Adapting clinical research models to a changing reimbursement environment
— Carrie Smith, RN

The landscape of oncology clinical research and new drug development has changed dramatically in the last decade. This change has not been an isolated phenomenon, it happened in concert with other changes in the health care delivery system. That change was in response to the alterations in the reimbursement to hospitals and medical oncologists as well as changes in the mission of the academic institutions and their financial stance and strategy.

In this review we will discuss the interactions between those changes, their impact on clinical research and the adaptations needed for all oncology service providers if they want to stay competitive or even survive in the business of cancer care delivery. I will outline what oncology practices should do if they want to enter this rapidly growing frontier of cancer care. The challenges and benefits of entering the arena of clinical research will be explored in order to help those who want to take on this field.

In the not-so-old days, research – both basic and clinical – predominantly fell in the sphere of academic institutions and large cancer centers. Generous grants from the federal government and pharmaceutical industry were there to be grabbed and used. Most academic physicians were able to substantially subsidize their salary through such grants.

However, since the late 1980s those grants started to diminish dropping by 75 percent in 1988 and later. For the professors to stay in their academic career they had to generate revenues through patient care. This resulted in increasing their focus on seeing more patients and augmenting revenues from the pharma industry through investigator-initiated trials, or specializing in more lucrative fields such as bone marrow transplantation. Consequently, many of the professors became de facto speakers on behalf of the drug companies; promoting their newly discovered drugs. Most academic institutions are now faced with issues of conflict-of-interest and the perceived ethical challenges of their physicians who rely on the pharma industry to subsidize their revenues.

The explosion in the number of anti-cancer agents under development and the quest of the pharma industry for profit generation has complicated the matter and created new challenges. Absolute reliance on academia to accrue patients to clinical trials is not an option anymore, time is money, the sooner a trial is completed the more money is generated and the longer the residual patent life of the drug under development, since patent life spans begin before a drug is marketed.

The pharmaceutical industry quickly adapted by expanding research sites in the community oncology practices with substantial success but not an optimal one. The conduct of clinical research is a challenge requiring dedication to the process, investment in a cohesive infrastructure of trained personnel and adequate space and equipment. The required, detailed and accurate documentation and accountability of the involved research staff can’t be underestimated. These alone explain the difficulty in identifying legitimate and competent sites capable of delivering accurate data on patients enrolled in a clinical trial.

The financial challenges to community oncology practices doing pharma sponsored clinical trials are undeniable and they are vastly different from the challenges faced when conducting research through the cooperative groups and CCOP. Many community oncology practices participate in NCI sponsored clinical trials where most of the regulatory work and data collection is done by the hospital research staff. The involvement of the physician and office staff is minimal and so is their share of the revenues generated from enrolling patients. Hospitals are happy with this scenario since their revenues from the clinical trials are more than adequate to cover their overhead expenses.

But the constant revenue decline for oncology practices from their infusion centers, especially the increasing meagerness of drug profitability, combined with the scientific curiosity and the eagerness to be part of the new drug discovery has pushed many of us to take on the pharmaceutical industry sponsored clinical trials. That is a welcome sign for the sponsors eager to complete their pivotal trials that will gain both logistically and financially, since the fixed overhead of the clinical research operation has to be offset by revenues generated from enrolling patients. Practices are paid for enrolling and retaining patients on a given trial. Just opening the trial generates little if any revenues; you have to enroll patients and keep them on the trial as planned if money is to come in. So what should practices do to make the process fiscally worthwhile?

The four key elements to the success of any clinical research program are; invest in building the infrastructure, budgeting, enrolling patients and collecting data (IBEC).

Any financial project requires up front money invested, but you don’t have to overspend from the outset. Successful practices usually start with a small operation consisting of one office room and one coordinator who will do the initial work. The expansion depends on the volume of patients enrolled and amount of work needed. Any additional expansion has to be addressed in light of work needed and revenues generated. Ten years ago we took on the task of clinical research, we delegated one of our nurses (myself ) to work on building the program from scratch on a part time basis while working in the infusion center. Ten years later we have 10 dedicated staff members who handle all aspects of clinical research including contracts and budgets, screening patients, scheduling the screening procedures and tests, administering the experimental agent, data collection, preparation of regulatory documents, and correspondence with the sponsors, CRO’s and the IRB’s. We had one small room as the research office, now we have a 4,000-square-foot facility for the research department. We launched the program with two trials, and in the last 10 years we have completed more than 160 trials and have 56 open and actively enrolling trials.

Time and experience teaches us how to budget any clinical trial. That can be arranged through a spreadsheet with the work needed throughout the trial built in the software. The number of visits, the intensity of the work needed and the type of trial determines what budget will make the trial worthwhile financially. The quality and volume of work performed in the past plays a key role in the acceptance of the budget submitted. If a site has a good performance history in terms of the number of patients enrolled in previous trials and the reputation of data quality, they will have an easy time obtaining a decent budget from the sponsor.

It would be redundant and potentially harmful if a trial is opened yet no patients are enrolled. It is obvious that the physicians have to be involved in deciding which clinical trial is to be opened at the site. It is they, the oncologists who must agree with the concept of the trial, determine if they have the potential patient population and the willingness to enroll. Most sponsors would like to know how many patients the site is potentially capable of enrolling; that number is an estimate but it has to be a conservative one since failure to deliver will compromise future trial availability to the site.

The commitment and enthusiasm of the oncologist holds the key to the success of a clinical trial. They know their patients and they are the ones who will identify those potential patients and discuss the option with them. Some research sites use the technique of chart review to identify patients for a specific trial and many sponsors and CRO’s encourage that inefficient method. To rely on the research staff alone to identify potential patients is a grave error, and if that is what the physicians want to do, they are better off not embarking on such a project.

Finally, data collection which like the rest of the operation is a team effort; it starts with the oncologist who must be detailed with the office notes, communicates exceedingly well with the research staff whenever there are adverse events, and certainly, instant communication when it comes to the serious adverse events (SAE). A sponsor would not accept a delay of more than 24 hours for an SAE report to the IRB and sponsor. The availability of paperless electronic medical records (EMR) can’t be underestimated in this regard. In my view, practices that don’t have an EMR up and running should delay the implementation of their planned research program until that goal is accomplished and until every staff member in the practice is fluent in the language of the EMR.

Clinical research is a challenge, but an exciting thing to do; there are more benefits to the patients and the staff than the challenges and difficulties faced in running the program. Practices who contemplate embarking on this challenge must take it very seriously and give it a priority. From our experience and that of others, operationally it should have some degree of autonomy and independence from the rest of the practice. It is critical that the director of research, the coordinator or the lead physician be the one in charge of hiring and training the staff. This administrative independency eliminates the layers of bureaucracy that can only hamper the work of an already tedious process.