As the clinical trial and life science industries evolve, methodologies around trial design, outcome selection, and quality assurance must advance with the industries. To achieve profitability and growth, sponsors must disrupt the status-quo and begin each trial with a few questions in mind, “Does our current approach allow us to increase the quality of our data, reduce cost, and decrease trial length while achieving a positive signal and meeting regulatory requirements?”
If the answers are “no”, then there is clearly work to be done. Fortunately, the current state of clinical assessment technology is poised to make innovation easier and more accessible than ever.
Here are three ways to achieve drug development acceleration without compromising what matters most, getting the maximum value out of your R&D dollar.
Leverage Technology to Increase Data Quality
From subject engagement and test administration to data capture and endpoint adjudication, aggregating and interpreting your data faster is essential to each phase of your trial. As data centrality grows, the ability to staff qualified raters, provide them with user-friendly assessment tools, and leverage sophisticated data capture technology will become an industry standard and critical to the success of any trial. An excellent example of real-world, advanced technology adoption is Pfizer’s first predictive modeling system. This system allows Pfizer to improve site quality, reinforce governance, and strengthen subject data by assessing study risk during the protocol design.
As digital solutions begin to emerge, state-of-art tools, like tablet-based assessments, provide sponsors and raters with the features they need to enhance subject engagement and trial efficacy. When researching the right eCOA for your protocol’s primary outcome, a few features to look for are real-time data capture, single platforms to house multiple assessments in multiple languages, workflows to improve protocol compliance, automated response capture and scoring, voice-over narration, and integrated security and compliance.
Increased sophistication of today’s eCOA platforms cannot only offer dramatic reduction in administration and scoring errors at the site level but ultimately provide improved data quality and a natural reduction in the rate of data review required. With these benefits, it is easy to see why next-generation digital solutions are a breath of fresh air in an industry desperate for shorter timelines and reduced costs.
Adopt Cost-efficient Solutions (without compromising subject data)
How many times has your clinical trial gone over budget? Can you count them on one hand? According to the discussion paper Innovation in Development, Regulatory Review, and Use of Clinical Advances, “Estimated costs for bringing a new drug to market through the research, development, and regulatory processes may be as much as $2.6 billion, a substantial increase over the previous decade.” It is no secret poor trial design, underqualified sites, and antiquated techniques are the recipe for expensive change orders and impending headaches.
Upfront, adopting modern technology and engaging subject matter experts might seem costly and out of reach. However, if your trial becomes stagnant and fails to meet deadlines, regulatory requirements or, even worse, continues to Phase III with compromised or invalid data, monetary mitigation will exceed every budget, every time. A clear solution to the undeniable rise in development costs is to regard expenditures like progressive technology and rigorous expert review as a necessary line item to successfully identify measures for improvement and foster clinically meaningful change.
Stay Ahead of Regulatory Demands
Despite the obvious benefits of cost-savings, superior data quality, and expedited reviews, the regulatory rigidity around mobile solutions is a natural hindrance to digital adoption. However, with the recent Innovative Initiative announcement by the FDA and the 21st Century Cures Act signed into law last year, acceptance of assessment digitization will become increasingly frequent.
To summarize the FDA perspective, the Cures Act is designed to enhance patient centricity and modernize clinical trial designs and clinical outcome assessments, in hopes of speeding up drug development and review.
With the FDA allocating $500 million to this initiative, mobile solutions are the instinctive next step when designing a trial and choosing a clinical outcome assessment. Thankfully, there are already a variety of FDA 21 CFR part 11 compliant applications and platforms in the marketplace for clinical and cognitive disorders.
Continuous Innovation Drives Acceleration
Acceleration of drug development is not only industry critical, it is paramount to our primary mission to deliver improved global healthcare outcomes. For this initiative to be successful, sponsors must engage continuous innovation in every aspect of the clinical trial. While technology provides the tools for reducing the noise, alleviating the financial burden, and shrinking project timelines, true innovation can only take place through a paradigm shift in our approach to clinical trial methodology.