Contributed Commentary by Scott Gray, CEO of Clincierge  

July 21, 2023 | Healthcare and technology have always been inextricably linked, with medicine's earliest innovations still playing a central role in modern healthcare. Take, for instance, the discovery of X-ray technology in the late 1800s, which paved the way for a myriad of medical advancements, including electrocardiograms, CT scans, dialysis machines, and more. A more contemporary example is the application of AI and machine learning within healthcare, which equips providers to create more efficient processes, predict and improve patient outcomes, and potentially reduce overhead costs. 

Within the clinical trial industry, the convergence of healthcare and technology has led to a constant stream of advancement, driving the development of novel treatments and therapies. The COVID-19 pandemic further underscored technology's crucial role in enhancing the patient experience with the subsequent rise of decentralized trials (DCTs). To ensure patient care remained uninterrupted in 2020 and beyond, clinical research organizations (CROs) and study sponsors significantly embraced digital transformation by prioritizing remote connectivity. 

While trial efficiency has steadily improved over the last decade, patient recruitment, engagement, and retention continue to be pressing issues. Nearly 80% of clinical trials fail to finish on schedule, with 20% delayed six months or more. While the reasons for these delays vary, 85% of studies cannot retain enough patients, with more than two-thirds of trial sites failing to meet targeted patient enrollment quotas. By embracing digital transformation, CROs and trial sponsors can prioritize patient engagement while improving recruitment and retention rates, leading to more cost-effective and efficient studies. 

The Cost of Poor Engagement

The United States spends more on healthcare than any other country globally, but individual health outcomes are lower than in most developed nations. Clinical trials account for nearly 40% of the US pharma research budget, totaling around $7B annually. Estimates place the cost of patient recruitment as approximately 40% of the total budget, or $1.89B.  

Individual trial costs can vary greatly, driven by several factors, including the number of patients required to establish a treatment’s efficacy and the number of site visits needed for the treatment to be effective. At one time, the median cost of clinical trials for new drugs seeking approval from the US Food and Drug Administration (FDA) was estimated to be $19 million. Given these figures, one can imagine the enormous financial impact of losing even a single patient mid-trial. 

While the primary objective of successful trial completion is the improved quality of life for patients suffering from chronic disease or illness, the return on investment will always be a critical consideration for CROs and trial sponsors. Much of a drug’s success can be attributed to trial participants, without whom the new treatment would not achieve mass commercialization. The patient experience is pivotal to completing trials and sits directly at the intersection of the humanitarian mission and business motivation for drug development. 

Building Upon DCTs

In 2020, study sponsors relied heavily on decentralized clinical trial (DCT) models to keep existing studies on track and launch new trials while adhering to evolving pandemic protocols. According to Florence Healthcare’s 2023 State of Site Enablement, 26% of study sponsors reported using DCT models for almost one-third of their studies. Only 11% indicated they were not using DCTs for their trials.  

While the popularity of DCTs grew in 2020 and 2021, sponsors returned to a focus on engaging clinical trial sites in 2022. 58% fewer sponsors reported using DCTs in at least one-third of their studies, and 244% more stated they did not use DCTs.  

COVID restrictions provided CROs and study staff with a regulatory perspective and suggested protocols for implementing remote patient care. These recommendations supplied guidance for conducting patient visits by telephone and video conference, dispensing investigational treatments for self-administration at home, managing lab and imaging needs for patients, and detailing how remote efforts might impact study protocols. While DCTs will never be a one-size-fits-all solution for patients and clinical trial teams, the obligatory adoption of this trial method during the pandemic provided a universal framework to shape the future of how technology can be used as a tool for patient engagement. 

Combining the personal care provided by traditional trials with patient-centric elements of DCTs will be the most effective solution for study design moving forward. A hybrid approach offers the convenience of home care and telemedicine to reduce the number of in-person site visits while administering complex treatments in the safety of a controlled clinical setting. This hybrid application makes the trial commitment more manageable by reducing the burdens placed on patients and their caregivers, ultimately improving participant retention rates. 

Digitizing the Patient Experience

Emerging technologies provide the opportunity to maximize efficiencies through every phase of a trial. In addition to wearable devices and telemedicine allowing for remote connectivity, there are also opportunities to digitize how CROs and trial sponsors collect and manage patient data, feedback, and administration.  

As mentioned, patient recruitment and retention are significant impediments to successful trial completion. Research suggests only 5% of eligible patients participate in clinical trials. While various factors contribute to this statistic, the reality is that most of the time, eligible patients are unaware a study is being conducted for their condition, begging the question: how can we reach the right patient population while also being mindful of individuals' protected health information?  

Companies like BEKHealth are addressing this issue head-on by manufacturing direct-from-electronic medical record (EMR) data processing and patient-trial matching software. By compiling various pieces of medical data into one centralized archive, these new technologies can predict which particular illness or disease a patient may have, making it easier than ever to identify and contact potential study participants. 

Beyond the recruiting phase, embracing a digital-first patient management approach can make the logistics of trial participation much simpler, leading to an improved participant experience. Creating a comprehensive patient portal system can allow patients to manage and monitor all aspects of their trial, including scheduling appointments and check-ins, managing travel (if applicable), and processing payment reimbursements. These portals can offer clinical trial sponsors and site staff real-time monitoring capabilities, allowing them to better cater to the needs of individual patients.  

While these data management platforms can significantly enhance the patient experience, trial staff should always offer personalized human support in addition to technology initiatives. Having a single point of contact goes a long way in making participants feel comfortable, included, and heard.  

Bottom Line

As the clinical trial space continues to embrace digital transformation, there is great promise in improving patient engagement, recruitment, and retention, thus bringing more life-saving treatments to market more cost-effectively and efficiently. 

However, it is equally essential to keep patient-centric solutions prioritizing privacy and security top of mind, while maintaining a human touch throughout the length of the trial. Combining one-on-one patient concierge support services with the adoption of emerging technologies will be imperative to streamlining participant experiences in the years to come. 

Scott Gray is the co-founder and CEO of Clincierge, the leader in patient support services for clinical trials. Since 2015, Clincierge patient coordinators have managed logistics and reimbursements for more than 300 clinical trials worldwide. Gray can be reached at scott.gray@clincierge.com.