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Teaming up with a staffing partner can help companies find the right CRA for their trial.
With cancer estimated to be the leading killer of Americans aged 55 and older, and the aging baby-boomer population reaching 60 this year, the call for life-saving drugs is stronger than ever. It has been estimated that 570,000 people were expected to die from cancer in 2005.1 This has led to an influx of pharmaceutical companies entering the field in the quest for cancer curing drugs, which in turn has made oncology one of the fastest growing clinical monitoring sectors. The generic cancer market alone is expected to grow at an impressive compound annual rate of 23.5% from 2004 to 2014.2
The nation's changing demographics also play a role in oncology trial growth. Studies from the Centers for Disease Control and Prevention show that 76% of all cancers diagnosed are found in people 55 and older. So, as the baby boomers approach 60, the instances of cancer in the United States are expected to increase dramatically. Also, while only one in 12 men and women will develop cancer between the ages of 40 to 59, the instances jump to one in three men and one in four women between ages 60 to 79.1
In addition to such rapid growth and interest from companies in oncology, other parties are taking a serious interest as well. Coverage of patients' rights issues has become a fixture in the media and has fueled the already politically charged environment. As a result, the FDA is more watchful than ever during these trials. With the creation of the Drug Oversight Safety Board in February 2005, the FDA will oversee the management of important drug safety issues within the Center for Drug Evaluation and Research (CDER).
The FDA will also increase the transparency of its decision-making process by establishing and expanding communication channels to provide targeted drug safety information to the public. These channels will be used to help ensure that established and emerging drug safety data are quickly available in an easily accessible form. The increased openness will enable patients and their health care professionals to make better-informed decisions about individual treatment options. As the FDA develops these communications formats, it will also solicit public input on how to manage potential concerns associated with disseminating emerging information prior to regulatory action.3
With the recent expansion in the number, complexity, and longevity of oncology trials, companies are requiring greater skill sets and more experience from the individuals who are responsible for the clinical trial monitoring. The increased scrutiny placed on the clinical trials has resulted in increased responsibilities for the clinical research associate (CRA). Pharmaceutical companies must take a more specialized approach in staffing these highly skilled and trained professionals for oncology trials. What's more, due in part to their long-term nature, the complexity of the disease, and increase in cancer biomarkers, oncology trials collect more data points than any other trial type.
CRAs must fill a checks and balances role in oncology trials, ensuring that the investigator follows proper protocol in defining how the drug affects the patient. For example, an investigator may report that a patient responded positively to a particular drug. However, that determination may have been made through criteria that do not match those set out by the protocol for the trial. In that case, the CRA must note any deviations with proper documentation, address them with the investigator to understand his/her rationale, and initiate any corrective actions—actions that may ultimately result in removing the patient from the clinical trial. To ensure that the investigator's interpretation is accurate within the constraints of the protocol, the oncology CRA must be able to understand and interpret radiology and lab reports, imaging reports, blood counts, and levels of biomarkers—they are not simply reading the data in the case report, as with other monitoring. This interpretation requires that the CRA possesses complex math skills to calculate exposure to different types of radiation and chemotherapeutic agents.
Still, this can be a delicate issue to manage if the investigator feels the patient is benefiting from the drug. Ethical issues are often raised, but ultimately the CRA and investigator must follow protocol. Such exchanges require an oncology CRA to be assertive as well as confident in his or her knowledge of the trial's protocol and therapeutic area.
Another area that requires close attention on the part of the CRA is making sure patients are properly enrolled in the trial—verifying the inclusion/exclusion (I/E) criteria when an investigator enrolls a patient in a study. While CRAs have to do this for all types of studies, knowing the process and performing the complex calculations to determine if a patient is appropriately enrolled is especially challenging in oncology trials given the number and complexity of I/E criteria that must be verified. The patient's charts are often very large, complex, and sometimes incomplete, which makes looking for the data to verify these parameters difficult. Often the I/E criteria require patients to have failed certain drug regimens or to have been exposed to a certain amount of other drugs. Due to complex dosing (such as per body surface area), CRAs must have strong math skills and radiation and chemotherapy knowledge—knowing the current regimens for different cancers. Gaining access to this information, calculating dosages, and verifying the drug exposure is particularly difficult.
Confident math skills also come into play when performing appropriate calculations to determine the impact of the drug on the tumor size. While it is the physician who makes the determination about whether the cancer is in remission or progression, the CRA must be able to verify the doctor's assessment and discuss any deviations—another checks and balances role.
While experience will vary from person to person, a clinical background (e.g., in nursing or pharmacy) is preferred for oncology CRAs. An oncology certified nurse (OCN) is often considered the best person to train for a CRA position because he or she already has the clinical and technical background and will only need to learn the regulatory aspects of the role.
Perhaps one of the most challenging aspects of oncology trials is that of appropriately enrolling patients. Oncology is a sensitive area because of the serious nature of the disease, and patients and families often want to explore every option possible. Families often pressure nurses and investigators to enroll patients in drug studies whether it is appropriate or not. CRAs must have a "heads-up" personality and well-honed people management skills to withstand possible subsequent pressure from nurses and investigators. It is also necessary for CRAs to build good relationships with clinical research staff, which will enable them to have discussions when complex issues arise. This is where a technical background becomes critical; it gives CRAs the confidence needed to address specific questions regarding the protocol, I/E criteria, reporting processes, and other issues. A good relationship with an investigator also makes it easier for a CRA to train and educate the investigator's staff during long-term studies.
The length of oncology trials poses another challenge for CRAs in that patients must be studied progressively through the end of their lives. The inevitable negative of losing someone to whom they have become attached may steer some CRAs away from oncology trials. On the other hand, the ideal oncology CRA is one who finds it rewarding to work on a project that may ultimately increase someone's chances of survival.
Pharmaceutical companies are beginning to understand that utilizing a staffing firm—whose sole focus is finding the right candidate match—is a more efficient and cost-effective way to approach specialized staffing. Choosing the right staffing partner can significantly decrease the number of challenges that pharmaceutical companies face while ensuring the success of oncology trials. Because of the long-term nature of these trials, pharmaceutical companies should choose a provider with strong retention programs, as turnover can put study results at serious risk. Turnover also has a negative impact on investigator relationships and performance because having a new CRA with different styles requires additional time and effort from the clinical site research personnel. Additionally, relationships are difficult to build when new CRAs are introduced into the clinical site.
Choosing a Staffing Firm
While CROs assign their staff to a particular study, staffing firms specifically recruit CRAs with oncology experience who have chosen to monitor a specific trial. This increased level of interest often results in a better work output. When CRAs choose the work that they want to be involved in, they are more dedicated and invested, which results in increased retention and quality of work.
Combating the national shortage of oncology-trained monitors has become a focus for staffing firms. The ability to locate resources in tough geographic markets or train oncology clinical professionals to become CRAs in those markets is a huge benefit to pharmaceutical companies that staffing firms can provide. Locating qualified individuals in specific geographic markets results in decreased travel to the sites, decreased travel costs, increased CRA retention, and improved response time to investigators' needs. Staffing firms also provide value-added services, such as additional training, professional development, and a high level of oversight to ensure quality performance.
Key to the success of any oncology trial is the high degree of joint ownership between the staffing provider and the client company. Pharmaceutical companies must define their needs and find a staffing partner that best fits with their corporate culture and has a proven track record of recruiting, hiring, training, and retaining the clinical talent needed for the full life of the project. By working together to ensure accuracy, quality, and protocol adherence, the end result will be a mutually beneficial relationship built on trust.
1. Centers for Disease Control and Prevention, United States Cancer Statistics: 2002 Incidence and Mortality (CDC, Altanta, GA, 2005).
2. Datamonitor, "Commercial Insight: Generic Cancer Market—New Legislation and a Wave of Patent Expiries to Transform the Market," 14 February 2006.
3. Food and Drug Administration, FDA Improvements in Drug Safety Monitoring (FDA, Rockville, MD, 15 February 2006).
Kelli Henry is associate director of clinical operations with Kforce Clinical Research, a division of Kforce Inc., 15260 Ventura Boulevard, Suite 980, Sherman Oaks, CA 91403, email: firstname.lastname@example.org, www.kforce.com