Project FrontRunner is an Oncology Center of Excellence (OCE) initiative that encourages sponsors to consider when it is appropriate to develop new cancer drugs for advanced or metastatic disease in an earlier clinical setting. Currently clinical trials are designed to include patients who have run out of treatment options and are in their late stage of disease.
Giving patients access to new treatment options at an earlier stage will improve the safety assessment of investigational drugs. Patients in this setting have a good performance status in comparison to the late stage setting where there can be ongoing and residual issues due to numerous lines of therapy prior to enrolling in a clinical trial.
Focusing on treatment options at an earlier stage would allow sponsors to consider randomized controlled trials and other study designs including the adaptive design given the larger patient pool. From here, sponsors would be able to compare the existing standard of care with the new treatment options. This would include opening more treatment arms in their study protocols and lead to innovative study designs which move away from the traditional 3+3 design.
The acceptance of this project provides the opportunity for additional treatment options and the improved survival of oncology patients.
Advancing oncology therapy development
Project FrontRunner is an initiative that will have tremendous impact on the way cancer research is conducted while also having the potential to unfold new cancer drug development.
This project has the potential to increase the patient pool which would not only have impact on study enrollment, but also help sponsors to test the safety of their investigational product by examining in patients with better performance status over a longer period of time. In turn, this will lead to a better understanding of the safety profile. This seems to be a win-win situation for sponsors and patients as it results in faster clinical development and earlier access to innovative solutions.
Key considerations during the transition process
The scope of Project FrontRunner is tied to other OCE initiatives and early adopters will be the ones who benefit the most. However, it is expected that not all oncology trials will change to include patients in the early stages of their disease or in advanced metastatic settings and there will continue to be clinical trials in late settings.
The sponsors will need to make changes in the way they do their pre-clinical research to support this initiative. This means that the investigational drugs that are about to begin their First in Human studies may not be able to make that switch immediately and there will be a lag period.
As previously mentioned, this initiative will take traction as time progresses and the oncology research space will see the impact of the changes accordingly.
Next steps in improving the standard of care
As a result of Project FrontRunner, oncology clinical trials will move away from traditional study designs to innovative study designs in an effort to support different situations. Currently, most sponsors are trying to get academic institutions on board since these institutions have the types of patients who are needed to support enrollment on the study. With this initiative, the sponsors will need to make some adjustments in terms of expectations about site selection. This would mean sponsors not only need to look for academic sites but also community oncology practices to get the enrollment of patients in their clinical trials. As a result, this will help community practices who are investing in the clinical research infrastructure and in the training of their staff to support their site participation in clinical trials. From the sponsor’s perspective, this can lead to getting more sites on board and increasing the cost to perform the clinical study. Considering the way oncology clinical trials are evolving regarding precision medicine, emphasis on genomics, and other nuances to develop individualized treatment option for patients, it will get harder to find patients if sponsors are not receptive to the idea of having more sites on board in order to enroll the required patient types in their clinical studies. There is a give and take in this situation and the sooner this is realized the better it will be for the sponsor, the study sites, and oncology clinical research.
About the Author
Syed Shah, MD, MPH, is currently working to support the ClinChoice team as Associate Director, Medical Monitoring. He has been in the industry for over 23 years and his experience in the field allows him to swiftly identify potential issues and operational challenges in study protocols, enabling him to develop innovative solutions that ensures seamless trial execution and compliance with regulatory standards.
ClinChoice is a leading global Contract Research Organization (CRO), with over 3700 clinical research professionals across North America, Asia, and Europe. For more than 27 years, ClinChoice has been providing high-quality contract research services to pharmaceutical, biotechnology, medical device, and consumer products clients, encompassing a broad range of services and therapeutic areas. ClinChoice offers cutting-edge, full-service solutions for Clinical Trials, Regulatory Affairs, Medical Device Safety, Toxicology, and Medical Affairs.