What is eCOA?

Understanding its power and significance in clinical trials

‍As clinical trials have become increasingly complex and data-driven, the need for more efficient and accurate data collection has become paramount. This has led to the development of electronic Clinical Outcome Assessments (eCOA), a technology that’s revolutionized data collection in clinical trials.

In this comprehensive guide, we’ll delve into the very essence of eCOA – its purpose, its mechanisms and its indispensable role in shaping the future of modern clinical trials.

Introduction to eCOA in clinical trials

By providing valuable data on the safety and efficacy of new drugs, medical devices and treatments. However, the reliance on traditional paper-based data collection methods has presented numerous hurdles, from cumbersome processes to potential inaccuracies. 

But by harnessing the power of electronic devices like smartphones, tablets, connected devices and computers, eCOA offers a transformative solution for collecting patient-reported outcomes (PROs) data. Its ability to enhance data quality, reduce errors and streamline processes has led to eCOA technology’s increased popularity among clinical trial sponsors.

What is eCOA, and how does it work?

PROs are crucial data collected directly from patients regarding their symptoms, quality of life and treatment preferences. To facilitate this, eCOA technology uses a variety of electronic devices like smartphones, tablets and computers to enable patients to conveniently complete questionnaires and surveys either at home or in the clinic.

eCOA technology uses a range of software and hardware components to capture and manage PROs. The software component includes the eCOA application, which is installed on the electronic device used for data collection. The hardware component includes the electronic device itself, such as a smartphone or tablet.

• ePRO: Patient Reported Outcomes. Patients report on their health via questionnaires or assessments.
• eClinRO: Clinician Reported Outcomes. Health outcomes are reported by a clinician.
• eObsRO: Observer Reported Outcomes. Completed by someone other than the patient or the clinician, such as a caregiver, based on events and behaviors observed.
• ePerfO: Performance Outcomes are measures from specific tasks the patient is asked to perform.

Specifically tailored for clinical trials, the eCOA application is designed to accurately capture PRO data. It offers a range of customizable assessments and diaries tailored to meet the specific requirements of each clinical trial. The application also includes built-in checks and validations to ensure data accuracy and completeness.

eCOA vs. Paper

eCOA offers more controlled, reliable and efficient data management compared to traditional paper-based methods. For example, when compared to paper-based assessments, eCOA eliminates inconsistent data, increases patient compliance, is preferred by patients and recommended by regulatory agencies.^1-4 With parameters and time windows set in advance, data entry errors are minimized. Real-time, automatic data transfer to a central database speeds up study timelines and facilitates immediate access to information throughout the study, thus enhancing patient safety.

eCOA’s Bring Your Own Device (BYOD) approach reduces costs, integrates seamlessly into patients’ daily lives, and is compatible with medical devices, connected devices, wearables, electronic data capture (EDC) and interactive voice response (IVR). This method promotes higher protocol compliance, a claim supported by a study showing that patients using eDiaries/ePRO have significantly higher protocol compliance (Stone A, et al. 2002. Patient non-compliance with paper diaries.).

Paper capture can lead to data errors and inefficiencies, including double data entry, QC checks and burdensome logistics. Its lack of real-time visibility can delay interventions for patient safety and negatively impact study performance. Paper capture also faces ethical and regulatory challenges due to its perceived burden on patients, resulting in lower compliance levels without electronic reminders. Furthermore, paper capture’s upfront cost can be deceiving. Hidden fees for manual entry and storage inflate the total price, often times higher than the cost of using eCOA.

When is it critical to use eCOA?

“There are several scenarios when it is critical to capture your endpoint data electronically rather than on paper.”

Valdo Arnera, M.D. – eCOA Scientific Advisor

These include:

• Questionnaires and/or daily diaries which are supporting primary endpoints: eCOA should be used when the success of your trial resides on the collection of patient diaries, as electronic assessments deliver significantly higher-quality data and more accurate results than paper data collection.
• Questionnaires that don’t support primary endpoints but are unsupervised: Without the supervision of a healthcare professional, patients may procrastinate, inaccurately record, or forget to record entries in their questionnaire. Electronic assessments are designed to minimize or eliminate these problems through:
  • Alarms that are programmed to remind patients to complete their questionnaires appropriately
  • Software that prevents back and forward filling
  • Real-time reporting that automatically alerts sites when patient compliance is below a set threshold, allowing sites to intervene when necessary.
• Monitoring for Suicidal Ideation and Behavior (SIB): Sites must know in real-time if a patient is experiencing suicidal thoughts. Electronic tools, such as the self-reported electronic Columbia Suicide Severity Rating Scale (eC-SSRS) or the interviewer-rated C-SSRS, can achieve this level of urgency. The patient-reported version of the C-SSRS provides increased patient honesty, reduces rater variability, and allows real-time suicide risk notification.
• Integrating data from another source: If patients inaccurately record or forget to record meter values from other devices like glucometers, eCOA features such as automatic data transfer and reminders offer an added layer of support.
• Complex ClinROs: Complex calculations and scoring are error-prone and can be eliminated with automatic calculations. An example here would be the Psoriasis Area Severity Index [PASI].
• Rare disease studies: These cases often have few participants in the study. It’s therefore essential to minimize missing and incomplete data.

When is it recommended to use eCOA?

To reduce burden and receive consistent, high-quality data, we also recommend using eCOA in the following scenarios:

• Oncology trials: Regulators recommend using eCOA in oncology trials⁵ and are now requesting additional information about drug efficacy beyond survival, such as quality of life (e.g., symptom relief).
• Large-scale studies: Errors incurred when using paper can result in significant delays and costs due to data cleansing and processing. This is especially true when working across diverse populations and in multiple countries.

eCOA vs. ePRO –  What’s the difference?

While eCOA and ePRO are often used interchangeably, it’s important to note the distinction between the two. ePRO is a subset of eCOA that specifically focuses on the collection of PRO data, and primarily used in studies where such data serves as the primary endpoint.

On the other hand, eCOA is the umbrella term that covers data collected electronically by a patient (ePRO), a clinician (eClinRO), observer such as a caregiver (eObsRO) or ePerfO where performances of tests are recorded.

The benefits of using eCOA in clinical trials

eCOA technology offers several benefits to clinical trial sponsors, including:

Improved data quality

eCOA technology includes built-in checks and validations to ensure data accuracy and completeness. This meticulous approach minimizes the risk of data errors, delivering more accurate outcome assessment data.

More efficient data collection

With the ability to complete questionnaires and surveys at home, sponsors can reduce the frequency of clinic visits. This not only enhances convenience for participants but may also translates into substantial cost savings for clinical trial sponsors.

Real-time data monitoring

The ability to monitor data in real-time facilitates timely corrective actions, enhancing the integrity and reliability of the collected information. Moreover, real-time data monitoring enables sponsors to identify noteworthy trends and patterns within the data, providing valuable insights for informed and fast decision-making throughout the trial process.

eCOA endpoint selection, data collection and reporting

eCOA data collection and management involve several steps, including:

1. Endpoint selection

A critical early stage, this involves identifying the most pertinent outcomes to measure in your trial. eCOA providers offer expertise and guidance in this process, ensuring that your chosen endpoints align with the trial’s objectives and are sensitive to potential changes or results.

2. Study design

This is the first step in eCOA data collection and management. The study design should include the selection of appropriate eCOA questionnaires and surveys and the specification of data collection schedules.

3. Device selection and configuration

The next step is device selection and configuration. The device used for data collection should be selected based on the specific requirements of the clinical trial. The device should also be configured to ensure optimal data collection.

4. Data collection

Next is data collection and management. Patients can complete assessments and diaries at home or in the clinic. The eCOA application includes built-in checks and validations to ensure data accuracy and completeness.

5. Data management

The critical last phase involves meticulous data management. eCOA data should be securely transferred to a central database for analysis. The data should also be cleaned, validated and analyzed to ensure data quality.

ePerfo and eClinRO – The future of eCOA

ePerfo (electronic Performance Outcome) and eClinRO (electronic Clinician-Reported Outcome) are two technologies poised to enhance the accuracy and efficiency of data collection in clinical trials. ePerfo introduces an innovative way to capture more accurate performance data, including gait speed and balance, through electronic devices, while eClinRO facilitates the collection of clinician-reported outcomes data using electronic devices. 

Researchers and clinicians will benefit from the invaluable insights derived from these advanced technologies, leading to more informed and effective approaches in healthcare and clinical research. 

eCOA in pharma – Where does it fit in?

eCOA technology has evolved into an indispensable tool within the pharmaceutical industry, finding widespread adoption in clinical trials. Its versatility allows for the collection of vital patient-reported outcomes data, adverse events, and other essential clinical trial information. By streamlining data collection processes, eCOA technology not only improves data quality but can also deliver cost savings for clinical trial sponsors.

Choosing the right eCOA solution for your clinical trial

Choosing the right eCOA solution for your clinical trial is essential. Several factors need to be considered when selecting an eCOA provider, such as:

Scientific expertise

The eCOA provider should be well-versed in diverse therapeutic areas and understand the scientific context of your study. Their expertise is instrumental in refining endpoint selection, enhancing study design and ensuring your trial adheres to the best scientific practices.

Experience

The eCOA provider should have experience in providing eCOA solutions for clinical trials and should have a proven track record of delivering high-quality services.

Operational experience

An eCOA provider should demonstrate a thorough understanding of global regulatory requirements, logistical complexities and the ability to manage large-scale trials. A provider with vast operational experience can better anticipate potential roadblocks and implement efficient solutions, ensuring the smooth conduct of your clinical trial.

Technology

The eCOA provider’s technology should be up-to-date, reliable and secure. The provider should be able to provide a range of electronic devices and software that can be customized to suit the specific requirements of the clinical trial.

Customer support

It’s imperative that the provider offers robust customer assistance, including prompt technical support and comprehensive training. Moreover, the provider should be highly responsive to customer queries and concerns, ensuring a smooth and satisfying experience for their clients.

The importance of eCOA in modern clinical trials

With its ability to streamline process, eCOA enables more efficient and accurate data collection, while also facilitating real-time data monitoring. This transformative technology has swiftly become an indispensable component of the pharmaceutical industry, increasingly recognized as a standard practice in clinical trials.

eCOA providers offer a diverse array of solutions that can be tailored to meet the unique requirements of each clinical trial. Choosing the right eCOA solution is paramount to ensuring the success and effectiveness of the trial. Moreover, the future of eCOA looks promising, as clinical outcome assessments like ePerfo advance the field even further.

References

¹ Food and Drug Administration, FDA. 2009. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.
² Food and Drug Administration, FDA. 2010. Guidance for Industry: Electronic Source Documentation in Clinical Investigations.
³ EMEA, 2005. Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products.
⁴ EMA 2014, Reflection Paper on the use of patient reported outcome 5 (PRO) measures in oncology studies
⁵ Food and Drug Administration, FDA. 2018. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, Guidance for Industry