By: Bethel T.   March 22, 2024

“Trial processes should be operationally feasible and avoid unnecessary complexity, procedures and data collection. Trial processes should support the key trial objectives.” ICH-GCP E6R3 Section 9.3 (1)

Clinical trials are crucial for testing the safety and efficacy of new treatments and medical interventions. However, the complexity of trial processes can sometimes hinder their operational feasibility. To ensure streamlined and effective trial processes, it's important to avoid unnecessary complexity and procedures while ensuring that they support the key trial objectives. 

Understanding Operational Feasibility

Operational feasibility refers to the practicality of conducting a clinical trial within the available resources and constraints. This encompasses various aspects, including financial resources, human resources, time, and technology. Simplifying trial processes can significantly enhance operational feasibility by reducing the burden on these resources.

Streamlining Procedures

Complicated and burdensome procedures not only raise the cost and duration of conducting a trial but also discourage potential participants and result in data inaccuracies.

Therefore, it's essential to streamline procedures by:

• Simplifying Data Collection: Focusing on collecting essential data that directly aligns with the trial objectives can prevent the unnecessary burden of collecting excessive data.
• Minimizing Administrative Burden: Reducing administrative tasks for both trial organizers and participants can streamline the process and make it more efficient.
• Optimizing Participant Recruitment: Implementing straightforward and clear participant recruitment processes can enhance the efficiency of trial enrollment.

Supporting Key Trial Objectives

While simplifying trial processes, it's crucial to ensure that the streamlined procedures continue to support the key trial objectives, such as ensuring participant safety, collecting reliable data, and achieving meaningful outcomes. This can be achieved by:

• Prioritizing Safety Protocols: Simplification should not come at the cost of compromising participant safety. The trial processes must continue to uphold rigorous safety protocols.
• Emphasizing Data Quality: Despite simplification, measures should be in place to maintain the quality and integrity of the collected data, ensuring that it is robust and reliable.
• Focusing on Outcome Relevance: The streamlined procedures should closely match the intended goals of the trial, guaranteeing that the gathered data is relevant to the research objectives.

Embracing Technology

Advancements in technology offer opportunities to simplify trial processes significantly. Incorporating Electronic Data Capture Systems, Remote Monitoring Technologies and digital communication platforms (Messaging apps, Video Conferencing Platforms, Email Platforms, Social Media Platforms, etc.) can streamline data collection, enhance participant engagement, and reduce the administrative burden by automating tasks, enabling remote monitoring, and facilitating communication between researchers and participants.

Examples of these devices include:

Incorporating electronic data capture systems:

• Viedoc: Viedoc is an EDC platform designed to streamline data collection and enhance the efficiency of clinical research. It offers features such as seamless collaboration, real-time data access, and analysis capabilities.
• Medidata Rave: Medidata Rave is an advanced and secure EDC system known for its flexibility, adaptability to various study sizes, and real-time data validation and surveillance features. It also provides robust reporting and analysis tools for informed decision-making.
• Klindat: Klindat, developed by Zlynger, is a powerful and secure EDC system designed to simplify the collection, cleaning, and processing of data in clinical trials. It offers a user-friendly interface, accessibility through the Internet, and robust data management features.

Remote Monitoring Technologies:

• Blood Pressure Cuff: determines a patient’s heart rate and blood circulation by assessing variations in artery movement. The Bluetooth-enabled blood pressure cuff resembles the conventional device used in medical settings, with the crucial distinction of transmitting data instantly to the clinician for evaluation.
• Blood Glucose Meter: analyze a patient’s blood sugar levels using a tiny blood sample applied to a test strip linked to the device. The patient applies a small blood drop to the test strip, which is scanned by the meter to generate the blood glucose measurement. Subsequently, the measurement is transmitted instantaneously to the healthcare provider for assessment.
• Pulse Oximeter: is a non-invasive clip attached to the patient’s finger (or occasionally the earlobe) to measure light wavelengths that determine the blood oxygen level, indicating the oxygen saturation in the patient’s red blood cells. Additionally, the pulse oximeter records the patient’s pulse.

Enhancing operational feasibility and maximizing the efficiency of valuable research endeavors necessitate the simplification of trial processes. Through the strategic streamlining of procedures, alignment with key trial objectives, and wholehearted integration of technology, clinical trials can attain heightened accessibility, cost-effectiveness, and, consequently, greater impact in advancing medical knowledge and elevating patient care standards.

It's essential to underscore that the simplification of trial processes should not be misconstrued as sacrificing quality or rigor. Rather, it entails strategically optimizing the allocation of resources and refining procedures to ensure the attainment of optimal outcomes for all stakeholders engaged in the clinical trial process.

REFERENCE

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH Harmonised Guideline Good Clinical Practice (GCP) E6(R3), Section 9.3, https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf