Improved diagnostic technologies, prevention methods and the advent of targeted therapeutic approaches have together contributed to lowering the mortality rate for the 10 most prevalent cancers.
This lower mortality rate has been recorded as more than 10 percent across most of Europe, Asia and North America. These innovations have driven more effective development of new cancer treatments while providing cancer patients unprecedented access to new therapies.
Dr. Brian Huber, Vice President of Therapeutic Areas, Drug Development and Consulting at ICON and Matthew Huber, a scientist focused on developing innovative oncology medicines, conducted a review highlighting how innovation in cancer clinical research puts an emphasis on patient centricity. Here we discuss the role that precision medicine and agile trial designs, such as adaptive trial designs and basket and umbrella trials, are playing in bringing a greater patient focus to oncology drug development.
Precision medicine in oncology
As our knowledge of genetics continues to advance, healthcare and treatment models are increasingly transitioning from a "one-size-fits-all" model to a precision medicine model, which aims to bring the right dose of the right drug, to the right patient, at the right time. In the area of oncology, this concept is applied by targeting cancer therapies against specific molecular lesions present in a tumour. Examining the genetic information present in a tumour, as well as how that genetic information is manifested as physical traits, can help clinicians avoid administering therapies to patients whose tumour may not harbour the characteristics needed for that therapy to be most effective. This approach has been proven to be more effective than the traditional histology-based approach, where all patients with a certain type of cancer would receive the same treatment.
Adaptive trial designs
Traditionally, clinical trials were available primarily for patients with little to no alternative treatment options. As precision medicine approaches become more popular, clinical trials are being integrated into comprehensive treatment plans for cancer patients. As these trends grow, clinical research protocols will need to be more flexible and patient-centric. Adaptive trial designs allow researchers to make protocol modifications as trials progress on the basis of how patients are responding to treatment. With this approach, the traditional clinical trial phases are less separated and more of a seamless continuum. This not only increases trial efficiency and effectiveness, but also allows for new scientific discovery to be taken into account to improve patient outcomes.
Basket and umbrella trials
In addition to adaptive trial designs, precision medicine approaches have driven the adoption of other innovative trial designs for developing targeted cancer treatments, such as basket and umbrella trials. Traditionally, cancer clinical trials recruited patients without considering their tumour histology. In basket trials, however, patients are recruited on the basis of the genetic makeup of their tumours regardless of the origin of their cancer. For example, a patient with melanoma and a patient with ovarian cancer may participate in the same research study if their tumours have the same genetic characteristics. This approach is particularly beneficial for patients with rare cancers who traditionally would have been excluded from clinical trials, giving them access to innovative targeted therapies. Moreover, basket trials are more efficient than evaluating different types of cancer separately, enabling researchers to bring novel therapies to patients more quickly.
The other type of trial design that has been advancing oncology clinical research is umbrella trials. In these trials, multiple targeted therapies are evaluated at the same time within a population of patients who have the same type of cancer. The genetic makeup of each patient’s tumour is assessed and therapies are administered from there on the basis of the genetic signature present. Again, this targeted approach allows for more efficient development of targeted therapies.
Conclusion
Precision medicine has created a paradigm shift in the way we diagnose, prevent and treat cancer. Beyond that, it has transformed the way we think about clinical research, resulting in the advent of adaptive, basket and umbrella trials. Harnessing these agile trial designs to move towards more patient-centric approaches within cancer drug development can be beneficial for patients, providers and drug development companies. To learn more about ICONs expertise in oncology clinical research, visit: ICONplc.com/oncology
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Digital Disruption
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
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The triad of trust: Navigating real-world healthcare data integration
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Leveraging historical data for use in rare disease trials
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Patient Centricity in Orphan Drug Development
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Advanced therapies for rare diseases
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Transforming Trials
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Increasing Complexity and Declining ROI in Drug Development
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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Survey results: How to engage healthcare decision-makers
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