Patient centricity continues to gain steam as a critical component to any well-run clinical trial. Many pharmaceutical companies have invested in a strategy to focus more on the patient experience, and certain pharmaceutical companies have gone so far as to create Chief Patient Officer roles to drive this focus.
Despite growing attention, however, there are still open questions regarding what patient centricity is, who should be involved in driving additional focus on the patient, and how patient centricity is accomplished and measured.
Most patient-centric investments have centered on culture change to begin treating patients as “participants” rather than “subjects” of a study. As patients begin to act more like traditional consumers – with access to more information – it is critical to treat them more like consumers, including services and solutions that improve their experience.
The most visible patient-centric technology investments to date have been focused on tools or applications that help life sciences companies communicate with these patients in an effort to close a historical Sponsor-Patient communication gap. These efforts have made progress in beginning to recognize patients as the customer of a clinical trial, while ensuring that patient safety receives significant attention.
As a result, Clinical Operations (ClinOps) has only been a small part of this discussion. As a 25-year veteran in the industry, my perspective is that ClinOps has a critical role to play in improving the way pharma is partnering with patients to execute better and more efficient clinical trials.
Poor data quality drives poor patient experience
Clinical Operations leaders have a well documented data quality problem. With both internal and external resources creating multiple data sources across a variety of sites and studies, it is challenging to aggregate information into one centralized system. Most current processes rely on manual compilation of this data, which means that it quickly becomes stale. And even when it is compiled, it can be tough to separate a signal from the noise. ClinOps leaders are therefore forced to make decisions with outdated and complicated data sets that are pieced together through manual processes.
The implication for patients is that it is difficult for ClinOps to see which sites or patients are having a poor patient experience. In some cases, this challenge could result in a failure to see a high rate of protocol deviations for a given site and, subsequently, the need for a protocol amendment. In more extreme cases, this challenge could be represented by the failure to quickly respond to an unexpected serious adverse event, and, as a consequence, expose the trial to the risk of an FDA inspection. In any case, the patient is having a poor clinical trial experience and the sponsor is failing to meet their standard for patient centricity.
Improve clinical data quality to improve the patient experience
ClinOps leaders can simultaneously improve the patient experience and reduce operational risk if they invest in automation. Rather than rely on a manual process to compile outdated clinical data that is tough to analyze, they should invest in a system capable of providing both aggregated data and insights on key performance indicators from this data.
Innovative companies have created cloud-based Clinical Intelligence applications built specifically for this purpose. These solutions aggregate data from across clinical data sources, analyze key performance indicators for patient insights across sites and studies, enable monitoring through configuration of thresholds and alerts, and manage proactive issue resolution.
When applied to specific indicators that reflect the patient experience, Clinical Intelligence applications direct ClinOps’ attention to the studies, sites, and specific patients who require the most attention. From patient screen failures during enrollment to protocol deviations during the trial, these solutions ensure that ClinOps is efficiently allocating resources to potential issue areas before they threaten the study.
This proactive, data-driven approach to trial management is proven to reduce the likelihood of missed milestones. Less often discussed, however, is how this approach will also improve the patient experience. By identifying an uptick of protocol deviations in real time, the ClinOps team can address the issue before it leads to a protocol amendment. And by directing resources to these problem sites, ClinOps can ensure that the most at risk patients receive proper attention.Through this process, a better patient experience will be aligned with more efficient Clinical Operations.
The value of a more patient-centric approach to ClinOps
ClinOps has an important role to play in improving the patient experience. With access to accurate and timely insights on key patient-related indicators – powered by Clinical Intelligence applications – ClinOps professionals can act quicker to resolve issues before they more broadly impact the trial. If executed well, this proactive approach to issue management will result in an improved patient experience.
Clinical Intelligence applications are available to be implemented today, and some ClinOps leaders are already taking advantage of them.Their impact will only grow over time as they become more integrated with patient engagement tools to improve the patient experience.
Filed Under: Drug Discovery
