Why you need an eCOA strategy
17 Aug 2023
7 mins
Decentralized trials, also known as virtual clinical trials, revolutionize the field of clinical research by integrating technology to simplify the trial process and enhance patient engagement. Unlike traditional trials, virtual trials heavily rely on digital platforms, enabling patients to participate from the comfort of their homes or other remote locations without physical visits to clinical sites.
A crucial element of virtual clinical trials involves the utilization of electronic Clinical Outcome Assessments (eCOAs) to electronically collect patient-reported outcomes (PROs). Recognizing the immense potential of eCOAs in virtual trials, the US Food and Drug Administration (FDA) has formulated an eCOA strategy to guide their implementation in clinical research. The FDA emphasizes the importance of ensuring that eCOAs are scientifically valid, reliable, and relevant to the specific study population. Furthermore, the FDA encourages the development and adoption of patient-centric eCOAs, which prioritize the needs of patients by being user-friendly, comprehensible, and easy to complete.
What is an electronic Clinical Outcome Assessment?
An electronic Clinical Outcome Assessment (eCOA) is a method of collecting patient-reported outcomes (PROs) typically through the use of a digital device such as a computer, smartphone, or tablet. eCOAs are designed to capture data directly from patients in a standardized and systematic way, using validated questionnaires or surveys.
eCOAs have become increasingly popular in clinical trials, as they can provide a more accurate and complete picture of a patient's experience of a disease or condition. Traditional paper-based methods of collecting PROs are often subject to human errors and missing data, whereas eCOAs can provide immediate feedback to patients and can be programmed to prevent missing data or inconsistent responses.
Furthermore, traditional clinical outcome assessments (COAs) are often completed by healthcare providers or clinical staff and may not accurately reflect the patient experience. However, eCOAs are more patient-centric and provide patients with a voice in the research process, thus enabling researchers to gain more understanding of the true patient experience and ultimately improve healthcare outcomes.
What are the benefits of a patient-centric eCOA strategy?
A patient-centric eCOA strategy has several benefits for patients, researchers, and regulatory agencies, such as:
- Increased patient engagement: With eCOAs, patients can directly input their health data and communicate with their healthcare providers, improving real-time visibility. Providing patients with more control over their healthcare, enabling timely and accurate reporting of symptoms, and capturing patient-reported outcomes that are meaningful to patients increase patient satisfaction and engagement as well.
- Enhanced data quality: eCOAs have direct transmission of data into an electronic database, real-time data recording, time and date stamp capabilities, and the ability to program daily reminders. This results in standardized and accurate data, and elimination of transcription errors, ensuring that the data collected is of high quality.
- Improved efficiency: eCOAs can streamline the data collection process, reducing the time required for data entry and reducing the burden on clinicians. This can free up time and resources to focus on patient care.
- Cost-effective: eCOAs can be more cost-effective than traditional paper-based methods, as they reduce the need for manual data entry and storage. Additionally, eCOAs can improve the efficiency of clinical trials, potentially reducing costs and accelerating drug development.
A patient-centric eCOA strategy can ultimately lead to the development of safer and more effective treatments for patients. By establishing a framework for collecting and using eCOA data, the FDA can ensure that these assessments are scientifically valid and useful for regulatory decision-making.
What is the eCOA strategy proposed by FDA?
The FDA recommends that eCOAs, like all COAs, should provide reliable measurements of a patient's symptoms and be tailored to the specific purpose of the study. Trial sponsors should seek FDA feedback on their COA strategy early on in the development process for any type of eCOA. FDA highlights the five types of eCOA systems available: interactive voice responses, web-based platforms, mobile applications, digital pens, and tablets.
The FDA's eCOA guidance strategy covers several key areas when determining the suitability of each eCOA subtype. The key points of FDA’s strategy are highlighted below:
- Electronic data capture systems: FDA recommends the use of electronic data capture systems that meet certain criteria, such as being capable of collecting data directly from patients, ensuring the accuracy of the data, and providing adequate security and privacy protection. Electronic devices with alarm functions and daily reminders to capture electronic data, along with external alarm method, reduce missing data and automatically records important information like timestamps. If using electronic devices, it is also recommended to have a backup plan in case of malfunctions. Furthermore, when using subject-provided devices, sponsors should use a single platform to minimize variation, and provide a detailed plan for FDA review.
- Instrument development and validation: The FDA states that eCOAs must undergo the same rigorous development and validation processes as traditional paper-based instruments to ensure proper device and program functionality in clinical trials. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force outlines the necessary components of this process. Sponsors should perform usability testing, including patient cognitive interviews, after user acceptance testing (UAT) to ensure device functionality, questionnaire comprehension, and ease of use in the patient population, thereby minimizing the risk of poor-quality data.
- Training and education: The guidance emphasizes the importance of training and educating patients, clinicians, and study personnel on the proper use of eCOAs to ensure accurate data collection. Training should include an explanation of the purpose and benefits of eCOAs, instructions on how to use the devices or platforms, and guidance on how to troubleshoot any issues that may arise.
- Regulatory considerations: It is imperative that sponsors and investigators ensure that FDA regulatory requirements are met for record keeping, maintenance, and access. Source data control should be maintained by the clinical investigator(s) to ensure data integrity. eCOA data should also be compliant with all FDA regulatory guidelines as well as the International Conference on Harmonization’s (ICH) Guideline for Good Clinical Practice.
The nuances of eCOA translation
Patient-centered eCOAs are centered around capturing the patient's perspective. To ensure that patient's voices are accurately heard, it is crucial to utilize materials that are transparent, unambiguous, and easy to understand. There are certain challenges and considerations involved in translating patient-reported outcome (PRO) measures, such as questionnaires or surveys, from one language to another for use in international clinical trials. It is important for eCOAs to have linguistic validation, which is a critical step in ensuring that the data collected from eCOAs is valid and reliable across different languages and cultures. The use of electronic devices for data collection also requires careful consideration of the device's language settings and user interface to ensure that it is accessible and usable by all participants.
How RWS helps combat eCOA nuances
RWS's Linguistic Validation services can help combat the eCOA nuances by ensuring that patient-reported outcomes (PROs) are accurately translated and culturally adapted for use in global clinical trials. Linguistic validation is a critical step in developing eCOA instruments. It involves adapting instruments for use in different languages and cultures while maintaining their conceptual equivalence and ensuring the translated versions have similar measurement properties to the original versions.
RWS's linguistic validation process includes a thorough analysis of the source instrument, reviewing relevant literature, cultural adaptation, cognitive debriefing interviews, and documentation of the linguistic validation process. RWS’s linguistic validation process is based on the FDA’s proposed strategy and the recommendations provided by The International Society for Pharmacoeconomics and Outcomes Research Good Practice.
Using RWS's linguistic validation service enables trial sponsors to ensure that their eCOA instruments are accurately translated and culturally adapted to maintain their measurement properties in different languages and cultures. This can help to reduce the risk of data integrity issues, regulatory rejections, and increase the chances of regulatory approval for global clinical trials.
Wendy Farrell
All from Wendy FarrellRelated Articles
