There are many questions that community oncology and society at large faces in regards to clinical research and clinical trials, with few solutions, offered. Therefore, I will address those questions or rather highlight them again with a solution that we have come up with at ICOP.

 

First, less than 3% of cancer patients are enrolled in clinical trials nationwide. In fact, that might be an overestimation. Bright spots to be highlighted may give a clue to potential solutions. For example, our Gabrail Cancer Center has, over the last 22 years, excelled where 90% of our cancer patients go on a clinical trial sometime during their cancer journey. In fact, up to 60% of our cancer patients get enrolled in two or more clinical trials, sequentially, of course. Here I have to stress the word clinical trials; it is phase I, II & III. Those numbers do not include post-marketing studies or chart reviews, and the like. 

 

Oncologists like ICOP members wondered how is that accomplished and how can such a model be franchised? I will explain shortly.

 

Second, a decade ago, it was estimated that the cost of developing a drug was close to or less than one billion dollars. Now that estimate is closer to three billion dollars. That cost hike far exceeds the inflation rate. That cost partly explains the skyrocketing cost of drugs to the consumer " patients." But the rising drug development cost can teleologically be linked to the mediocre number of patients available to be enrolled and, of course, to the number of investigators available. This brings us to the third observation.

 

Third, It has been estimated that only 13% of oncologists participate in meaningful clinical research. This might sound adequate, but that 13% is inclusive of both community-based as well as academics. We have to remember that almost 30% of oncologists are academics whose primary mission is supposed to be teaching and research, which means that even among academics, many do not participate, and that is expected since academia has become increasingly focused on revenue generation where most of them are financially incentivized to see more patients. I can dare say that even tenure potentially is linked to financial performance rather than research accomplishments. 

 

Fourth, the 13% mentioned predates the massive exodus of independent community oncology, thanks to hospital acquisition of practices, which must have shrunken the pool of potential investigators. Undoubtedly clinical research is cumbersome, time-consuming, and full of responsibilities and accountability. Yet, when hospitals contemplate involvement in pharma-sponsored clinical research, they make sure that the revenues generated through the hard work of physicians go to the hospital and subsidize their economic policies of more acquisitions and expansion. As a result, hospital-based oncologists are rarely incentivized to work harder in clinical research. Their financial compensation is, for the most part, RVU based. This has been one of the most ignored unspoken unintended consequences of the community oncology exodus. The pharmaceutical industry must be aware of this danger R&D is facing. Still, the marketing sector of pharma can't talk to the R&D divisions because of regulatory concerns and maybe because the marketing sector is myopic or both.

 

Enough said about the how and why we need solutions that have to be conceived by the innovative community oncologists and hopefully with pharma's contribution and collaboration. Since Gabrail Cancer Center (GCC) has taken the lead in establishing ICOP, it is natural and expected that we come up with solutions based on our 23 years of experience and success.

 

As a solo practice, GCC has a dedicated research division employing 16 FTEs with talent, zeal, and experience. Our success is manifested by the statistics mentioned above. We realize the challenges facing community practices building a tangible research program from scratch. It took GCC several years of evolution in building our robust program, let alone financial investment, trials, errors, and successes. Nevertheless, we have been where we wanted to be more than a decade ago. It would take a research virgin practice to be where GCC is at least ten years; we want to shrink that lead-time bias to less than two years with minimal investment in time and dollars.

 

Eight years ago, several oncology practices approached GCC asking for help and collaboration, those were practices who were already involved in clinical research, but they wanted to expand and quickly. We acted establishing the Sargon Research network, where we helped many of those practices get access to trials, train staff as needed, and even helped some in organizing their operations with great success. Realizing the need for education on how to do things successfully, we decided to have an annual Sargon Summit where investigators and their research staff attend, learn and share information on best practices and policies. The conference held annually at the Pro Football Hall of Fame in mid-August has been well attended by research sites, non-research sites, and the pharmaceutical industry. We ensured that financial barriers were eliminated, the Sargon Summit subsidizes the cost of travel and lodging, thanks to the pharma sponsors who carry that burden.

 

Sargon Research is focused only on those practices that already do research, the 13%. The remaining 87% were left alone, but now we have designed a solution for them and successfully so. This has been an unspoken advantage of joining ICOP. Simply stated, when we asked the research virgin practices to consider entering the arena, their logical and natural responses were: how many people should we hire? what qualifications should they have? How much facility space do we need? How do we get access to clinical trials? How do we know what a reasonable budget is? What is the upfront investment and when do we expect revenues to start coming, and when do we expect to break even at the least? And many more questions, all of which are reasonable and practical. In fact, many even asked if it is economically worthwhile, but of course, it is.

 

Realizing the challenges research virgin sites face, we have been there. We know what it takes in terms of trial, tribulation, patience, investment, and personnel needs. So we decided to develop a plan that is capitalistic in nature "Win, Win, Win." A scenario where practices win, patients win, and pharma wins. The plan is simple, we centralize 80% of the work at GCC while the research virgin practices carry the 20% load, not alone but with our help.  

 

This is how it is working:

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1. GCC does the regulatory work, which is cumbersome and talent hungry

2. We seek and offer clinical trials to the sites.

3. We do contract negotiation and budgeting.

4. We handle the IRB and other regulatory submissions.

5. We do data collections on patients enrolled in the clinical trials.

6. we at GCC also submit AEs and SAEs to the sponsors and IRB

7. we collect revenues from sponsors in a timely fashion and forward the fare share to the sites

8. Train the clinical staff virtually and in-person when needed.

9. We do the advertisement for the trials when needed or offered.

10. We help sites in methods of identifying patients to be screened, which has been a challenge for many sites that have been doing research. We know how to do that with a well-refined system that has proven optimal, if not the best, based on our performance in the last two decades.

11. We prepare sites for potential audits and sponsor reviews and monitoring visits.

12. Review the charts of potential patients remotely through telemetric technologies

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The duties of the sites are focused on:

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1. Adequately and appropriately screen patients with our help and assistance to ensure that inclusion and exclusion criteria are met and verified.

2. Proper documentation as required by good clinical practice following GCP guidelines.

3. Blood work including pharmacokinetics (PK) blood samples if required

4. Prompt and effective communication with sponsor and GCC staff

5. Attendance of investigators meeting and periodic virtual meetings with sponsor and CRO

 

We invite practices to explore this innovative method that is already liked and endorsed by Pharma and CROs. Community oncology practices can take advantage of this platform either independently or ICOP or preferably through joining ICOP.

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One last thing, we aspire that some practices through joining ICOP and Sargon Network will someday feel comfortable doing it A-Z independent of GCC or Sargon Research. 

 

We have no minimum time required to be part of the network. You join at will and leave at will.