In the medical research realm, clinical trials stand as vital pillars, shaping the future of healthcare by advancing our understanding of diseases and formulating potential treatments. Yet beneath the surface of these breakthroughs, a myriad of challenges and pain points often prevent most trials from being completed. 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.
These delays have an immense financial impact on trial sponsors and clinical research organizations (CROs). While estimates place potential industry losses at between $600,000 and $8 million per day, the actual cost is highest for those suffering from chronic illnesses without a cure. Lengthy delays slow researchers’ ability to quickly market new medications and treatment options, negatively affecting those needing them the most.
In this article, we uncover three pivotal best practices aimed at mitigating these clinical trial pain points. By leveraging state-of-the-art technology, reducing travel burdens, and placing patient-centered support services at the forefront of trial design, we can reshape the trial experience, propelling medical research toward heightened efficiency and accessibility.
Embrace Digital Transformation
Over the last decade, the healthcare industry has experienced a swift and extensive digital transformation. The integration of innovative technologies has empowered healthcare providers to enhance their internal operations, provide streamlined care, and respond more effectively to patients in critical situations. With the rise of telehealth consultations and the evolution of wearable medical devices, the potential for digital transformation to revolutionize clinical practices is promising.
One of the most pivotal breakthroughs is the integration of wearable devices. These devices have emerged as critical players in alleviating the challenges associated with data collection and monitoring in clinical trials. Equipped with sensors and real-time data tracking capabilities, wearables enable continuous monitoring of participants’ vital signs, activity levels, and overall general wellness. This technology reduces the need for multiple physical visits and ensures a more comprehensive and accurate representation of participants’ health statuses throughout a trial’s duration.
Furthermore, telemedicine and virtual visits have emerged as a transformative force in clinical research. By leveraging secure digital platforms, researchers can remotely engage with participants, assess their progress, and address any concerns without the constraints of geographical distances. These advancements not only streamline the study process but also reduce the need for participants to travel frequently, significantly reducing the associated challenges related to in-person appointments. Virtual visits are particularly beneficial for patients suffering from severe cognitive or mobility impairments, in which extensive travel is often not a viable option.
Mobile applications have also become handy tools for modernizing data collection and participant engagement within clinical trials. Participants can conveniently report their data, track adherence to protocols, and engage with the trial’s progress through user-friendly apps. These platforms enhance convenience and foster a sense of active engagement among participants, which can positively impact trial outcomes and retention rates.
Offer Assistance with Trial Logistics
As mentioned above, the logistics involved with getting to study sites remain one of the driving forces of poor trial recruitment and retention. An independent study from Clincierge found that over 60% of patients cited travel as a primary reason for deciding not to participate in one or more clinical trials. Similarly, 91% of caregivers said travel was stressful for themselves, their participating loved ones, or the rest of their family.
Consider a scenario in which a patient in rural Pennsylvania suffers from an ultra-rare disease with no FDA-approved treatment. They are offered an opportunity to participate in a potentially lifesaving clinical trial, but it takes place in Turkey. While the patient might be eager to participate, they now have to manage the logistics of cross-border travel. This opportunity prompts an abundance of questions for the patient and their family: How do I obtain a visa(s)? How do I manage documents and paperwork in a language I don’t speak? Am I responsible for coordinating air and ground travel? What about booking a hotel? Managing these logistics while undergoing an experimental treatment can be overwhelming.
Investing in solutions for logistical issues such as these significantly reduces the burden placed on patients, making them more likely to enroll and participate in the entire trial. Offering assistance aligns with the broader goal of making clinical trials accessible to a more comprehensive range of individuals, regardless of their geographical location or economic circumstances. By removing the complexities associated with travel, study sponsors and CROs can create a more inclusive environment reflecting the diversity of patients who stand to benefit from cutting-edge medical advancements. This approach demonstrates a compassionate understanding of participants’ unique challenges and underscores the commitment to their contributions to medical progress.
Invest in Patient Concierge Services
Beyond travel assistance, study sponsors and CROs should consider offering comprehensive patient support services from a designated patient concierge company. Much like a hotel concierge, a patient concierge manages all logistics of study participation. These services include itinerary planning and ticketing, reimbursement facilitation, visa and passport assistance, and more.
Patient support encompasses a variety of approaches. In certain instances, this assistance means having a designated individual to address any inquiries or uncertainties a participant might encounter regarding trial logistics and design. According to a Clincierge survey, an overwhelming 95% of patients emphasized the importance of having a singular point of contact to aid them throughout the clinical trial process. Ideally, a patient concierge is situated within the patient’s country of residence, fluent in their language, and readily available throughout the study. This individual establishes a personal rapport with the patient, offering an understanding of the nuances of their experiences and the region where their trial occurs.
Investing resources in patient support programs benefits trial sponsors in several ways, including:
- Improving recruitment, retention, and diversity efforts by reducing barriers hindering patients’ willingness to participate and remain in a trial
- Ushering life-enhancing and lifesaving therapies to market faster, as making day-to-day aspects of the trial easier for participants results in fewer delays
- Collecting better data, as an improved patient experience results in less pressure placed on them, mitigating the impact of stress on the integrity of trial data
Bottom Line
In the dynamic world of medical research, clinical trials stand as beacons of innovation, yet various pain points continue to threaten their progress. While strides have been made, issues like patient recruitment, engagement, and retention remain serious challenges, causing significant delays and financial strain. Adopting the three pivotal best practices mentioned above can revolutionize the clinical trial landscape and create improved patient experiences and trial results.
