Driving success and time-to-market in clinical drug developmentNEXT-GENERATION CLINICAL DEVELOPMENTwww.capgemini.comThe clinical drug development market is teeming with innovation, including cell and gene therapies, digital therapeutics, personalized medicine and biomarkers, and the integration of drugs and medical devices. However, despite these breakthroughs, many life sciences organizations are not able to fully capitalize on the advancements. A dramatic increase in the number of clinical trials, compounded by the intricacies of new therapeutic platforms, increased regulatory constraints, and intensified competition, has created unprecedented complexity for life sciences organizations. As a result, the drug development success rate remains stubbornly low, with just 10-15% of new treatments making it to market.In this article, we explore one key element of the development cycle—the clinical trial—and how the emergence of powerful new digital and data capabilities, as well as new trial designs, can help companies increase program efficiency, speed, and access, driving outcomes for both the business and patients.What is a next-generation clinical development?A next-generation clinical trial is a project that leverages advanced digital and data capabilities, including AI and generative AI, to manage multiple data sources, enable new design formats, and unlock new analysis methods.The value of next-generation clinical developmentReduction in time to market 2+ years>15% 20% to 50% 15% to 20% Probably of successDrug pipeline value increase Reduce cost2NEXT-GENERATION CLINICAL DEVELOPMENTBREAKING THROUGH THE CHALLENGES OF BREAKTHROUGH INNOVATIONS Despite the life sciences industry’s collective focus on bringing new, proven medicines to patients quickly, clinical trials remain a costly and time-consuming process. In today’s landscape, teams contend with the age-old industry challenges of recruitment and supply chain optimization as well as those stemming from new medical innovations, competition from emerging players and a exponential increase in data. Most clinical trial challenges relate to one of three main dimensions:• Only 5% of eligible patients have access to a clinical trial.• Recruiting a diverse set of patients remains a core challenge.• The average clinical trial lasts 6-10 years. • Digital tools are not being used to their full potential to enable end-to-end integration that would accelerate the entire process.• Overall cost for drug development is between $1-2 billion. • High cost is to large degree driven by low probability of success (PoS)AccessSpeedEffectiveness3NEXT-GENERATION CLINICAL DEVELOPMENTIn the world of clinical trials, so much is changing and yet one thing remains the same: to advance the healthcare industry and improve patient outcomes through research and innovation. To overcome the current challenges within the life sciences landscape, comp...
