There are several emerging trends in clinical trials for biopharmaceutical and biotechnology companies. A leading area is the transformation from traditional site-based clinical trials to trials that have a considerably reduced site footprint (hybrid trials) and those that can be conducted 100% remotely (decentralized clinical trials, DCTs). While these types of patient-centric, less burdensome trials were already beginning to see increased adoption, the COVID-19 pandemic catapulted hybrid and DCT’s into the mainstream across therapeutic areas and proved to be a more efficient and reliable solution to many of the common pain points encountered in traditional clinical trials.

The advancement of tech-enabled clinical trials allows for patients to be:

  • recruited through social media
  • electronically screened for eligibility
  • provided informed consent electronically
  • digitally trained
  • shipped investigational products and supplies
  • providing biospecimens through DIY kits and return shipments
  • completing electronic patient reported outcomes (ePRO) and eDiaries
  • taking and uploading photos, audio and videos for analysis by a central rater or algorithm
  • reporting potential adverse events (AE) and serious AE (SAE) in real and near-real time
  • having their potential AE/SAE monitored and triaged in real and near-real time
  • interacting with a virtual clinical site team (physicians, nurses, principal investigator, clinical research associates) using live chat, email and phone support in a bidirectional capacity
  • monitored continuously or at points in time using FDA-approved wearables and biosensors
  • provided payments
  • alerted by notifications, alarms, reminders and engagement strategies
  • interacted with by doctors and nurses using telehealth visits
  • directed to a centralized lab for blood draws
  • utilizing home health care visits for needed in trial tests

    all from the comfort and convenience of using an app on their own personal smartphones.

      Relieving Site Burden

      Clinical sites are more burdened than ever with staff and supply chain shortages. Increased site staff turnover further exacerbates the inherent variability that is imparted on a clinical trial from the many raters and staff contributing to the dataset in a clinical trial. Hybrids and DCT’s provide a solution that is beneficial to all stakeholders.

      Data uploaded by patients to the cloud is continuously monitored and source data verified. Algorithms enable connected devices and ePRO data to be analyzed and acted upon in near real time.
      SPRIM Health, while rooted in traditional clinical trials for over 22 years, has become a global leader in the transformation of trial designs and implementation to hybrids and DCT’s. SPRIM Health clinical trial clients span from large global multinationals, to emerging leaders and start ups. We have considerable experience across all therapeutic areas and our in-house experts have designed and implemented over 500 clinical trials. We are particularly adept at applying creative solutions that are uniquely tailored to our client’s needs.

      We believe that quality is optimally delivered through the combination of clinical science and technology, understanding our clients pain points in a given therapeutic area and knowing that it is essential to optimize the signal to noise ratio for efficiency and safety outcomes.

      We have led and will continue to lead the way for our clients, having successfully delivered ePRO and eObsRO-based labeling claims in phase 3 clinical trials using full DCT, hybrid and traditional clinical trial methodology.

      We are scientists who believe that we can make a difference in the way that clinical trials are conducted and that we can effectively help our clients achieve their efficacy and safety endpoints with confidence every step of the way.

      We have demonstrated that our DCT trial designs achieve an average of over 90% compliance and adherence and 88% retention. We believe this is a result of our multi-pronged approach. This approach includes design simplification, patient training, a centralized clinical site team, patient engagement strategies and technology-facilitated prompts. With this approach, SPRIM Health reduces patient burden, optimizes data quality and accuracy and maximizes the amount of data collected.

      Oncology and Rare Disease

      While there are obvious fits for so many types of clinical trials into hybrid and/or DCT designs, there are therapeutic areas which continue to have large unmet needs that have historically been accommodated through traditional brick and mortar site-based clinical trials. However, it is exactly these therapeutic areas, such as oncology and rare disease, that also stand to benefit the most from shifts in hybrid and/or DCT designs. The need for precision medicine in oncology trials has significantly increased as well as the need for obtaining patient information more regularly than a clinic visit. In oncology studies, there is a pressing need to relieve the burden on patients from frequent trips to drive to a clinic and wait for an appointment, when similar or better data could be obtained from the comfort of their own homes. Similarly, rare disease studies have been draining patient pools that are proximal to sites. Hybrid and DCT designs enable untapped patient pools to participate in a convenient and nonburdensome manner with greater accuracy in efficacy and safety outcomes. Frequently in rare disease, caregivers are needed as many of these studies occur in pediatric populations. Frequent in clinic visits can be stressful and burdensome to caregivers who are already exhausted from their day-to-day caregiver role who now need more absence from work to accommodate clinic visits. Much of the critically needed data can be obtained directly from patients and caregivers without them stepping outside of their house. Such strategies for oncology and rare disease can expedite enrollment, increase retention and provide more complete and accurate datasets.