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Given the wide use of digital technologies in society today, apprehension about implementing eCOA and creating an eCOA back-up plan is unwarranted.
Digital solutions have without a doubt improved both the quality and the quantity of data collected in clinical trials. The positive impact that eClinical Outcome Assessment (eCOA) has had on the success of clinical trials is no longer disputed 1, 2, 3, 4, and this is in addition to increasing preference among end-users for digital data reporting. The annual eCOA adoption growth rate has been reported to be 16%, yet less than 25% of all possible studies incorporate eCOA5, primarily due to misperceptions of the risk factors associated with implementing eCOA and eCOA backup solutions.Contrary to popular belief, e-devices are rarely damaged; they seldom need replacing. And unlike paper, the volume and quality of digital data collection are significantly higher, thereby adding value to the study. Given the wide use of digital technologies in society today, apprehension about implementing eCOA and creating an eCOA back-up plan is unwarranted. Rather, with the choice of eCOA back-up solutions now available, implementing an eCOA back-up plan that safeguards, as well as optimizing data collection, has become a streamlined process readily adaptable to the specifics of any project.
Even though cases where e-devices fail are quite rare, significantly limiting the overall risk of losing data, a robust back-up solution remains necessary. eCOA back-up solutions enable clinical sites and sponsors to guard against two types of potential electronic device failures: permanent failure (through theft or breakage); temporary failure (through a connectivity issue, forgotten password, or loose electrical cable, etc.).
It is important to approach an eCOA back-up solution as an integral part of the study design and not just as an ‘add-on’ to a clinical trial. Given the wide choice of electronic options now available, and in order to adhere to the recent recommendations from the competent authorities as well as the specialized organizations such as the C-Path Institute PRO and ePRO Consortiums, an efficient back-up solution should not be paper-based.
It has been well-documented that paper-based approaches result in untimely, unreadable, missing or often illogical data, all of which can have a very deleterious effect on data quality7, 8. It has also been strongly discouraged by the C-Path’s institute ePRO Consortium11to use paper as a back-up solution. “We strongly discourage the mixing of paper and electronic field-based instruments and suggest that mixing of only electronic modes be considered for clinical trials and only after equivalence has been established9.”
Selecting a well-adapted electronic back-up solution can be quite simple as long as it is anticipated and implemented with a well-coordinated project plan. It can be extensively supported by eCOA solution vendors and eCOA experts, and will also be facilitated by detailed review of the four existing options to characterize them and evaluate their advantages and drawbacks:
However, deployment of this type of solution does not come without the technical challenge of ensuring that the solution will work in a standard manner on different types of devices-should several patients request this solution. It could also increase the burden for the site’s staff, having to verify the upload of the application and access to the patient’s questionnaires or e-diaries. It can be a fair reason for a team opting out of this option.
There now seems to be sufficient eCOA backup solutions available for each clinical team to find a tailored plan that will satisfy the requirements for each project and therefore secure patient and clinical data collection.
An eCOA backup solution has to remain a temporary solution
It is important to note that back-up solutions should only be deployed in the specific circumstances. This is where the original designed solution cannot be used because of device failure, loss or impossibility of use, and is a temporary solution. The timeframe should be limited, and it should never replace the original solution.
Using a back-up solution-as an alternative data capture for a significant period of time-would lead to significant “mix mode” of patients’ data capture which may complicate the audit trails, lead to potential lack of comparability of the data and so may potentially jeopardize the validity of the clinical trial. The FDA states in their PRO Guidance, that they “intend to review the comparability of data obtained when using multiple data collection methods or administration modes within a single clinical trial to determine whether the treatment effect varies by methods or modes.”(FDA, 2009). Although technology makes mixed modes of data collection feasible operationally, clinical trial designs need to consider the sources of error variance in the PRO data, and only sufficiently tested PRO collection modes should be considered.
To implement the right eCOA back-up plan requires taking a few well thought through steps:
Apprehension about digital technologies seems unÂÂÂÂÂwarranted. Continued education of all parties, shared experience and learnings of clinical trial stakeholders, and reference to existing regulations and recommendations from the authorities do represent a strong avenue to support eCOA implementation and electronic back-up solution strategies.
Implementing a complete eCOA strategy, including an adapted backup solution, creates a way to support both the industry stakeholders in their collection of clinical data, and the patients and the sites who generously provide them.
Estelle Haenel, PhD is the Medical Director at Kayentis.