As the COVID-19 pandemic continues to spread globally, pharmaceutical and biotechnology companies are struggling to keep clinical trials running. Not only are patient visits to clinical sites more difficult (or impossible), patients are also dealing with uncertainty, stress and anxiety. While keeping ongoing trials running is a top objective for many, understanding how this myriad of factors will affect trial data is paramount. How can data from patients enrolled before the COVID crisis be compared with data collected after the pandemic started? How can patients enrolled before the COVID crisis be compared with patients enrolled after the COVID crisis? Will trial patients achieve a “new normal” – and if so, when will that occur and what will it look like? We know that patients and thus trial data will be impacted; the major question is how will they be impacted and to what extent?
While the industry of course doesn’t have answers to these important questions, the first step lies in understanding the impact of this crisis at the individual patient level. It is well-documented that patient psychology has been associated with issues such as the placebo response and medication compliance and is known to drive patient behavior in clinical trials. Each trial patient will perceive and respond to the stress created by the COVID-19 pandemic – including the necessary changes to their clinical trial – in a way that is unique to their psychological traits. It is intuitive that a patient who is naturally more optimistic may experience a smaller impact on outcomes, while patients who are more anxious may demonstrate larger fluctuations in data. This fundamental variability between patients in their response to the COVID crisis will add yet another layer of data variability – that may compromise the ability to identify treatment efficacy.
To begin to understand this, Tools4Patient reviewed data from clinical trials running during the terrorist attacks in Paris in November 2015. A total of N=89 local patients were enrolled before the terrorist attacks, while a total of N=62 patients were enrolled after the attacks. In these studies, patients were given questionnaires to evaluate multiple facets of their psychology at baseline. Psychological data generated were related to the patient’s placebo response and used in the development of Placebell©™. Despite the small sample size, differences in questionnaire items were noted between patients enrolling before and after the terrorist attack. For example, patients enrolled after the attack answered the following statements differently: “I feel that I usually get in life what I deserve”, “People are generally treated with fairness”, “I feel that people usually get in life what they deserve”. These questions describe how individuals conceptualize the world and have been related to stress, depression and coping. This confirms that psychological profiling may be adequately sensitive to detect potential differences in clinical trial patients’ response to crisis.
The impact of the COVID-19 crisis on ongoing clinical trials extends beyond inducing patient stress – it is fundamentally altering the way patients interact with trial sites and trial staff, the way patients report outcomes and the way patients exist in social structures. Disassociating these factors from treatment efficacy when analyzing data is an unprecedented challenge – yet, this is the challenge that so many biotech and pharma companies must face. Before considering how to account for data convoluted by to the pandemic, it makes sense to strive to understand which patients are impacted, how are they impacted and to what extent are they impacted? This requires first gaining an understanding of trial patients along 4 critical axes – innate psychological traits, expectation, patient perception of clinical site staff and environment (i.e. contextual factors) and social factors.
Over the last 6 years, Tools4Patient has developed a suite of questionnaires to examine these factors, along with accumulating historical data from clinical trial patients and developing models to predict patient response to treatment. This platform serves as the basis of COV-IQ, Tools4Patient’s approach to profile patients in ongoing clinical trials. Sponsors can now gain an additional level of data describing trial patients to better understand how patients have changed and how they are evolving over time. The applications of this type of data range from qualitative descriptions to better explain data anomalies, to guiding data analysis strategies, to using our machine learning platform for more sophisticated approaches to reduce data variability. The extraordinary challenges to drug development created by the pandemic require novel, creative solutions. It is our sincere hope at Tools4Patient that our expertise in patient profiling will help biopharma companies address some of the complex and unprecedented obstacles arising during this crisis.