Understanding Heuristics and Biases in Clinical Trial Decision-Making

Applied Clinical TrialsApplied Clinical Trials-06-01-2024
Volume 33
Issue 6

Highlighting the inherent risks associated with subtle biases in clinical research practice, as well as the most proven strategy for mitigating each risk.

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc.

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc.

In our journey through the lessons of cognitive, behavioral, and learning sciences, we’ve introduced a variety of insights that can significantly impact the effectiveness of clinical trials. Just as we’ve seen in previous articles, such as “Battling ‘Sludge’ in Clinical Trials” and “Beyond the Iron Triangle,” understanding human behavior is crucial. Now, we turn our focus to some cognitive shortcuts—known as heuristics—and biases that, while evolutionarily advantageous in many situations, can distort decision-making processes in clinical trials.

Humans have evolved to use heuristics and biases as mental shortcuts to make complex decisions more manageable. While these can be beneficial, offering quick solutions in everyday life, they also present risks when precision and objectivity are required, such as in clinical trial planning, design, and implementation. Our team at ArcheMedX has compiled the top five most insidious biases and heuristics that we, as a clinical trial research community, must recognize and overcome to ensure success of our trials. For each, we’ve highlighted the inherent risk of the bias, as well as the most proven strategy for mitigating the risk.

1. Decision fatigue. This bias occurs as decision-makers face a prolonged series of choices, leading to deteriorated quality of decisions. For instance, sites and staff might unknowingly default to a pre-existing, but less optimal patient recruitment strategy after weeks of wading through trade-offs, compromises, and sacrifices in trial implementation.

Strategy: Mitigating decision fatigue can involve objectively structuring decision-making via tools or rubrics that simplify actions and choices to prevent overload.

2. Confirmation bias. It’s human nature to favor information that confirms our preconceptions. In clinical trials, this might manifest when researchers pay more attention to data that supports their hypotheses while disregarding contradicting evidence.

Strategy:To counteract this, clinical trial sponsors might identify specific team members empowered to play “devil’s advocates” and challenge decisions that might be influenced by confirmation bias.

3. Bounded rationality. This bias reflects the limits of our decision-making capabilities, particularly under conditions of incomplete information. Clinical trial designers might over-confidently rely on familiar methods without considering newer, potentially more effective alternatives.

Strategy: Embracing continuous improvement methods and strategies (i.e., plan-do-study-act cycles) can help widen the scope of rational choices.

4. Commitment bias. Teams often default to established approaches to trial start-up, ignoring signs of its inefficacy due to past commitments. We see this in almost every trial we support—trial sponsors and CROs fall into prior habits of ineffective and inefficient site initiation visits and trial-specific training (as the most costly example).

Strategy: It’s critical to ensure that each new trial is designed and implemented leveraging current best practices vs. the “way-we’ve-always-done-it” approach.

5. Anchoring bias. This occurs when individuals rely too heavily on an initial piece of information to make subsequent judgments. For example, making an initial assumption about what is driving screen failure rates rather than objectively reviewing screen failure data to make adjustments.

Strategy: To combat this, ensure objectivity through schedule/periodic data reviews and set an expectation for challenging assumptions.

Embracing cognitive challenges

Recognizing and mitigating these biases is not just about enhancing the objectivity of clinical trials; it’s about embracing the complexities of human cognition to propel our work forward. Each trial offers a unique set of challenges, but also opportunities to refine our approaches and learn from our cognitive tendencies.

As we continue to navigate these cognitive landmines, let us remain vigilant and proactive. By understanding and addressing these biases, we not only enhance the integrity of our trials but also accelerate the development of life-saving drugs and devices. Our commitment to cognitive “rationality” is essential for ensuring that our trials are as effective and efficient as possible. But to reap the benefits, our community must embrace these lessons and build on them.

Brian S. McGowan, PhD, FACEHP, is Chief Learning Officer and Co-Founder at ArcheMedX, Inc.

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