3 Trends in Clinical Trials that Make it All About the Patient

With the rise of personalized medicine –an approach to healthcare that uses a person’s unique genetic make-up– it’s no surprise that many of the current trends in clinical trials put the power back in patients’ hands. At Caligor Coghlan, our focus is helping innovators and researchers deliver life-changing therapeutics to patients faster, and we’re especially excited to see the rise in patient-centric solutions.

Patient-Focused Technology

Wearable devices. Remote monitoring. Virtual visits. New technologies are combining that make clinical trials easier and more accessible for patients. Imagine you’re a busy parent juggling childcare and work; simply eliminating the need for a babysitter to attend a clinical visit can make all of the difference in continuing in the study. These newer technological solutions make tracking and appointment scheduling less burdensome for study participants, which can have a significant impact on recruitment and retention.

Wearable devices can also help in reporting consistency and data collection. After all, how many of us could accurately track our steps, sleep, or how many times we interact with others in a given day? But these markers can provide helpful indicators for a host of conditions from obesity to depression.

Some researchers are also using a comprehensive patient portal that allows participants to schedule appointments and manage travel, process payment reimbursements, and generally monitor all aspects of their trial. Just as beneficial on the researcher’s side, clinical trial sponsors and staff have access to real-time data, allowing them to better serve the needs of individual patients. [source]

Social Media & Patient Engagement

Though we’ve seen many improvements over the past two decades, patient recruitment, engagement, and retention are still some of the most challenging aspects of conducting clinical trials. Nearly 80% of clinical trials fail to finish on schedule, with 20% delayed six months or more. A staggering 85% of studies cannot retain enough patients, with more than two-thirds of trial sites failing to meet targeted patient enrollment quotas. [source]

Thanks to social media, we’ve seen increased opportunities for patient engagement. These platforms and tools can help match patients with the right clinical trials and speed up recruitment (ultimately saving time and money, getting medicine to patients faster).

Furthermore, social media can impact the diversity of recruitment for trials. According to a 2020 NIH study on The Role of Social Media in Enhancing Clinical Trial Recruitment, social media offers distinct benefits in its ability to use customized messages on platforms that have a higher proportion of users from minority groups. Which brings us to the final of three exciting, patient-centric trends in clinical trials…

Clinical Trial Diversity & Access

Our health isn’t based solely on family history and lifestyle. Our environment, socioeconomic status, sexual orientation, gender identity, and lived experiences (to name just a few) all impact our physical and mental well-being. Access to healthy foods, health care, and education play a part, too.

Historically, clinical trials enrolled almost entirely white male participants, overlooking the variations that come from studying different biological sexes and ethnicities. According to the National Institute on Minority Health and Health Disparities, “this shortcoming has created gaps in our understanding of diseases and conditions, preventive factors, and treatment effectiveness across populations.” Including a diverse population in clinical trials helps researchers achieve a more robust dataset, ultimately allowing clinicians and healthcare professionals to give better counsel and treatment responses.

A cruel history of exploiting minority populations in clinical research means one critical step in creating clinical trial diversity and access is building trust. Another key step is collecting the right background data and aggregating it appropriately: socioeconomic status, sexual orientation, gender identity, and specific nationality.

While the path forward is complex, there have been promising markers of progress:

Rise in Decentralized Trials: During the COVID pandemic, there was a spike in decentralized trials, leveraging the use of digital technologies like telehealth and remote patient monitoring which helped expand access to diverse populations. In May, the FDA published draft guidance for industry stakeholders on implementing decentralized trials, stating that these trials “have the potential to expand access to more diverse patient populations and improve trial efficiencies.”
NIH Diverse Trials Act of 2022: In addition to carrying out a national campaign to increase awareness about the need for diverse clinical trials, the National Institutes of Health (NIH) Diverse Trials Act of 2022 states that any entity seeking public funding through NIH must provide a clinical trial diversity plan when applying for funding.
Industry Progress: In 2022, PhRMA conducted a survey (included in their Industry Efforts to Enhance Clinical Trial Diversity Report) that showed 97% of their member companies were reporting that they were taking specific measures to address access issues for clinical trial participants. According to the report, “Eighty-seven percent (87%) of these member companies were adapting protocol design to increase diversity, including the use of decentralized trials, remote trials, and mobile technology. And 84% reported working to increase patient education and awareness of clinical trials.” [source]

At CalCog, we have 28 years of experience in clinical supply management and logistics, and we are committed to leveraging our expertise in service of all patients everywhere.

We are excited to see these trends continue to develop and positively impact patient access to life-changing therapeutics.

ABOUT CALCOG

CalCog has been dedicated to supporting the clinical trial supply chain since 1996. With the infrastructure, expertise, and quality management systems of a large company and the speed and responsiveness of a small company, CalCog is a valuable clinical supply resource for small and medium-sized pharmaceutical and biotech organizations.

We strive to find the best ways to support the clinical supply needs for every clinical trial, overcoming physical and regulatory barriers while maintaining the flexibility needed to meet client timelines.