Seema Verma- Senior Vice President and General Manager, Oracle Life Sciences.
Clinical trials are the backbone of medical research and the impetus behind many new, innovative drugs and therapies. Yet, clinical trials can be long and tedious, which can cause one of the largest roadblocks to moving promising treatments through the pipeline and into the market: low rates of clinical trial patient participation and retention.
According to the National Institutes of Health,1 11% of clinical research sites fail to enroll even a single participant and 37% of sites are under-enrolling. Traditional clinical trial designs have failed to address this issue and are often inundated with recruitment and retention challenges because they overlook patient preferences, like at-home drug administration and data collection.
Clinical trial leaders can help solve the problem of patient recruitment, engagement, and retention by thoughtfully incorporating patient optionality into clinical trials. Patient optionality aims to respect the individual needs of patients within clinical trials by incorporating their preferences into the patient experience.
Making Patients’ Lives Easier
Partly fueled by necessity during the pandemic, there are multiple ways of providing patients with new clinical trial participation options. For example, smartphone apps, wearables, and patient apps – collectively known as mHealth – provide patients with the opportunity to report data in real time without leaving the comfort of their homes. These technologies also provide around-the-clock information that can be greatly beneficial to clinical teams. Researchers can now view a real-world picture of how a patient is responding to a treatment instead of relying on select tests and patient data acquired during in-person office visits.
According to a survey by Oracle,2 patient-centric clinical trial approaches, accelerated and necessitated by the pandemic, brought more timely data (48%), improved flexibility for patients (41%), and higher speed delivery (38%). Additionally, while the data collected through mHealth are often massive in volume, 87% of respondents were able to use most (53%) or all of the additional data generated through new approaches.
Patient-centric technologies enable researchers to design clinical trials for the patient’s comfort and convenience, all without compromising the quality of data collected. For the patient, these new options provide the flexibility and convenience for them to more easily participate in clinical studies.
This flexibility can take shape in the form of locally administered drugs or flexible online reporting of symptoms, all of which require a shorter time commitment from patients. This is critical because convenience can be one of the biggest barriers to patient participation. Some studies can require hours of commitment every day, unintentionally excluding individuals like full-time workers and parents.
Decentralized patient options and trials also bring accessibility to audiences that may not have historically had access to clinical trials, such as populations with diverse ethnic backgrounds or patients from rural and less-serviced areas. While African Americans and Hispanic Americans constitute 13% and 16% of the US population, less than 5% and only 1% of these populations, respectively, participate in clinical trials.3 By decentralizing trials and providing more patient options, clinical teams can meet patients where they’re at, instead of expecting patients, who are often very sick, to travel to the trial site.
The Need for More
While the industry has made a lot of progress in developing patient-centric approaches, the methods are far from perfect. New technologies can be costly to implement and often create more complex work for investigators and site staff, requiring more resources to review, manage, and interpret large volumes of data. Additionally, patient optionality doesn’t fully address the lack of diversity in clinical trials – while it may boost participation from certain populations, it doesn’t address the shortage of enrollment from populations that lack access to technology, for example.
Moreover, due to the minimal regulatory guidance today surrounding decentralized trials and data collection, clinical teams can be hesitant to incorporate these options into their research. The industry had the same uncertainty when wearables and IoT sensors first debuted. It’s understandably a challenge to embrace and get comfortable with new approaches; however, instead of shying away from these new, powerful technologies, we must develop the competencies we need to utilize them to their full potential.
Patient optionality isn’t the panacea for all clinical trials, but it is a cornerstone of patient-centric clinical trials. Technology has and will continue to be instrumental in bringing about significant improvements in the patient experience but there is more work to be done. By addressing challenges, leading with a patient-centric mindset, and leveraging the newest technologies, we can create a more personalized, inclusive, and seamless patient experience.
References
1. National Institutes of Health, Recruitment and retention of the participants in clinical trials: Challenges and solutions, Chaudhari et al. (2020), https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC7342338/
2. PharmaIntelligence, Clinical Trial Data Management In The Post-COVID Era, Oracle, https:// www.oracle.com/a/ocom/docs/industries/life-sciences/clinical-trial-data-management-post-covid-era.pdf
3. National Institutes of Health, Inclusion of Racial and Ethnic Minorities in Cancer Clinical Trials: 30 Years After the NIH Revitalization Act, Where Are We?, Mutale (2022), https://www. ncbi.nlm.nih.gov/pmc/articles/PMC9881739/
Publication Details
This article appeared in Pharmaceutical Outsourcing:
Vol. 4, No. 24
Oct/Nov/Dec 2023
Pages: 24-25
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