The real value of patient input in clinical trials

In recent years, there has been a real push for patient centricity and patient input in both the clinical trial space and in the greater healthcare industry, but why is this? 

Scholarly research, particularly over the past ten years, has suggested that there are indisputable benefits to involving patients in clinical trials and incorporating patient input in clinical trial designs. However, this is easier said than done and the adoption of greater patient involvement in clinical study designs and development processes sparks a need for reimagining how trial designs are developed and who needs to be involved. 

The first step is understanding the value of patient input and what that really means in a clinical trial setting.

Why is patient input important? 

Patient Satisfaction 

One of the most straightforward and seemingly obvious reasons why patient input is important is to ensure patient satisfaction, yet this is also one of the most overlooked aspects of trials. “Patient-reported outcome measurements (PROMs) are the most overlooked vital sign of healthcare systems,” according to Puneet Seth, MD, a physician, author, and part-time assistant clinical professor. But why is this? Seth remarks that “the terms patient-centered care, patient experience, and value-based care are meanwhile thrown around as catchphrases while the underlying concepts have yet to be meaningfully implemented.” 

The real value, however, of patient-reported outcomes can be argued as quality of life. In a scholarly review of “tens of thousands of patients and a wide variety of cancers” studying health-related quality of life and cancer clinical trials, it was found that “there is still a need for a clear method for determining the clinical meaningfulness of changes in scores.” Not only do these outcome reports help to inform decisions around patient care and symptom management, but they can also be used for protocol development and study design. 

Impact on Study Findings

Patient satisfaction is not the only patient-experience-related data that is important in clinical trials. “Advances in medical care begin with research that emphasizes outcomes meaningful to patients,” states The Patient-Centered Outcomes Research Institute (PCORI) National Priorities for Research and Initial Research Agenda authored by J. V. Selby, MD, MPH, et. al., which sets a purposeful call to action for the need for patient involvement in study data. An article from the National Library of Medicine by B. Hefele, et al., states lack of patient-reported data can result in “using inappropriate outcome measures and poor interpretation, and dissemination of research findings” and that “too often, clinical studies culminate with a multitude of data, yet analyses and recommendations fail to translate into practice, leaving unmet needs for patients.” The message being – there are inherent consequences to neglecting patient input in clinical trials when it comes to synthesizing and generalizing study results that can ultimately be misleading and non-indicative of the true patient experience. 

There are many cases where data collected from patients on the feasibility of use is crucial. This is particularly true in medical device, digital therapeutics, and diagnostic trials. Understanding how patients interact, use, and understand a product, test, or digital therapeutic is a huge portion of gauging the success of a process or treatment protocol. If patients are unable to properly use or understand an intended treatment, there needs to be a means for collecting that patient feedback. 

Patient engagement

Why is patient engagement important in clinical trials? Most if not all clinical trials cannot succeed or move forward without patient engagement and patient retention. According to the Clinical Trials Transformation Initiative (CCTI), “Incorporating perspectives from patients and patient organization leads to more meaningful clinical trials with increased feasibility, enhanced recruitment and retention, and real-world outcomes.” Patient engagement in clinical trials is not only key to the collection of PROs but also to collecting almost all other significant data needed in a clinical study. 

Having a database of patient-reported data from a variety of clinical studies can be one of the best resources for incorporating patient input. Some trial service and DCT vendors can aid in study design making informed decisions based on data-driven intelligence from historical experience. Overall, valuing the collection of patient data and incorporating patient input in clinical trials as early as the design phase can help with patient retention, enrollment rates, trial recruitment timelines, and data quality for an overall clinical study.

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To learn more about building out a DCT study, read about Why you need to engage DCT study vendors earlier to assist in designing decentralized clinical trials.