A new patent has been issued to Moffitt Cancer Center for a computerized system that efficiently selects the right patient for the right clinical trial.

The newly patented system matches the registered patient’s own molecular profile – warehoused in a database of thousands of patient-donated biological tissue or tumor samples – to the molecular design of the drug aimed at targeting their disease at the molecular level, and do it quickly. The system promises to accelerate clinical trials and help shorten the time that it takes to get critically needed new drugs into the market.

Getting new drugs to market to fight cancer and other serious diseases requires, on average, 15 years. The drug development process is long and complex, but the three-phase clinical trials process – estimated to take up to half of those 15 years – is often the bottleneck in getting innovative drugs to the patients who need them.

Clinical trials, increasingly becoming more expensive, are also multifaceted. While patients may qualify for a clinical trial based on their age or stage of disease, they may not be, over the long term of the trial, the best candidates to test a drug. Adverse events, changes in a patient’s health status and the potential for a drug not being effective for them slow the process.

Although patients may have met the trial protocol’s criteria, the drug may not be right for them because their molecular profile is not a good match for the chemical and molecular properties of the drug. Because the concept of personalized medicine is selecting the right drug for the right patient, innovations have been needed to bring personalized medicine to reality. Personalizing the selection process for clinical trials is a vital step.

With the development of new and better ways to examine and understand a tumor’s molecular profile, matching the right patient to the right clinical trial becomes increasingly important. But handling the massive data evaluation necessary to accomplish this has been a stumbling block.

The newly patented computer system, Patent Number US 8,095,389 B2, or “Computer Systems and Methods for Selecting Patients for Clinical Trials,” is designed to surmount that problem.

The newly patented computer system is designed to:

• Select patients to clinical trials matching an individual’s/drug’s molecular profile
• Match patients to clinical trials by a patient’s disease/diagnosis
• Match patients to clinical trials by their symptoms
• Match patients to clinical trials by their demographic information and family history
• Track a clinical trial participant’s disease progression compared to drug efficacy

The newly patented computer system and associated products, such as operating system, software, interfaces and data retrieval system, improve clinical trial selection efficacy by making the patient selection process less random and more selective. The technology has the potential to refine clinical trials by eliminating bottlenecks, overhauling the selection process and shortening the timeline, ultimately bringing new drugs to market more efficiently.

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The percentage of U.S. citizens screened for cancer remains below national targets, with significant disparities among racial and ethnic populations, according to the first federal study to identify cancer screening disparities among Asian and Hispanic groups.

The report by the Centers for Disease Control and Prevention and the National Cancer Institute (NCI), part of the National Institutes of Health, was published in the CDC Morbidity and Mortality Weekly Report.

In 2010, breast cancer screening rates were 72.4 percent, below the Healthy People 2020 target of 81 percent; cervical cancer screening was 83 percent, below the target of 93 percent; and colorectal cancer screening was 58.6 percent, below the target of 70.5 percent, according to the study, “Cancer Screening in the United States – 2010.”

Screening rates for all three cancers were significantly lower among Asians (64.1 percent for breast cancer, 75.4 percent for cervical cancer, and 46.9 percent for colorectal cancer) compared to other groups, the study found.  Hispanics were less likely to be screened for cervical and colorectal cancer (78.7 percent and 46.5 percent, respectively) when compared to non-Hispanics (83.8 percent and 59.9 percent, respectively).

“It is troubling to see that not all Americans are getting the recommended cancer screenings and that disparities continue to persist for certain populations. Screening can find breast, cervical, and colorectal cancers at an early stage when treatment is more effective,” said Sallyann Coleman King, M.D., an epidemic intelligence service officer in CDC’s Division of Cancer Prevention and Control and lead author of the study.

“We must continue to monitor cancer screening rates to improve the health of all Americans.” Healthy People 2020 sets national objectives for improving the health of all Americans. Such objectives include the use of screening tests recommended by the United States Preventive Services Task Force for breast, cervical, and colorectal cancers.

Women aged 50-74 years should be screened for breast cancer with a mammogram every two years. Women who have been sexually active for three years or are aged 21-65 years should be screened for cervical cancer with a Pap test at least every three years.

Colorectal cancer screening is recommended for average-risk men and women aged 50-75 years, using high-sensitivity fecal occult blood test (FOBT), done at home every year; sigmoidoscopy every five years, with high-sensitivity FOBT every three years; or colonoscopy every 10 years.

To assess the use of currently recommended cancer screening tests by age, race, ethnicity, education, length of residence in the United States, and the source and financing of health care researchers analyzed data from the 2010 National Health Interview Survey, which tracks progress toward the achievement of  Healthy People 2020 objectives.

For the ethnic subgroups, Asians were classified as Chinese, Filipino, or other Asian and Hispanics as Puerto Rican, Mexican, Mexican-American, Central or South American, or other Hispanic.

Significant findings include:

• Screening rates for breast cancer remained relatively stable and varied no more than 3 percent over the period 2000-2010.
• From 2000-2010, colorectal cancer screening rates increased markedly for men and women, with the rate for women increasing slightly faster so that rates among both sexes were nearly identical (58.5 percent for men and 58.8 percent for women) in 2010.
• From 2000-2010, a small but statistically significant downward trend of 3.3 percent was observed in the rate of women who reported getting a Pap test within the last three years.
• Considerably lower breast, cervical, and colorectal cancer screening use was reported by those without any usual source of health care or health insurance.

The authors note that this study reinforces the need to identify and track cancer screening disparities. Additionally, the report provides guidance for the development programs to increase the use of screening tests in order to meet Healthy People 2020 targets and simultaneously reduce cancer morbidity and mortality.

“Healthy People objectives are important for monitoring progress toward reducing the burden of cancer in the United States. Our study points to the particular need for finding ways to increase the use of breast, cervical, and colorectal cancer screening tests among Asians, Hispanics, as well as adults who lack health insurance or a usual source of health care” said Carrie Klabunde, Ph.D., an epidemiologist in NCI’s Division of Cancer Control and Population Sciences and a co-author of the study.

According to the authors, the Affordable Care Act is expected to reduce financial barriers to care by expanding insurance coverage. Other efforts are needed such as developing systems that identify individuals eligible for cancer screening tests, actively encouraging the use of screening tests, and monitoring participation to improve screening rates, they say.

Image Courtesy of   http://www.flickr.com/photos/christianacare/

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The Congressional Men’s Health Caucus and its Prostate Cancer Task Force held its first public briefing today to hear expert testimony regarding the United States Preventive Service Task Force’s recent draft recommendation against the use of early screening tests for prostate cancer.

The Men’s Health Caucus and Prostate Task Force are headed up by Representatives Joe Baca, Jon Runyan, and Heath Shuler, who welcomed the featured speakers and spoke about their commitment to improving screening and treatment options for men with prostate cancer.

The briefing was co-sponsored by the Men’s Health Network, a health care non-profit working to reach men and their families with health prevention tools, screening programs, and educational materials. Prostate Cancer is the most common cancer for American men, one in six of whom will struggle with it during their lifetimes.

This year, more than 240,000 men in the U.S. will be diagnosed with prostate cancer. Mortality has declined nearly 40% since early detection through screening was introduced, but 33,000 men still die of prostate cancer annually. Now the United States Preventative Services Task Force (USPSTF) has issued draft recommendations which would dismantle early screening by telling health insurance policies to discontinue use of the prostate-specific antigen (PSA) test.

At today’s briefing members of Congress joined an expert panel to discuss what was missing from the USPSTF’s draft recommendations. Speakers included Dr. Chiledum Ahaghotu, Chief of Urology at Howard University Hospital and Dr. Tom Berger, Executive Director of the Veterans Health Council.

Representative John Barrow and Representative Tom Price, M.D., were featured speakers as well. Representatives Rodney Frelinghuysen and Gene Green rose to lend their support.

Dr. Chiledum Ahaghotu provided detailed background on the current state of prostate cancer, including treatment and screening options. He concluded by providing his views on the USPSTF’s recommendations, calling it a broad sweeping policy that does not work for individual men.

“We cannot stand by and let the USPSTF’s recommendation to drop early screening happen,” warned Dr. Tom Berger, Executive Director of the Veterans Health Council. “Doing so would be a major setback for Vietnam veterans who were exposed to Agent Orange. Veterans exposed to Agent Orange are twice as likely to suffer from prostate cancer as veterans who were not and are four times more likely to be diagnosed with prostate cancer that has spread beyond the prostate.”

Representative Barrow spoke from his experience as a prostate cancer survivor, saying, “The PSA test presents a great advantage for stopping prostate cancer and nipping it in the bud really, really early. The USPSTF recommendation discourages the screening on the theory that ignorance on the PSA is not only bliss, but actual good public policy.

To abandon early screening of prostate cancer is basically to ask men to play Russian roulette with their prostate cancer odds. You know the gun has six chambers; you want to know if there’s a bullet in it.”

Representative Tom Price, a retired physician, explained, “Because of the longevity of our lives, with the technology that’s now available for screening and for treatment, we have turned prostate cancer from one of those diseases that kill into one of those that can be cured. Ensuring that early screening is available to men is of vital importance to their health.

Medical decisions need to be between patients, their families, and their doctors.” ”I’d like to thank the representatives who spoke today for the leadership they have shown in the fight against prostate cancer,” said Men’s Health Network Vice President Scott Williams. ”Today’s briefing helps refocuses the conversation on what we can do right now to save lives.

Especially for men at high risk – like African Americans and Veterans exposed to Agent Orange – this is an issue that cannot wait.” ”This year alone, prostate cancer will claim the lives of more than 33,000 men in the United States,” said Rep. Heath Shuler (D-NC). “We believe this statistic is unacceptable and can be changed with better health education, detection, and preventative care.

We simply cannot wait to see this devastating disease destroy even more lives before taking action—the time is now to act.” ”One out of every six men will be diagnosed with prostate cancer at some point in his lifetime,” said Rep. Joe Baca.  “This is a serious disease that we must combat through better awareness and greater use of preventative measures.

I thank Reps. Shuler and Runyan for their bipartisan leadership on this important issue.  Working together, I am confident the Prostate Cancer Task Force will be a force for positive change in the health of men across the nation.”

“Prostate health is a major concern for men of all ages,” said Congressman Runyan. “Unfortunately, there are too many men who are ignoring their prostate’s health, and this must change. During my career in the NFL, I was very involved with charities to help with prostate cancer research, and I am glad I have been able to continue this work in Congress.

As a member of the Congressional Men’s Health Caucus, I am pleased to lend my support to this important cause.” Rep. Rodney Frelinghuysen rose to the podium to lend his support to prostate cancer screening, saying “This is not just about the man; it’s about the family.”

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