De-risking bleeding edge DCT in Clinical Research

Doug Bain, Chief Technology Officer at KCR

Many of us that work in the field of clinical research wish to see improvements in how we carry out clinical trials and develop new and improved therapies. In order to make these improvements, we need to innovate.

One of the major challenges that software developers face is how to manage what is often referred to as being on the ‘bleeding edge’ of innovation.

As a consumer of software solutions that support clinical trials, we do not wish to place any of our patients or research in a position of compromise due to the application of new technology that is not yet sufficiently safe or effective.

The following article is aimed towards both up and coming vendors as well as consumers on what to do, what to avoid and how to deal with potential risks.

Risk Management

A used and abused term that may initially appear to be in conflict with innovation. However, I feel very strongly that one of the key elements to running an innovation project especially in a clinical trial setting, is the development and maintenance of a risk management plan.

Innovation is about learning lessons and improving. Clinical trials are not often a good setting for making mistakes and learning lessons.

If I look back at the 6 software vendors that I have worked at over the last 25 years I would say that better early risk management would have made a significant difference in dealing with the impact of change when problems arise. Problems occur, and in a clinical trial, if the problem manifests, then steps should be pre-prepared that maintain the integrity of the research.

For example, if a fault in a DCT solution impacts patients data or their involvement in a trial, a plan that defines for each type of fault, the steps to then apply to work around the impact of the fault should be pre-prepared — and ideally tested. Below are some typical examples;

  • Patients mobile device fails or is stolen
  • The device is not prompting the patient to enter responses as expected
  • The patient cannot login

Fix solutions should reflect the time urgency — for example, if a patient is asked to complete a diary in the evening, and they cannot login to the app — is support available at that time to complete their required action?

Independent consulting

Consultants that are experienced in the particular Therapeutic area, operational methods and/or technology that are ideally independent from any vendor can help ensure a balance position is defined and maintained through the life of the study.

A new vendor might have financial demands. They may ‘want’ a project to be successful, but it is an independent operational consultant that is often in the best position to assess, measure and report on whether a project is at risk and whether pre-emptive actions are necessary to avoid failure. These consultants may be from an independent consulting agency or from within a CRO like KCR.

Be the patient

This applies to any study that involves providing technology to the patient directly — so Decentralized Clinical Trials or ePRO studies.

Never ever start a study without running through the entire lifecycle of the study as the patient with the procedures, training and technology.

Technologists can have a rosy eyed image of the perfect patient, perfect site and simplified environment that does not match reality. Taking the overall ‘solution’ through from A-Z as if it was running for a real patient can uncover issues that might otherwise place the live study at jeopardy later.

Functional Vendor Assessment

In the clinical trial tech space, we often face a situation of having to choose between vendors that have clunky old products — but experience to work around their functional limitations versus new vendors that have wizz bang features, but lack the experience to handle the typical what-if scenarios.

These often young, highly funded vendors are often able to tick the quality and regulatory boxes — as a result they are capable of passing QA audits — however, their inexperience means they are not be in a position to respond with sufficient urgency when issues occur during a study.

An example is with ePRO compliance management. I recall a study that I previously implemented that had very specific time sensitive demands on daily diary completion. This was part of a complex protocol with multiple time windows during a day that differed from patient to patient. In this particular study, the site was responsible for monitoring patient ePRO compliance with the aid of comprehensive ‘push’ reminder management. This was all good and implemented to plan.

During a ‘be the patient’ test run, it became clear that without a realtime compliance dashboard it would not be viable for the sites to adequately monitor and action compliance management. This would mean that a significant number of volunteers could fall out of compliance resulting in potentially non viable data sets for analysis.

The solution was to provide an electronic daily compliance grid that displayed, through colour coding, the state of compliance for each separate diary by patient. The availability of the tool to the site was the difference between study success and failure.

Behind the scenes a fully integrated ePRO / EDC platform and database with realtime reportable data was the enabler for this compliance management grid view.

Computer Systems Validation

This is closely linked to the ‘Be the Patient’ approach. The completed implementation must be jointly tested and validated. Vendors are required to validate their system. However, the vendor validation only goes so far. This may only scope as far as ‘product’ validation. According to GAMP V standards, both Configuration Test and User Acceptance Testing should also be carried out. I wrote previously on how we implemented an electronic GAMP V based validation process at KCR. Well executed end-to-end validation together with ‘Be the Patient’ scenario confirmation, in my experience, will usually uncover the bulk of issues that might arise during the course of the study.

Conclusion

If you are looking at applying novel new methods in support of your clinical trial, then take appropriate steps to mitigate the risk of an immature technology or service provider impacting the outcomes. Don’t rush it. If you find you do not have the time to take the steps defined above, then at least consider the risks that are being taken and balance these against a delay in study start.

This article was originally published on LinkedIn on August 24, 2022

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