Clinical Trials Take Flight: New Comprehensive Clinical Research Unit Supports Growing Program

 

The latest cancer drugs, vaccines, and other treatments all go through rigorous clinical research before they ever reach the broad patient population. In the last two decades, Kaiser Permanente Northern California (KPNC) clinicians and researchers have conducted a large body of clinical trial research in areas such as vaccine safety, HIV/AIDS, oncology, and in many other clinical specialties.

 

Currently, hundreds of clinical trials are being conducted in Northern California. The Permanente Medical Group (TPMG) physicians, based in KPNC medical centers, typically lead these trials. A growing number of clinicians are also getting involved in observational clinical research.

 

As clinical research has grown within the region, so too has the need for more centralized support, especially for solo clinician researchers embedded in medical centers. With that in mind, the Comprehensive Clinical Research Unit (CCRU) was launched in early 2008. The CCRU's major purpose is to improve the design, implementation, and reporting of clinical research studies--both interventional clinical trials and clinical trials--throughout KPNC, says Alan S. Go, MD, founding director. "Centralizing support for researchers at the individual and group levels helps to ensure that the research gets done efficiently and safely while taking some of the burden off the individual clinician."

 

Alan S. Go, MD; Nanette H. Hock, RN, MSN, FAHA; and Phenius V. Lathon, CCRCGo, who is currently working on his own clinical research studies of new investigational medications for stroke prevention in atrial fibrillation and secondary prevention of coronary heart disease, says the new research unit also provides an opportunity for more effective networking and collaboration among researchers and with external colleagues and research sponsors.

 

The CCRU offers operational support and consultation, expanded biostatistical and data analytic support, and online training on how to conduct clinical research studies. In early 2009, the CCRU launched a centralized research collaboration Web portal for any clinician or researcher who is considering doing a research project within KPNC.

 

"Researchers can enter information about their proposed research project and we will provide a rapid evaluation of their ideas and approach and then connect them with potential collaborators," says Go.

 

For example, he notes, a gastroenterologist in Santa Clara who wants to participate in a new clinical trial can request a project consultation, ask for pilot data with people at their facility, or possibly connect with other gastroenterologists in the region. Similarly, for a federal or industry sponsor looking for partners to help develop or enroll into clinical research studies, the CCRU can quickly connect that group with interested clinical experts within TPMG, says Go.

 

Oncology Clinical Trials

 

The CCRU will work closely with larger TPMG clinical trial groups such as Kaiser Permanente Oncology Clinical Trials (KPOCT), which began 20 years ago. KPOCT currently participates in more than 200 ongoing cancer studies, the majority of which are multicenter clinical trials. KPOCT, which does mostly Phase 2 and 3 clinical outcome trials, enrolls almost 400 Kaiser Permanente patients a year at KPNC's 26 medical centers.

 

"Support from Kaiser Permanente's Community Benefit Program and the Kaiser Foundation Research Institute have helped continuous expansion of the program since its start from a small group to one of the largest national programs," says Louis Fehrenbacher, MD, medical director of KPOCT and an oncologist at Kaiser Permanente Medical Center, Vallejo.

 

KPOCT has participated in several key practice-changing clinical trials in the last decade. Between 2000 and 2005, KPOCT was the highest enroller in the nation for a key study on the breast cancer drug Herceptin, which showed a dramatic decrease in the recurrence of HER2 positive breast cancer in women who were treated with the drug.

 

In addition to its renowned Herceptin trials, KPOCT has participated in clinical trials from the 1990s to the present. The trials looked at the effects of the drug Avastin for advanced colon, lung, and breast cancer, finding that the drug was effective at advanced stages of disease.

 

More recently, KPOCT researchers began a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial to determine if the combination of Avastin and Herceptin is effective in preventing breast cancer from recurring.

 

Studying Barriers to Enrollment

 

Carol P. Somkin, PhDWhile clinical research is critically important in improving cancer treatments, only 3 percent of cancer patients participate in clinical trials and researchers are eager to learn why. Carol P. Somkin, PhD, a research scientist and sociologist at the Division of Research (DOR), is working with Fehrenbacher on a study looking at barriers to patient enrollment in oncology trials and ways to increase participation. The study offers patients in the intervention group a telephone counseling session with a nurse educator who discusses clinical trials as one possible treatment option.

 

The goal of this intervention is to engage patients in talking about clinical trials with their oncologist. Doctor-patient interactions are likely to be more productive if the patient comes to the oncology visit prepared to ask questions about clinical trials.

 

"Most studies about barriers to clinical trials have asked people to respond to hypothetical scenarios, or attempted to increase recruitment with community advertising," Somkin says. "But using our electronic medical record, we can identify patients who are potentially eligible for ongoing clinical trials and tailor education specifically for them in real time to see what works."

 

Somkin, who has partnered with Fehrenbacher on several trials, says "You can't do this kind of study without a collaboration between physicians and researchers. Dr. Fehrenbacher has been instrumental in many ways, including helping to choose the trials we work on, getting buy-in from the oncologists, and providing crucial feedback on the intervention."

 

Vaccine Study Center

 

The Kaiser Permanente Vaccine Study Center was established in 1984 to conduct vaccine clinical trials and epidemiological research. Since then, there have been numerous large and pivotal clinical trials that have led to the licensure of many of the current vaccines used in children, including whooping cough and chicken pox, says Nicola P. Klein, MD, PhD, co-director of the center and research scientist at the DOR.

 

Bruce H. Fireman, MS and Nicola P. Klein, MD, PhDThe center has built a trial network of research staff at 20 KPNC pediatric clinics and, at any one time, has several active Phase 2 or 3 studies that involve thousands of children. The center also conducts trials in other Kaiser Permanente regions, including Colorado and Hawaii.

 

"A major focus of our current efforts is on the efficacy of meningitis vaccines for toddlers and infants, which is important because while meningitis peaks both in infancy and during young adulthood, the currently licensed vaccine is only available for those over the age of two years," says Klein.

 

Fast Track to Growth

 

In recent decades, the Division of Research has expanded from being a stellar epidemiology research group into new areas such as health policy, health services research, and genetics, says Go. The next major step will be to continue growing the DOR's expertise in and oversight of clinical trials, he says.

 

"The DOR brings a unique mix of methodological and content expertise and often adds complementary clinical expertise by partnering with TPMG chiefs groups across a wide range of medical and surgical specialties," adds Go. "We believe we will very quickly become a model of how you can do this on a larger scale in a community-based setting."