The Studion Way to Build a Better Clinical Trial Study

Patient centricity is a key buzzword in the life sciences industry for good reason. In clinical development, patient centricity means understanding the wants and needs of patients and keeping them at the center of all decisions around clinical trial design and execution. There has been an increased effort recently to leverage data, advocacy groups, and patients in the design of clinical protocols. The focus has been on understanding the patient profile to maximize recruitment through appropriate inclusion/exclusion criteria when selecting trial participants. 

This is a critical step, and resources are put into understanding the treatment populations through real-world data reviews and the development of digital twins. While this can provide a better picture of the clinical challenges, from concomitant medications to comorbidities and more, we in the life sciences industry need to better address how to engage and retain our patient population during each clinical trial.

Patient recruitment and retention remain the biggest and most costly challenges in clinical development today.

We must not only understand where to find patients that meet clinical protocol requirements, but we must also understand the needs of the patients who choose to participate in clinical trials in order to effectively engage them throughout. Understanding their daily challenges and what they consider convenient engagement can improve recruitment, engagement, and retention. For virtual and hybrid trials, this is particularly important since data collection depends on patient compliance. 

It is not uncommon for clinical protocols to be written and submitted for regulatory review independent of operational planning for the clinical trial. This frequently causes the following issues: 

• When this process occurs later in the clinical development, it puts pressure on the clinical operations teams, CROs, and clinical technology providers to deliver, and time becomes the driving force rather than the patient’s best experience. 

• Often, digital tools and systems are not considered during the protocol design. If using an electronic clinical outcome assessment (ECOA) is brought up as an option, teams need the time to assess the impact of the protocol’s design on that technology. 

• It may be unclear whether the clinical protocol will support an effective digital experience, and, when this step is done close to when or even after the clinical protocol is finalized, there may be constraints in the clinical design that make deploying digital solutions difficult. 

• Evaluating various vendors is complicated, as is understanding their approaches to design, implementation, and activation. 

All of these things result in increased costs, time pressures, and compromises. Throughout the industry, there’s frustration that technology adds more complexity and cost than benefits in improving the speed and cost of drug development. As reported in a 2018 Tufts Impact Report, "Clinical data technologies have been introduced to drive efficiency and quality, but overall timelines and cost have increased along with the volume of data and complexity.“ 

At Studion, with over 10 years of experience in creating more than 1,200 clinical trial solutions, we understand these challenges and are equipped to meet them.

We are technology agnostic and 100% focused on designing the best digital experiences to engage and empower patients and collect high-quality data that deliver meaningful outcomes. We imagine a scenario in which the clinical protocol is written alongside the digital protocol, resulting in the best science and the best operational designs to maximize patient engagement and thus lead to better outcomes. 

This paradigm shift would empower life sciences organizations to better define the overall patient experience. It would also result in a standard digital design that could be shared with technology providers to improve the partner selection process and the overall implementation timeline. With an average of 68 days to design and implement a trial database, and an average of 5–7 unique databases per trial, per the 2018 Tufts Impact Report, timelines can easily balloon, and work can get caught in a bottleneck. But we believe that if organizations can think through and plan for each clinical trial while working through the science and keeping their patients in mind, they might have a better solution at hand when the time comes to conduct that trial.

We believe that to achieve true patient centricity, the full patient experience from clinical design through execution needs to be considered. Tethering the clinical and digital designs has the opportunity to truly unlock the potential of technology to be the innovation the industry is seeking. Patients want to be actively engaged in finding treatments for themselves and others, and we can support that desire. Incorporating these elements into their personal experience drives compliance and data quality, which impacts the approval of new treatments for a healthier world. That’s why we at Studion are focused on enabling these meaningful digital experiences.

eClinical data volume and diversity pose increasing challenges, delays. Tufts Impact Report. Volume 20 Number 1 January/February 2018