Sponsors are increasingly turning to electronic solutions in order to solve the operational challenges that are faced when implementing clinical trials. One of the fastest growing solutions focuses on the implementation of electronic clinical outcome assessments (eCOAs) to help collect trial data. This article will walk through some of the primary operational barriers facing any organization when considering the use of eCOAs in a clinical trial setting. We’ll also discuss how to overcome those barriers to ensure that the eCOA system brings value and reliability to a study.
eCOA Operational Barriers
Understanding and defining an operational barrier is the first step in process. The following list of barriers is by no means a comprehensive one. This overview focuses on the key questions and challenges that should be considered and overcome to help implementation succeed:
- Timeline Concerns for eCOA Development: Is there an adequate lead time for thorough eCOA solutions design? Do the vendor timelines align with the study timelines? Starting a project too soon risks building an obsolete system, whereas starting a project too late, may delay the first subject’s ability to participate. The timeline for electronic COA development is often perceived as being longer than for paper COA set up.
- Cost/Funding Required to Implement eCOA: eCOA costs appear high compared to paper implementation, often ranging into the millions up-front for eCOA development for larger, complex studies. There are also additional costs associated with developing and validating new instruments for use in a trial. Is there enough study funding up front to implement eCOA?
- Lack of Sponsor Knowledge and Experience with eCOA: The lack of an internal subject matter expert (SME) may prevent a sponsor from using eCOA. Is there an eCOA SME available to support a specific study team? Does the study team have previous eCOA experience? Have there been previous negative experiences (perceived or real) with eCOA on a prior study? Understanding the full range of technology systems used in a clinical trial, can be extremely challenging for smaller study teams to manage.
- Burden to Site Staff and Subjects: Understanding the site feasibility and familiarity with eCOA is a key consideration. Will subjects be receptive to using an eCOA device or will it become a burden? Particular considerations such as potential physical, religious, or age limitations may prevent eCOA usage in certain subject populations.
- Training Concerns for Sites and Subjects: Will the sites and subjects receive the proper amount of training so that they are able to adopt the eCOA system and succeed in its use? Are there sufficient re-training methods in place for both sites and subjects if issues arise? Does the eCOA vendor have an efficient and knowledgeable help desk to troubleshoot with sites, subjects, and monitors if issues arise?
- Data Integrity and Device Failures: Introducing an eCOA device comes with potential hardware and software issues associated with the following items: battery concerns and charging materials; potential password creation and re-setting issues, date stamp issues may arise; device replacements may not be received in a timely fashion by subjects and key data points could be missed; transmission problems can occur due to poor network connections; key integrations with additional clinical systems may disrupt the study workflow; hardware failure concerns (cracked screen, broken buttons, frozen screen). The data captured by an eCOA device may still be incorrect even if the device is working properly due to incorrect study design or missed requirements. There will always be the potential for missing data and every effort should be taken to minimize this risk.
Overcoming Operational Barriers
Overcoming the operational barriers listed above, is imperative to the successful development and implementation of an eCOA system for use in a clinical trial. Following the subsequent guidelines and considerations, will greatly improve the likelihood of a successful eCOA solution.
- Timeline Concerns for eCOA Development: eCOA implementation timelines are in line with other eClinical systems such as Interactive Response Technology system (IRT) and Electronic Data Capture systems (EDC). Plan early with the selected eCOA vendor to communicate timelines, discuss key deliverables and expectations, and work to identify risks early on so they can be minimized and avoided. Ensure enough time is planned for assessment licensing, migration (if needed), linguistic validation, and any required translations of the eCOA system.
- Cost/Funding Required to Implement eCOA: Understanding the true cost of eCOA requires the consideration of the alternative option, paper collection. Collecting outcome assessments via paper has substantial costs including:
- The paper diary design
- The printing, shipping and storage of the paper
- Additional monitoring time by the CRO
- The physical collection of the paper diary
- Database development and transcription process
- Query resolution process and data cleansing
- Storage and archiving of the paper source documents
The cost of missing or incomplete data as a result of a paper diary is hard to quantify, but must be taken into consideration. Invariably, using eCOA will not only save time and money, it will provide higher-quality data and true compliance that can be remotely tracked via an audit trail.
- Lack of Sponsor Knowledge and Experience with eCOA: Conduct surveys and interviews within your organization to better understand the current eCOA experience levels and comfort. Work with eCOA vendors to gather costing models and perform vendor refresh where possible to build awareness across functions. Aligning with management inside a sponsor organization to promote the benefits of eCOA, will help build knowledge levels and result in a better understanding overall of what eCOA is and what it can do.
- Burden to Site Staff and Subjects: Negative attitudes toward eCOA among clinical staff are often associated with previous experiences with device failure, software issues, or vendor difficulties. Successful eCOA vendors are eager and committed to overcoming previous site staff issues by providing better and more stable devices, stronger technology/software, and a better process for resolving issues. It is imperative to engage with sites and subject to understand their needs. Ensuring there is sufficient training available to clinician staff and subjects will build their comfort and confidence in using the eCOA system. The end user must not be overlooked when building the eCOA system.
- Training Concerns for Sites and Subjects: Hands on training for site staff of any eCOA system is directly linked to a more successful use of eCOA in a study. Ensuring that site staff have the opportunity to physically practice on eCOA devices at an investigator meeting or at a site initiation visit, will help build their confidence. Successful training must go beyond just the hands on portion, however, it needs to include easily digestible and accessible re-training tools such as vendor training documents, on-line eLearning modules, or a videos or slide decks from the investigator meeting that were used to introduce the eCOA system. An additional key component to overcoming training concerns is a knowledgeable help desk that is staffed by eCOA vendor employees who can troubleshoot with site staff, subjects and monitors. Often times, the help desk is the front line of communication between the sites or subjects and the eCOA vendor. It is therefore vastly important to make sure the proper guidance is in place for the help desk to dispense.
- Data Integrity and Device Failures: An eCOA system maintains the standard for the quality of data collected in a clinical trial that is suitable for regulatory submissions which have been defined by the FDA to include the following 5 criteria: attributable, legible, contemporaneous, original and accurate (abbreviated by the acronym ALCOA). eCOA vendors are also bound by 21 Code of Federal Regulators, Part 11 which requires that audit trails, user IDs and passwords, to name a few items, are in place when building an eCOA system. Data that is collected via eCOA also has the benefit of a date and time stamp that helps sponsors and monitors maintain and track compliance within a particular study. Device failures are much less common given the new technology and devices that are used by current eCOA vendors. In the event of a device failure, it is always recommended that every site have spare devices on hand or in a particular country to allow for speedy and efficient device replacement, as needed.
In conclusion, it’s important to remember that like all electronic solutions, eCOA is a tremendous option with significant benefits to offer. Understanding how to utilize eCOA to its full potential will allow for higher-quality data collection, can save considerable time over the life of a trial, and can provide standard assessment workflows and software driven parameters. It can also help drive compliance across all subjects, save money in helping avoid missing data and potential transcription errors, as well as monitor delays from paper data collection. Ultimately, all of these considerations around eCOA can lead to stronger submissions and earlier trial completion, which offers a significant competitive business advantage to those willing to implement eCOA instead of paper.
Lead IRT & ePRO Operations Specialist
Note: The views and opinions expressed in this article are solely those of my own and are not necessarily those of Shire.
Information in this article is drawn from: “Barriers to Adoption of Electronic Collection of COA-based Endpoint Data in Clinical Trials.” Eighth Annual Patient-Reported Outcome Consortium Workshop. Workshop conducted on 26-27 April 2017, Bethesda MD by the Critical Path Institute. Link here.
 Food and Drug Administration, FDA. 2010. Guidance for Industry: Electronic Source Documentation in Clinical Investigations.