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3 Considerations for Creating a Patient-First eCOA Solution

Digital Health technologies are evolving at an unprecedented pace, offering clinical research stakeholders' achievable means to deploy studies with greater speed and accuracy.

Traditionally, study teams have worked closely with eCOA vendors to translate protocols into detailed solution designs. These specifications are then converted into front and back-end software experiences for data collection and monitoring. Implementing eCOA in a trial is a major task and may be the most complex component of a study that can be tied to primary or secondary endpoints. The integration between technology and numerous stakeholders means the pressures are very high to get things right the first time. Unfortunately, there are still too many failures in quality and timeliness with eCOA launch that directly harm the key protagonist of our industry: the patients.

In our quest as an industry to get meaningful novel treatments to patients faster, we must evolve how we use eCOA technologies by operating differently – this means new pragmatic processes.

At the same time, researchers are working hard to create more accessible activities (think inputs) for patients so they can get in and get out quickly - but what if we did both? Unfortunately, it's not as simple as it sounds but the reality is any truly functional eCOA strategy will require a creative approach to both inputs and processes. Below are three considerations to take as you get started on your journey of putting the patient first in your eCOA.

1. Understand the Problem

Albert Einstein once said, “If I had an hour to solve a problem and my life depended on the solution, I would spend the first 55 minutes determining the proper question to ask, for once I know the proper question, I could solve the problem in less than five minutes.”

Consider putting the patient at the forefront of your work. During protocol design, think about the tasks you are asking the patient to undertake and the treatment they are going to endure. Think about the likelihood of them completing those tasks and then the schedule by which they are expected to repeat it. Then put that into context with how likely it is for you to get the data set that you need to prove the safety and efficacy of your treatment. Concerned yet? Consider engaging with a PCOR (Patient-Centric Research Outcomes) team to help you design a protocol that is fit-for-purpose and likely to get you the data you need. You may find that you don’t needall the eCOAs you planned to use at baseline, during treatment, and that the proposed pathway not only gets your patients engaged but gets you your data faster. Better designs mean more complete patient data, fewer dropouts, and less effort to figure out your results.

Next up, listen to your patients – through both traditional means like focus groups and through non-invasive technology offerings that assess emotional response. The more you know what matters to your patients, the more you understand the methods you will need to keep them engaged across all demographics and geographics. The results will surprise you, but they will also provide you with the confidence to invest in what is keeping the patient enrolled and engaged in the study.

2. Visibility Leads to Predictability

With research becoming increasingly competitive these days, speed matters. When selecting a vendor or a platform to drive your clinical research, think about how you can eliminate variation from the work:

  • Leverage easy to use interfaces to rapidly design out your solutions, verify the results, and iterate without wondering what is going on in the background while you lose time.
  • If you have the core competency or appetite to build your own studies, consider a platform that offers you that flexibility – removing the back-and-forth translation of your needs and the wait time to go through expensive design, build, and test gates only to fail in UAT (User Acceptance Testing).
  • Operate with libraries – the more standards you can create and re-use, the better. This gives you a validated, version-controlled item that you can move between visits, studies, and even customers where it makes sense.

Taking eCOA off the critical path, with a complete no-code platform and integrated eCOA Instruments that are ready for study licensing will help you achieve your study goals quicker and drive repeatable success across your research portfolio.

3. Flexibility Leads to Repeatability

Now you understand your problem, your solution is built, and you’re ready to deploy to the first patient, first visit. Back to our protagonist. Patients are looking to us all, to provide care during a time that nothing else is available to them. That care itself is often invasive, sometimes frightening, and the last thing needed is a technology burden. Our everyday life is an unknown journey, a journey that responds best with a flexible toolkit at the helm to perform our daily tasks. Consider a platform that serves a seamless omni-channel experience to your patients. One where they get to choose how to participate, and not just at enrollment. Enable your patients to put what matters to them at the center of how they spend their day. Hint – it’s probably not an eCOA technology. The best platforms don’t force a particular modality on a patient – they offer options to get enrolled, stay informed, capture what is necessary, and report on their progress – pivoting where it suits them, while still preserving the same data integrity for your research.

Patient-First eCOA: a real experience, designed by patients for patients - powered by the engagement capability of the THREAD research platform. To find out more – visit THREADresearch.com.