Bias and Decentralized Trials

How To Prevent Biases in Clinical Trials

Mary Costello has spent over thirty years in the healthcare and clinical research fields, working in commercial leadership roles with lar...

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Avoiding bias in clinical research has been an important concern of drug makers worldwide and is part of what guides oversight on every level.  As we move into an era of opportunity to expand clinical trial inclusion via the power of technology, we will also need to ensure that we don’t create the conditions for bias as a result of access to devices or wifi.

What do I mean by that statement?  Successful decentralized trials will rely heavily on a reliable internet signal capable of transmitting data on a regular basis.  Much of the new technology offered to support DCTs comes with the convenience of collecting data through patients’ laptops or phones, which provides an ease of participation that did not exist in traditional RCT models.  However, these interactions with patients presuppose that they will have phones capable of working with apps (iPhones or Androids), or that they own a laptop and that they have a consistent and reliable internet signal.

It is heartening to see a national conversation turn in the direction of diversity and outline guidance and the necessity of expanding clinical research access to a broader community.  But project planning that fails to account for the variety of scenarios that exist today – especially in some of our lower income communities -- will mean that by default, these same communities that are at the forefront of the conversation will continue to get left behind. To prevent this, project planning must proactively introduce ways of provisioning devices and ensuring access to a strong signal as a key part of widening the inclusion opportunities for all patients.

Sites must be at the forefront of this planning. They will need to understand what challenges may exist and be provided with the support and budget to remove any technical barriers that may prevent participation or continuation in a study. While this may seem like a fairly straight-forward task, there is a danger in not considering the breadth of challenges facing some patients. For example, consider the experience of one site where, at the height of COVID, participants in a trial without home access to adequate wifi were asked to travel to their local library, daily, to upload their diary details.  Yes, that was in the midst of a pandemic.  Realizing the difficulty in this, the site asked for hotspot support but the sponsor did not want to allow this additional request.  The result? Many of the participants dropped out, depleting the numbers and introducing systematic bias in the sample.

I would encourage sites to begin collecting data that will help gauge the technical situation of their patients.  This could be as simple as emails, whether participants are able and willing to communicate via text, what type of phone they have, whether they have wifi at home, and, importantly,  asking them to rank their comfort level with technology.  Having this information at the ready will help with pre planning, device support, and other critical information that will help assess their ability to support the study while creating a budget to do so.  For research  sites with an associated healthcare practice,  EMRs may already have collected some of this information, providing them with a useful first step in planning.  

In summary: If we know that today’s trials have inherent bias, then we must make sure future trials include everyone, from all types of communities and all types of situations.