What we asked: “Looking ahead to the next 5–10 years, what will be the key disruptors and/or what can be improved upon in the pharma industry?”
Response from: Bryan Spielman, Chief Growth Officer, Advarra
“The life sciences industry is burdened by lengthy, complex, and costly clinical trials with 70 percent of phase II and III trials delayed by an average of 16 months. Overall Study startup (SSU) is one of the biggest barriers to speedy clinical trials with nearly 80 percent of trials experiencing startup delays. These delays have a ripple effect through the entire trial – and why I believe that accelerating SSU would dramatically improve the drug development industry.
“Key bottlenecks in study start-up include regulatory approvals, technology set-up, budget and contract negotiations, and clinical trial participant enrolment. Here are two examples - 90 percent of phase II/III trials undergo at least one significant protocol amendment and most large pharma company trials average 3-4 per trial; and 86 percent of trials experience enrolment delays of between 1 and 8 months.
“Regulatory approvals can vary significantly across different regions, adding layers of complexity and potential delays. Regulatory harmonization and standardization are crucial for improving SSU efficiency. Efforts to harmonize regulatory requirements, such as those by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, can simplify and expedite regulatory approvals, while not compromising participant safety. Standardized processes and documentation reduce redundancy and enhance collaboration between sponsors, sites, and regulators.
“Technology can streamline processes, but according to a 2023 Advarra Study Activation Trend Report, over 50 percent of trial sites indicated that technology set-up was their most burdensome activity. Trial sponsors can leverage advanced software solutions and platforms installed at many clinical trial sites to help automate and streamline many SSU tasks. For example, site-based clinical trial management systems can enhance document management, regulatory compliance, and site communication. AI and machine learning can be leveraged to identify optimal trial sites and predict patient recruitment success, reducing the time and cost associated with these activities.
“Budget and contract negotiations are right behind technology as the next two most burdensome activities for sites, according to the same report. Negotiating contracts between sponsors and sites can be lengthy and complex. Each party has its own interests, risk tolerances, and expectations, which can lead to protracted discussions (i.e., intellectual property rights, publication rights, and data ownership are often contentious issues that require detailed negotiation). Similarly, budget negotiations between sponsors and sites can be prolonged because of mismatches between each party’s expectations – sponsors typically seek to minimize costs by using more generalized fair market value calculators, while sites want to secure adequate funding to cover their costs, which vary dramatically by geography and institution. Reimagining this process through a more collaborative relationship between trial sponsors and sites will be critical.
“Improving site relationships and patient engagement requires a strong and trusting bond between sponsors and sites. Sponsors should invest in building and maintaining these relationships through transparent communication, fair contract terms, and ongoing support. Training and support for site staff can improve their readiness and efficiency in initiating trials. Patient engagement is another critical factor. Innovative patient engagement strategies, including the use of technology solutions that better connect sites and patients can dramatically improve patient retention and satisfaction.
“Transforming the SSU process is critical to driving impactful, long-term improvements into drug development. By leveraging existing site technology, harmonizing regulations, fostering site relationships, and enhancing patient engagement, we can achieve significant gains in efficiency, cost-effectiveness, and innovation while not compromising safety. These changes will not only benefit sponsors and sites but ultimately lead to better health outcomes for patients worldwide.”
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