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