Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
Synopsis
Always select the technology AFTER selecting the outcome
Questions To Ask
- Study Objectives and Endpoints:
- What are the primary and secondary objectives of your trial?
- What endpoints are you measuring, and how can technology help capture these endpoints more accurately or efficiently?
- Participant Needs and Engagement
- How can technology improve participant recruitment, retention, and engagement?
- Are there digital tools that can make participation easier, such as mobile apps for data entry or wearable devices for continuous monitoring?
- Data Collection and Management
- What types of data will you collect, and how can technology streamline this process?
- Consider electronic data capture (EDC) systems, remote monitoring tools, and data analytics platforms to manage and analyze data effectively.
- Regulatory Compliance and Validation:
- Is the technology compliant with regulatory requirements (e.g., FDA, EMA)?
- Has the technology been validated for accuracy, reliability, and security in the context of clinical trials?
- Operational Efficiency:
- How can technology improve the efficiency of trial operations, such as site management, patient monitoring, and data reporting?
- Look into clinical trial management systems (CTMS) and other tools that can automate and streamline trial processes.
- Cost and Resource Allocation:
- What is the cost of implementing the technology, and does it fit within your budget?
- Consider the resources needed for training, maintenance, and support of the technology.
- Scalability and Flexibility:
- Can the technology scale with the size and complexity of your trial?
- Is it flexible enough to adapt to changes in the trial design or protocol?
Why involve Tech, Device, and Data Companies now?
A clinical protocol synopsis is a blueprint for clinical trial planning that, when done right, can boost the efficiency of the process. Involving Tech, Device, and Data companies for the synopsis can help ensure the study is needed and feasible through a data-driven approach. As endpoints are being further defined, there are some important questions to ask when determining if technology can help support your study.
What aspects of the synopsis should they inform?
- Study rationale: Analyze patient characteristics and standards of care to determine and communicate gaps in treatment outcomes.
- Study population: Calculate the incidence and prevalence of the study indication and identify relevant clinical characteristics to consider in the protocol.
- Main Inclusion/Exclusion criteria: Identify and pressure-test the impact of key inclusion and exclusion criteria to evaluate the feasibility of a trial.
- Subject number: Utilize incidence and prevalence trends to inform the optimal and feasible number of trial participants.
- Risks: Identify clinically relevant comorbidities and risk factors that may jeopardize the safety of potential trial participants in the study population.
- Clinical sites: Conduct early intelligence of regions and sites with patients that meet the main protocol criteria and have resources needed for facilitating a trial.
Tech, Device, and Data Company Resources
A Smarter Approach to Clinical Trial Design and Delivery
Using digital technologies in clinical trials: current and future applications
Embracing Hybrid Trial Design - How, When, & Why To Use It
Artificial Intelligence for Clinical Trial Design
Clinical Trial Management Systems