinical trial managers face. We explore how integrated technology solutions, such as those offered by Anju’s TrialMaster, can help address these issues to drive efficiency without sacrificing clinical operations quality.
Key Factors Driving Up Clinical Operations Costs
The length of a clinical trial is directly related to its cost. “Rapid clinical trial execution shortens the clinical trial period, which is an important factor in clinical trial success,” write Eungdo Kim and fellow researchers in a 2023 study in Therapeutic Innovation & Regulatory Science.
Kim et al. identified several factors that affect the success of new drug clinical trials. Among the four factors named is clinical trial speed. The researchers found that a clinical trial’s speed and cost are related: The longer the trial goes on, the more costly it becomes. Factors that can slow down a clinical trial and thus increase costs include:
- Choosing clinical trial partners without regard to rapid clinical trial progress.
- Patient recruitment periods that drag on, often due to inefficiencies in the process.
- Clinical trial sites that choose not to randomize patient cohorts in early phase trials.
Research sites also struggle to manage costs or perform efficiently when they lack sufficient infrastructure. Close collaboration between the sponsor and researcher, and the use of a “coordinating center” for managing information, help reduce these costs and save time.
Digital Solutions for Streamlining Clinical Trial Operations
Anju’s TrialMaster allows clinical research teams to collect, process, and submit clinical trial data in a single, streamlined digital solution. TrialMaster supports phase I-IV clinical trials of all sizes, offering:
- Fast study builds. Clinical research teams can use TrialMaster’s intuitive interface to build flexible, simple, or complex studies for phase I-IV clinical trials. Build a study from scratch with TrialMaster’s WYSIWYG editor or access a library of templates and adapt them for your trial needs.
- Seamless integration with other systems. TrialMaster integrates seamlessly with other Anju offerings. It also offers robust export capabilities and APIs, allowing TrialMaster to communicate with other systems as needed for information exchange.
- Support for central labs. Upload lab data to TrialMaster easily. The tool’s TrialBuilder function allows researchers to define lab test ranges and controlling variables. With this information, TrialMaster can review and flag lab values that are out of range, making it easy for researchers to spot and respond to variances.
- Risk-based quality management. TrialMaster supports taking a Risk-Based Monitoring approach which reduces the amount of Source Data Verification. Patients can be randomized to a particular monitoring level with the randomization balance controlled by a site risk rating. The chosen monitoring level then determines which forms require SDV. If necessary, the monitoring level can be manually overridden to provide a higher or lower level of SDV for that patient.
- User-friendly, intuitive interfaces. From built-in eLearning functionality to guided data entry and an intuitive interface, TrialMaster helps clinical research teams familiarize themselves with its digital environment quickly. Users can learn as they work, allowing them to complete tasks without having to pause to learn their way around TrialMaster first.
By maintaining a single source of truth, TrialMaster helps clinical trial teams collaborate, meet regulatory requirements, and streamline clinical trial operations to save time and lower costs.
Why Clinical Trial Teams Need Integrated Digital Solutions
Clinical trial setup and execution still finds itself beset with inefficiencies and challenges. For example, inefficient patient recruitment remains a major challenge for clinical trial teams.
In a survey of principal investigators, Betina Idnay and fellow researchers found that the most commonly-used patient recruitment strategies were also the least time- or cost-efficient. In-person recruitment and manual review of patients’ medical records and intake evaluation required considerable time and effort, yet they were preferred over other means of managing patient recruitment by most studies.
Integrated digital solutions allow clinical research teams to change these inefficient, costly habits. Within a single, intuitive digital environment, clinical trial teams can build studies quickly without having to reinvent commonly-used documents, forms, or instructions. Teams can also access other necessary information, such as that related to patient recruitment, when the system integrates seamlessly with other information sources.
During a clinical trial, support for labs and risk management helps clinical trial teams avoid long periods of manual data input or review and respond to challenges more quickly — saving money by boosting efficiency within the trial process itself.
Finally, an integrated digital solution with an intuitive eLearning interface helps clinical trial teams get to work right away. Tools like Anju’s TrialMaster help clinical researchers finish tasks, without time spent on a lengthy orientation first.
Integrated technology solutions can address some of the largest inefficiencies in clinical research today, speeding up clinical trials and saving money while also helping researchers produce more thorough, accurate results.
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Authored by Laura Acosta, VP of Product Management, eClinical Division
Laura Acosta, VP of Product Management for Anju’s eClinical Division, brings over 25 years of experience in life sciences software, including significant roles at Oracle Health Sciences. With academic credentials from Boston University and Tufts University in Computer Science, Laura excels in navigating the complexities of eClinical solutions. Her commitment to continuous learning and innovation has earned her recognition as a trusted leader in the field. Connect with Laura on LinkedIn to explore her expertise further.