Explore the top five challenges facing oncology trials that contribute to the low 15% success rate. Learn about patient recruitment, trial design complexities, regulatory issues, data management, and financial constraints.
In the global fight against cancer, oncology trials play an important role in delivering potential new cures. Unfortunately, the likelihood of success of these trials is abysmally low with only. 15% of oncology trials ultimately succeeding from conception to completion. To shed light on the complexities and obstacles that are standing in our way of development, we have compiled a list of the top five challenges that contribute to this disheartening statistic.
Patient Inclusion and Exclusion
Barriers to recruitment: The single most notorious challenge is identifying and enrolling a sufficient number of eligible participants. This is especially the case with rare cancers or trials that require specific genetic profile data.
Retention — While getting the ones in the door is tough, incentivizing patients to stay throughout an entire trial can be equally as challenging. However, when you have a high dropout, it creates bias in results and becomes hard to interpret the outcomes.
Complex Trial Designs
Adaptive trial designs: these are more flexible and can deliver results quicker but tend to be more complex to operate and evaluate.
Studies driven by biomarkers: Useful as it may be in personalizing treatments, the inclusion of biomarkers for guiding therapy necessitates sophisticated technology and skills that can make the trial process cumbersome
Problems with Regulation and Compliances
Tight regulations: Navigating the regulatory landscape requires careful attention to detail and complete knowledge of global guidelines.
Compliance: Ensuring that ongoing trials can keep up with changing standards and dealing with the regulatory burden of delayed or cancelled trials due to a failure to meet these new standards could be tough.
Data Management and Analysis
Data volume and complexity: The vast amount of data generated from oncology trials must be properly stored, managed, and further analyzed to generate vital findings.
Diverse data source integration: Together with clinical data, the inclusion of genomic imaging and real-world data markedly increase the complexity of managing data.
Financial Constraints
Costs – Oncology trials are notoriously expensive and can be quietly draining in terms of extensive usage of financial resources for using of advanced technologies, patient recruitment and long-term follow-up.
Funding constraints: It remains difficult to raise enough funding from investors or grants, especially for young biotech companies.
Solutions and Strategies
The best of consulting firms makes it easier to manage such predicaments. For example, one key vertical is clinical research, in which biotech consulting firms are essential at every stage of the process — from trial design and regulatory compliance to patient recruitment and retention.
Conclusion
The process from oncology trial design to execution is full of twists and turns. BioBoston does a deep dive on why trials for cancers such low success rates had, from patient recruitment and retention to complex trial designs that lead to regulatory and compliance challenges, as well as data management and analysis issues compounded by financial constraints. Through careful planning and expert help from consulting firms help overcome these challenges leading to more successful oncology trials and consequently, better cancer treatments.
Reach out to BioBoston Consulting or visit our website now and see how we can guide you too!
