New cancer drugs take too much time and cost too much money to bring to market. The time to peak sales for products in development can be shortened by reducing the time to complete patient enrollment. This seems to be a simple concept, yet it is difficult to accomplish in the oncology sector.

Why is oncology clinical trial enrollment so difficult? The supply of adult cancer patients willing to participate in clinical trials remains stagnant at 3% to 5%. The low supply is matched with a high demand, with more than 850 cancer drugs and vaccines in development. Another difficulty is that cancer is not a single disease but many diseases, with the majority of cases classified as a rare disease. Breast cancer is not just breast cancer, it can be triple negative, Her2+, or metastatic. As cancers and drugs become more personalized, the challenge for finding and enrolling patients becomes even more daunting.

SHIFTING FROM A SITE- CENTRIC TO A PATIENT-CENTRIC ENROLLMENT MODEL
In order to reduce development time and costs in oncology clinical trials, the enrollment model needs to shift from a site-centric to a patient-centric approach. The traditional enrollment model identifies an investigator and then qualifies the investigator and the research site. Once the site is open to enrollment after weeks and months of regulatory review to obtain approval, then the site can begin to look for patients. This model works fine for conditions with large patient populations such as high blood pressure, osteoarthritis, and diabetes, but it is challenging in the field of oncology. A patient-centric approach looks for patients across a large number of study centers with sites opening once a patient is identified.

APPLYING THE JUST-IN-TIME PATIENT-CENTRIC APPROACH
In order to efficiently develop more personalized cancer treatments, it will be necessary to identify cancer patients with specific disease profiles and connect them to appropriate clinical trials at the point of care. Clinical trials must be made available at the local practice level for treatment of specific patients in a time frame that parallels the demands of need to treat, in days versus months.

With a patient-first research model, investigators commit to treating individual patients by only opening the trial when an interested and pre-identified patient presents. Value comes to patients, investigators, and study sponsors because personnel and research resources are focused on patient care and treatment, instead of on the administrative processes of site selection and regulatory documentation.

An efficient JIT (just-in-time) system (i.e. patient-first) requires clinical trial sponsors and investigators to prioritize resources and activities within the research process to make the clinical trial patient-centric. These adaptations involve review of standard operating procedures and adjustment of clinical workflow to align with the nuances of the JIT workflow. The steps are the same; they are simply prioritized around an individualized treatment opportunity for a specific patient.

In terms of efficiency, the JIT model utilizes a large group of investigators that are seeking interested, qualified patients. Therefore, JIT detects rare clinical events over a larger sample, essentially casting a broader net to find patients who meet the intent to treat the population of a given clinical trial.

COMPARISON OF A SITE-CENTRIC TO A PATIENT-CENTRIC MODEL
Research sponsors consistently express the need to enroll oncology clinical trials faster and more efficiently. The results of two clinical trials using the JIT approach in parallel with traditionally managed sites suggest that JIT accelerates enrollment with greater efficiency. All activated JIT centers enrolled patients within a few days of site initiation, whereas traditionally managed centers required months to enroll a first patient, and approximately 20% failed to enroll a single patient. Given a simultaneous start, the JIT method produced 70% greater overall enrollment and greater than double the rate of enrollment on a per site basis. The JIT patient-centric approach provides the most value in the community-based setting because it redirects the investment of clinical trial resources and costs into a leveraged system of accelerated enrollment.