The Woodlands, Texas -- October 23, 2009-- According to a national poll of oncologists and clinical research professionals, there is a high level of optimism about the potential of clinical trials for personalized medicine, in spite of concerns that cost and reimbursement currently present barriers to both treatment and research. Fifty eight percent reported being optimistic about the future of clinical trials in the United States, while 25 percent reported being either ambivalent or unsure. Only 17 percent consider themselves pessimistic. 

Over half of respondents (53%) said they think that recruiting patients to clinical trials for targeted therapies will be less difficult than large-scale randomized trials of more traditional cytotoxic therapies.

As part of an ongoing effort to give voice to oncologists and associated professionals, US Oncology conducts bi-annual pulse surveys on topics of interest to the oncology world. Stephen Smith, vice president and general manager of US Oncology Research and Personalized Science Services, was eager to explore the perceived challenges and opportunities associated with research in personalized medicine.

“Everyone believes that personalized medicine is the future of cancer treatment, but we can’t get there without research. It’s vitally important that we know how professionals on the front lines of cancer research feel about our progress -- both the barriers and success factors, and ultimately the opportunities,” said Smith.

Sponsored by US Oncology, and conducted by KJT Group, the survey polled a mix of oncologists (67%) with specialties in the areas of medical, radiation, surgical and hematology, and clinical research professionals (33%), including trial coordinators, study managers and physician/investigators. The survey sought to quantify personalized medicine trends in treatment and research, while examining the impact of regulatory policies and reimbursement on clinical trials. Respondents were also queried on the quality of clinical research, patient accrual success, and specific ways to reduce the barriers to patient participation. 

Personalized Medicine
Survey respondents estimate that forty percent of oncology patients are treated with a personalized medicine approach and rate the top benefits of such treatment as follows:

o Enables the selection of optimal therapy and reduces trial and error prescribing
o 80.0% rate as very important (6 or 7 on a scale of 7)
o Improves the selection of targets for drug discovery
o 76.6% rate as very important (6 or 7 on a scale of 7)
o Reduces adverse drug reactions
o 72.3% rate as very important” (6 or 7 on a scale of 7)

Currently, the most utilized personalized medicine techniques include: gene expression profiles (mRNA) (69%), protein expression profiles (51%), and DNA methylation markers/profiles (27%).  When asked to identify the biomarkers most likely to garner focus in research and practice over the next three years, the majority of respondents expect to continue using gene and protein expression profiles but expect an increased focus on microRNA marker/profiles (expected increase from 21% to 43%). Respondents also predicted increased focus over the next three years on histone methylation markers (11% to 22%) and histone acetylation markers (7% to 17%).

The most common tumor types treated with a personalized medicine approach are breast (70%), colorectal, (51%), lung (44%), hematologic (40%) and prostate (23%).     

When asked to identify factors that would drive the advancement of personalized medicine, over half cited evidence-based medicine, and one-third cited physicians as the main factor. The challenges to practicing personalized medicine were less clear cut. Respondents cited both internal and external factors. The internal factors were: difficulty associating specific cancer types with molecular markers in a comprehensive manner (64%) and a lack of biomarkers for stratifying patient populations (52%). External factors included third party payers (62%) and the lack of clarity in future regulatory or legal requirements (51%).

The Impact of Policy and Cost on Clinical Research
Although not universal, respondents reported that the following policy initiatives could promote personalized medicine, by rating them as very effective (6 or 7 on a scale of 7).

• Government subsidization of clinical trials for personalized medicine (54%)
• Industry collaboration on the development of personalized medicine (53%)
• R&D tax credits for the biotech/pharma industry to encourage personalized medicine development efforts (50%)
• National patient databases for matching patients with appropriate clinical trials (49%)

Cost/reimbursement alignment in oncologists’ and clinical trial professionals’ decisions to “promote” personalized medicine was cited as a very important (rated 6 or 7 on a scale of 7) factor for 55% of respondents. Eighty-five percent of respondents indicated that cost/reimbursement alignment affects their ability to treat patients with a personalized medicine approach at least some of the time (rated 3, 4 or 5 on a scale of 5). When it does affect their ability to treat patients, most respondents (82%) said it impacted their ability to provide standard of care.

“Oncologists want to offer clinical trials to their patients that involve standard of care treatment, plus or minus the investigational agent,” says Stephen Jones, M.D., medical director for US Oncology Research and a practicing medical oncologist and director of breast cancer research for Texas Oncology - Baylor-Sammons Cancer Center in Dallas, a US Oncology affiliate. “Patients always receive the standard of care treatment as a default, but many are finding that by participating in clinical trials some payers are denying payment for the accompanying standard of care. That refusal puts an immediate halt to research participation for most patients. They obviously can’t forgo standard of care and they often cannot afford to pay for it themselves.”

The survey also assessed oncologist and clinical research professionals’ awareness of the Institute of Medicine recommendations of HIPAA modification to eliminate barriers to research, and support of Orphan Drug status for personalized medicine. Awareness was low, while support was high, respectively.  

Patient Participation
When it came to increasing patient participation in clinical trials, more than half of respondents cited mandated health plan coverage as the single most important factor. Half of respondents reported patient recruitment for clinical trials as most successful in academic medical centers. Of those, twenty four percent said they think it’s due to patient acceptance in that setting and twenty percent because of a large patient population. Of the eighteen percent who cited large private practices as having the most success with patient recruitment, most credited a large patient population and a trusting relationship with the physician. Of the fourteen percent who cited success in for-profit organizations devoted to clinical trials, most thought it was due to a singular focus on research.

Clinical Research Quality and Future
The majority (83%) of respondents reported that regulatory red tape is to blame for the lengthy clinical trial approval process. Other reasons include: inefficiency on the part of the initiating organization (51%) and lack of funding (44%).  When thinking about the clinical trial review process, more than half of respondents strongly agreed (6 or 7 on a 7-point scale) that it is critical for reviewers to assess whether the resources consumed by the trial are scientifically justified.  On the other hand, only a small percentage (14%) agreed there is a mechanism in place currently to distinguish between low and high quality clinical trials. 

Study Methodology
KJT Group conducted this survey among a cross section of U.S.-based medical, radiation, surgical oncologists, hematologists, medical directors and clinical trial professionals.  Responding oncologists report the majority of clinical trials conducted at their practice per month are Phase II and Phase III.  With a total sample size of 299 (199 oncologists and hematologists and 100 clinical trial professionals), the overall margin of error at the 95 percent confidence level is approximately +/- 6 percent.  The quantitative survey was blinded (no sponsor identified) and interviews were collected from June 29 to July 6, 2009. Respondents were screened for their experience in clinical research.  The full survey instrument and findings not included in this release are available upon request.

About US Oncology
US Oncology, Inc., headquartered in The Woodlands, Texas, works closely with physicians, manufacturers, and payers to identify and deliver innovative services that enhance patient access to advanced cancer care. US Oncology supports one of the nation’s foremost cancer treatment and research networks, accelerating the availability and use of evidence-based medicine and shared best practices.

US Oncology uses its expertise to support every aspect of the cancer care delivery system—from drug development to distribution and outcomes measurement—enabling the company to help increase the efficiency and safety of cancer care. According to the company’s last quarterly earnings report, US Oncology is affiliated with 1,236 physicians operating in 476 locations, including 94 radiation oncology facilities in 39 states. For more information, visit the company’s Web site, www.usoncology.com.

About KJT Group
KJT Group, headquartered in Honeoye Falls, NY, is a growing research and consulting firm focusing on the health services research market. Founded by Dr. Kenneth J. Tomaszewski, KJT Group blends academic rigor and practical market research techniques.  Areas of specialization include market analysis and health outcomes research. For more information, visit www.kjtgroup.com.

Media Contacts:
Jennifer Horspool
(832) 601-6151
Jennifer.Horspool@usoncology.com

Lisa Henderson 
(813) 775-6208 
Lisa.Henderson@hillandknowlton.com

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