Challenges for Sites Doing Clinical Trials
By Tracy Christianson, CanceRx Clinical Research Consultant
From bench research to running trials to setting up new study site networks, I have observed a lot of changes in the clinical development sector.
These experiences brought me into contact with a lot of great people over the last few decades – from cancer patients willing to try new drugs, healthcare professionals of all kinds, as well as companies and researchers on the forefront of medicine.
One cannot be a part of any big, complex industry without noticing ways to make things better. And for me, building a CanceRx clinical research arm is an avenue to build a better way to pursue new cures for cancer.
We have several overarching goals.
- One big idea is, what incentives are driving the research? In normal practice, CROs are paid fees for services. Our incentives are different. Our metric will be based on selling rights to successful new products. Resources will only be spent on what’s working.
- Having a wholly owned CRO is another improvement. CROs are very expensive. Large costs go into sales and marketing to land more trials. We won’t need to invest in those activities and will instead put resources into making trials easier to run.
Plus, here five “pet-peeves” that we are making work better in order to encourage more clinics to offer clinical trials.
No. 1 – Duplicated Efforts
Medical staffing costs have skyrocketed since the pandemic, so wasting time is to be avoided. Meanwhile, clinical research is rife with duplication. It is resource intensive to enter data in many places, multiple times and in differing formats along with rechecking accuracy. Today, digitalization can transform tedious manual steps. Real time data and networked informatics will be more accurate and expedite trial management. Our central data platform will help hospitals and community cancer centers offer trials while also saving time, money and resources.
No. 2 – Too Many Site Visits
Clinical research associates (CRA) often call on study sites to review data, transfer electronic records and monitor protocols. CRAs need the host clinic to brief them, provide patient records and make sure they get project information they need. This may take a staff member out of the clinic for 8 hours per monitoring visit. The CanceRx CRO electronic data system will streamline these steps plus reduce the need for so many onsite visits.
No. 3 – Too Many Study Portals
When clinics run multiple trials, they must feed data to a variety of study portals. Each one is different. Any trial will involve recording research or regulatory data, randomization, drug retrieval and dispensing and tracking lab samples. There is no getting around it. To simplify admin, CanceRx will provide one eSource/EDC portal for multiple studies, which reduces the complexity of informatics while also easing training requirements for staff.
No. 4 – Payment Delays
Already medical centers and community clinics deal with slow compensation from payors. When study-sponsor red tape slows payments, this adds more burdens to the entire cancer center operation. The CanceRx CRO simplifies up-front contracting, pays on time and makes it easy to reconcile what items are paid, encouraging clinics to offer more trials.
No. 5 – Losing Focus On “Patients Come First”
A medical clinic’s primary role is to take care of patients. Study sponsors get this in theory, but they then present a site with a ton of paperwork and commitments that may divert focus from patients. Instead, clinical research should be additive to oncology care. The CanceRx CRO supports nurses, physicians and caregivers focusing on care while removing obstacles to giving patients more options.
A CRO Built By Clinicians For Clinicians And Their Patients
Each cancer patient has a unique challenge, but a common theme is the bond with their caregivers. Cancer patients do not have enough access to new treatment options. At CanceRx, we are putting together a portfolio of new treatments for trial to be available via a network of sites.
When “one and done” principal investigators offer research without knowhow, they may become discouraged after having a poor first experience. Our clinic-friendly support is a solution to reduce the cost and stress of offering clinical research. Our goal is to streamline new avenues for all of us to work together to cure cancer.