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Science
Cancer Clinical Trials:
The Future Is Now
According to the James Cancer Hospital at Ohio State University, more than one of every four employees in a typical company is likely to be diagnosed with cancer during their work lives. A 1997 study by Analysis Group/Economics confirms the costs: In a major firm with more than 100,000 employees, those with cancer cost the business, on average, five times as much in healthcare and disability as those without the disease. This adds up to some 6.5 percent of the corporation's total healthcare expenditures.
What can corporate America do to ensure that its workforce is getting access to state-of-the-art cancer care? The answer may lie in cancer clinical trials. The startling fact is that hundreds of new cancer therapies offering the opportunity for patients to receive a new and potentially more effective treatment sit waiting. The reason? Cancer patients don't know about them. Less than five percent of cancer patients participate in clinical trials. A recent Harris InteractiveSM survey found that 85 percent of cancer patients who responded were unaware that clinical trials were even a treatment option.
"Right now, there are nearly 400 new treatments out there ready to be tested," says Robert L. Comis, M.D., president of the Coalition of National Cancer Cooperative Groups, the only national non-profit organization founded to improve the survival and quality of life of cancer patients through increased participation in cancer clinical trials. "If we're stuck at three to five percent of adult patients participating in clinical trials, it will be years before these new treatments are tested for effectiveness and become generally available." Therefore, increased participation in clinical trials has never been more critical.
In clinical trials, cancer patients receive either the current best-known treatment or the opportunity for a new one. Unlike in other drug trials, in cancer treatment trials, placebos are rarely used, and they are never used in place of the best existing treatment for a given cancer.
Corporate America can play a significant role in helping to deliver new therapies to the public by educating employees and customers about cancer clinical trials and helping to correct the misconceptions that are barriers to participation. A few FORTUNE 500® companies have already moved in this direction. "General Motors is at the forefront of companies battling cancer, and that goes beyond just financial support," says Marcus G. Wilson, M.D., corporate medical director for GM. "For example, we have partnered with the National Surgical Adjuvant Breast and Bowel Project (NSABP), to inform our female employees about the STAR Trial, a breast cancer preventive trial, so they have the opportunity to make more informed decisions about their own healthcare."
Corporations can also work with their insurance providers so that employees are covered for clinical trial treatment. Recent studies by Memorial Sloan-Kettering, the Mayo Clinic and Kaiser Permanente have documented the fact that a cancer clinical trial may actually cost less for certain types of tumors than other treatment options (see chart S8). Some major insurers already cover the costs of cancer clinical trials, and several states, including California, Maryland, Louisiana and Arizona, have passed legislation that requires insurance companies to pay for the routine care costs of cancer clinical trials. And for those 65 or older, these costs are now covered by Medicare.
"Cancer is a disease that affects us all—in our personal and civic lives, our businesses, our national well-being," says E. Joseph Alberding, M.D., vice president of Global Medical Affairs at the Kellogg Company, a self-insurer. "At Kellogg, we want to improve the lives of cancer patients and caregivers. Therefore, we are investing in cancer education and we cover employee costs of federally approved clinical trials. It is an investment in our own future."
What are Cancer Clinical Trials?
Before a new preventive or therapeutic approach is made available to the public, it must undergo a series of clinical trials. Clinical trials are conducted in physician practices nationwide by cooperative groups, the pharmaceutical industry, cancer centers and other academic and hospital centers. Studies sponsored by federal agencies like the National Cancer Institute (NCI) and the FDA are strictly monitored and carefully evaluated. They test a treatment's safety and effectiveness for a particular type of cancer.
Three phases of a clinical trial must be successfully completed before the FDA grants approval for marketing. Phase I establishes dosage and measures toxicity; Phase II evaluates whether there is a positive effect against the cancer; and Phase III compares the new treatment with the current standard of care. Each phase of the trial requires a larger number of participants, ranging from as few as a dozen to several thousands.
Dr. Comis describes the painstaking search for new treatments: "Of the thousands of promising laboratory compounds discovered, only a fraction pass the milestones for clinical develop-ment. It is these most promising agents which are tested in clinical trials." Presently, it takes nearly 14 years to bring an agent out of the lab and into the pharmacy. Since clinical trials are often the most important and time-consuming step in this process, increased enrollment can shorten the timetable significantly.
Most often, Phase III trials are randomized, that is, patients have an equal chance of receiving the new approach or the existing standard of care. Ellen Stovall, a 29-year cancer survivor and founder of the National Coalition for Cancer Survivorship, says, "In large, randomized clinical trials, we are comparing the current best treatment for this disease against another treatment that we believe, based on the results of earlier studies, will work even better. So you are really getting optimal care when you enroll in Phase III clinical trials."
Cancer clinical trials offer hope for many. However, because answers for very specific questions are being sought, not everyone is eligible, and there is no assurance that every participant will be receptive to the treatment or that the treatment itself will live up to its promise. Nevertheless, those who are eligible for a clinical trial and responsive to the new therapy may benefit from it before it becomes generally available.
Progress in Cancer Treatment
As a nation, we spend billions of dollars a year in basic research. Since 1971, when President Richard Nixon made a cure for cancer a national priority, the NCI alone has invested $29 billion in research, enabling scientists to understand the complex biology of the disease. Significant progress has been made and, today, one out of two patients in the U.S. will survive cancer. These 8.6 million survivors represent a significant increase in the rate of survival from the 1960s, when the average was one in three. New treatments resulting from cancer clinical trials can help further increase this rate.
Many advances have been due to the work of the nation's NCI-funded cancer cooperative groups. Michael J. O'Connell, M.D., of the Mayo Clinic and Group Chair of the North Central Cancer Treatment Group recalls: "We realized we could not move forward and make further advances in cancer management without greater involvement in trials by both patients and physicians. As a result, eight cooperative groups united to lead the campaign for higher trial enrollment and formed the Coalition, the only national non-profit organization dedicated solely to this cause."
The work of the cooperative groups that conduct the majority of the nation's large-scale, rigorously monitored cancer clinical trials in academic settings and community oncology practices brought about many new practices during the second half of the 20th century that are today's standard of care. Among them are the breast-saving technique of lumpectomy and radiation therapy, that was proven as effective as radical mastectomy in the treatment of breast cancer; the development of new chemotherapy approaches resulting in a 44 percent decrease in the death rate from colon cancer; and a combination of chemotherapy and radiation that has proven to be the most effective treatment for advanced cervical cancer.
Increasing Understanding—Increasing Participation
Understanding attitudes toward cancer clinical trials is crucial to removing obstacles that hinder higher participation rates. Last year, the Coalition and its partners— the Cancer Leadership Council, the Cancer Research Foundation of America and the Oncology Nursing Society —commissioned the first Harris InteractiveSM survey of public attitudes toward cancer clinical trials. The study revealed that the public has a number of misconceptions about clinical trials. They include the fear of receiving a placebo, concern over being treated like a "guinea pig" and fear that insurance will not cover costs.
To overcome these hurdles, the Coalition developed a national awareness campaign that educates the public about the value of cancer clinical trials as a high-quality treatment option and their importance in the research process. The campaign is also designed to clarify misconceptions and encourage dialogue between patients and their physicians. At the same time, to assist doctors and healthcare professionals, the Coalition has released TrialCheckSM, a "real-time" search tool that queries and screens approximately 300 cooperative group clinical trials. TrialCheckSM enables physicians and their staff to identify quickly which trial(s) may be appropriate for a patient. The Coalition is also working with pharmaceutical and biotech companies to include federally approved industry trials.
Early next year, a specially tailored version of TrialCheckSM will be available to the 27 patient advocate organizations that are members of the Coalition. Collectively, these organizations represent thousands of patients and all major cancer types. With this service, participating patient advocate organizations will be able to help identify trials that may be appropriate and direct patients and their families to hospitals, cancer centers and community oncology practices where the trials are being conducted.
Partnering to Find a Cure
Breakthroughs in cancer treatment are achieved when government, physicians, researchers and drug developers work together. Considering the urgent need for a single forum for patients, patient advocacy organizations, government health agencies, the pharmaceutical industry and insurers, the Coalition and its partners, including the American Society of Clinical Oncology (ASCO), meet annually at the Summit on Cancer Clinical Trials to discuss their perspectives and concerns.
"Summit participants have called for a single, cross-sector definition of a high-quality clinical trial, and for improved interaction and collaboration among patients, physicians' groups and organizations coordinating clinical trials," says Carolyn Aldigé, president and founder of the Cancer Research Foundation of America, a Summit sponsor. "We have also set a national goal: to double adult participation in clinical trials, which is now between three and five percent of cancer patients."
Partnerships are also being formed to reverse the decline in numbers of physicians choosing careers in patient-based research. "To address this potentially severe problem," says Larry Norton, M.D., chief of solid tumor oncology at Memorial Sloan-Kettering Cancer Center and president of ASCO, "we have two very active programs supporting young investigators, the Young Investigator Awards and the Career Development Awards. These are funded by industry and several foundations, including the Don Shula Foundation and The Breast Cancer Research Foundation."
With the rise of the biotech industry, the current level of public funding of research, and higher research costs for drug development, a new synergy has been created among pharmaceutical, biotech and other cancer research organizations. Drug development is an extremely expensive process. Estimates stand at an average of $500 million for each new drug, and only one out of ten makes it through clinical trials. In recent years, major pharmaceutical companies have partnered with small genomic and biotech companies to facilitate development and lower costs.
New Advances in Cancer Treatment
Many of the drugs being developed today will be tailored to specific illnesses and targeted to more select populations. Researchers are not seeking the one elusive cure for all cancers, but the most successful mix of therapies, which might involve surgery, chemotherapy, radiation and alternative treatments, alone, or in combination. For example, clinical trials are now testing chemotherapy combinations of new and/or proven anti-cancer drugs, as well as chemotherapy in conjunction with targeted biological agents. Leading-edge radiation methods, some of which are available through clinical trials, target tumors for high-dose destruction and leave the normal surrounding tissue untouched.
In many cases, these treatments are yielding promising results with a variety of cancers, including brain, lung and prostate. "By combining more traditional therapies with others in developmental stages, we will slowly but surely make cancer a chronic, but manageable disease," says Norman Wolmark, M.D., chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP). "The emphasis will increasingly shift to prevention."
Continued research refines our understanding of cancer, which appears to result from abnormalities that may occur in hundreds of genes, proteins, cellular growth mechanisms and other substances that make cancer cells appear and grow unchecked. Once they learn the chemical signatures of tumors and comprehend how a healthy cell transforms into a particular type of cancer cell, and what it needs to grow and spread, scientists can try to block these chemical processes with agents that target tumors for elimination.
These biotherapies have the potential to stop, control or suppress the growth of cancer cells, prevent the spread of tumors and alter growth patterns that change healthy cells into cancerous ones. "In this way, we may be able to stop the growth and spread of cancer in a patient for long stretches of time. These types of agents also appear to synergize with radiation therapy and with proven chemotherapeutic agents, thereby improving the chances of eradicating the cancer," says John Mendelsohn, M.D., president of the University of Texas M.D. Anderson Cancer Center in Houston. These substances may also be capable of boosting the killing power of immune system cells, making cancer more recognizable so that the body's natural defenses fight the intruder, and increasing the body's ability to repair or replace healthy cells damaged by chemotherapy or radiation treatment.
Biotherapies appear in many forms, from pills to genetically altered viruses that allow therapeutic genes to hitch a ride into the body. The revolutionary aspect of these therapies is that they kill only the tumor cells and leave healthy ones untouched. Researchers are also looking at ways to use immunotherapy to strengthen the immune system, which can enable patients to receive larger doses of chemotherapy and radiation while reducing side effects.
If you are diagnosed with cancer and investigate the possibility of a clinical trial, you may find more extensive treatment options than you expected. They may include a vaccine, administered after diagnosis, that uses your immune system to fight the disease, or an anti-angio genesis agent that can "starve" a tumor by cutting off its blood supply, thus depriving it of the oxygen and nutrients it needs to grow. Perhaps you would be eligible for a trial testing one of the many combinations of specifically designed small molecules, proteins, stem cells or antibodies that work against cancer. Though not yet the standard of care, these are some of the revolutionary treatments that may be available through a clinical trial.
Call to Action
Thanks to scientific advances, the 1.2 million people in the U.S. who will be diagnosed with cancer this year should have more hope than fear. Nonetheless, the pace of research must be quickened in order to continue increasing survival rates. While cures for specific cancers might not be around the corner, we do know that many can become chronic, manageable diseases. "For some, that day is already here," says Ellen Stovall. "With increased participation in clinical trials, successful cancer management will become routine in the foreseeable future."
As a member of corporate America, you can play a role in helping make new cancer treatments available more rapidly to all cancer patients. Work with your insurance provider to offer coverage of clinical trials, and then reassure your employees that their healthcare costs will be covered. If you hold a management position in a corporation or large organization, work with the Coalition to educate your employees and customers about cancer clinical trials and help correct the misconceptions that were documented in the Harris survey.
You can also post information about cancer clinical trials on your Intranet or write an article for your in-house magazine. "The key to getting around barriers that surround words like experimental and investigational is education," says Carolyn Aldigé. "We simply cannot expect people to enroll in a clinical trial if they don't understand what they're being asked to do. Education from a variety of viewpoints and media, as well as through physicians, is critical to increasing enrollment in clinical trials."
According to the American Cancer Society, half of all men and one-third of all women in America will develop cancer in his or her lifetime. At this time, their five-year relative survival rate will be 60 percent. We all know people who have been diagnosed. We are all affected. If we work together to increase participation in clinical trials, we may all play a significant role in prolonging and improving the lives of cancer patients.
Visit the Coalition's Web site, www.cancertrialshelp.org/atwork for additional information on cancer clinical trials, the Harris InteractiveSM survey, updates about TrialCheckSM, and to obtain materials for posting on your company's Intranet or in-house magazines.
Coalition of National Cancer Cooperative Groups, Inc.
The mission of the Coalition of National Cancer Cooperative Groups, a non-profit, charitable organization formed in 1997, links the not-for-profit foundations of the major cooperative groups into one organization whose mission is to improve the survival and quality of life of cancer patients through increased participation in cancer clinical trials. Its programs address issues identified at the annual Summit Series on Cancer Clinical Trials, such as lack of public awareness, myths about cancer clinical trial participation, patient barriers to enrollment, regulatory requirements, clinical trial research funding and patient care costs.
The membership of the Coalition includes oncologists, cancer research specialists, patient advocacy organizations, cancer centers, academic medical centers and community hospitals and practices. To assist its members in serving the public, the Coalition provides education, training and ongoing professional support. Its goal is to double adult participation in cancer clinical trials by the year 2005, thus enabling new treatments to be available more quickly to all cancer patients.
For more information, contact the Coalition of National Cancer Cooperative Groups, 1818 Market Street, Suite 1100, Philadelphia, PA 19103.
Pharmacia Corporation
Today's clinical trials are tomorrow's standard of care, facilitated through strategic partnerships between industry, government and research institutions. Our collaborations with advocacy groups, including the Coalition of National Cancer Cooperative Groups, American Cancer Society and National Colorectal Cancer Research Alliance, help raise awareness of cancer clinical trials, minimize misconceptions and maximize enrollment, ultimately making a difference in treatment outcomes.
Each sector plays a role: Industry focuses on discovering and developing technology and cooperative groups study clinical strategies to meet medical needs. Government's role is more complex, as it funds research, mandates regulatory and reimbursement policies and runs many clinical trials. Regulators and lawmakers must understand these complex relationships in order to establish constructive policies.
Baby boomers' proactive health attitudes suggest that cancer prevention will be among their primary goals. We are redefining cancer research and leading efforts to test prevention therapies that will allow many to avoid the disease. Our researchers, along with the people at risk who are enrolling in clinical trials, will be pioneers in pushing cancer back before it starts.
In treatment, cancer will never be obliterated by a single miracle drug. The "magic cocktail" of the future will result from collaborative efforts combining current treatments with novel agents, known as molecular oncology drugs. Greater knowledge of molecular biology and genomics, and a paradigm shift regarding clinical trials will transform research into reality. We are committed to working with others to bring about changes in prevention and treatment that we already know are possible.
Aventis Pharmaceuticals
Our company is committed to playing a leadership role in oncology research and patient care. We believe that progress can be accomplished only through an integrated, broad-spectrum approach. Our unique, global research efforts include new cytotoxic drugs, biological agents, third-generation taxanes and immunotherapy strategies. The scientists and clinical investigators on our team focus on both treating the disease and improving supportive care. To this end, our R&D programs involve leading cancer experts, the National Cancer Institute (NCI), academic institutions, cooperative groups and biotech companies.
Having already developed one of the most widely prescribed chemotherapeutic agents, a taxane indicated for breast and lung cancers, our current research efforts emphasize the treatment of prostate, head/neck, gastric and ovarian cancers.
The future will bring a better understanding of drug resistance, genetic factors and biological markers that will advance targeted therapies designed for the treatment of specific cancers. For example, we have initiated clinical trials with more potent taxanes designed to overcome drug resistance and offer patients significant clinical benefits. In collaboration with the NCI, we are developing the first agent that specifically targets enzymes that control the abnormal growth cycle of cancer cells. We have also begun clinical trials with a vascular targeting agent that may shrink tumors by selectively cutting off their blood supply.
As we strive to change how cancer will be treated in the 21st century, we will provide physicians with new tools to treat cancer and give patients effective therapies as varied as the patients themselves.
Aventis Pharmaceuticals
Eli Lilly and Company
As patients and their families become more informed about cancer, they will undoubtedly take a greater role in choosing their cancer therapies, including those being evaluated within the context of a clinical trial. By communicating their needs and opinions more clearly and urgently to healthcare providers, patients may also succeed in convincing institutions to conduct more clinical trials. Increased trial enrollment will hasten drug development and bring innovative products to the marketplace more quickly.
Equally important are the physicians who dedicate themselves to research. The observations they make in clinical trials often serve as the basis for new directions in research. That is why we support public and private efforts to reverse the 15 year decline in the number of clinical investigators. Our support of the Clinical Investigator Award of the Damon Runyon Cancer Research Foundation provides the resources and training structure essential to bringing more physicians into the clinical research discipline.
Innovative work in molecular targeting, angiogenesis and the sequencing of the human genome are leading to development of drugs that attack cancer differently. Sequencing also helps to better define cancer in genetic terms at diagnosis. Ultimately, this work may transform cancer from an acute disease to a chronic condition.
Laboratory researchers, physician-scientists and patients all share a common passion, if not a responsibility, in managing cancer. Only by working together can we answer the tough clinical questions and leverage capabilities in getting drugs to the public as quickly as possible. Ultimately, this is an issue that affects the global community of cancer research.
Bristol-Myers Squibb Company
All the participants in cancer research share a mission to extend and enhance human life. Today, more than ever, people with cancer are living longer and healthier lives as a result of clinical research. Today, people living with cancer have hope for the future.
Lance Armstrong is a powerful illustration of that hope. In 1996, this promising 26-year-old competitive cyclist was diagnosed with advanced testicular cancer. His condition was serious, but not hopeless. Lance put himself under the care of a skilled medical team that had developed, through a series of clinical trials, a treatment that showed that chemotherapy was highly effective in treating testicular cancer. After surgery and a course of therapy, Lance was cancer-free.
That was five years ago. Now, Lance is the three-time winner of the Tour de France and an Olympic athlete. But without those groundbreaking clinical trials, Lance would not be alive today.
Following Lance's recovery, our company partnered with Lance and the Lance Armstrong Foundation to create the Cycle of Hope, a national cancer program designed to educate the public and to foster hope among patients and families fighting the disease.
Lance Armstrong gives hope to millions: hope that more research will result in more success; hope that cancer can be cured. I look forward to a future in which we and our children no longer live in fear of cancer, a future in which fear has been replaced by hope. Lance Armstrong gives hope to millions: hope that more research will result in more success; hope that cancer can be cured. I look forward to a future in which we and our children no longer live in fear of cancer, a future in which fear has been replaced by hope.
Ortho Biotech, A Johnson & Johnson Company
Clinical trials are the backbone of our worldwide research efforts. We are focused on discovering and developing innovative products to treat serious, life-threatening diseases like HIV and cancer, particularly those that current therapies do not treat adequately, such as pancreatic cancer and sarcoma. We are currently in late-stage clinical trials with a new cancer medication at sites around the world.
Our research companies are using the latest discoveries in biotechnology to streamline and enhance the discovery of new medicines. Through the use of advanced screening techniques, molecular modeling, computer-assisted drug discovery and other research technologies, our scientists are reducing the time it takes to discover and evaluate promising compounds by half—from three to four years to 18 months. The focus of these efforts is the development of new biologic and small molecule therapeutics, as well as maximizing the potential of existing products. In 2000, company researchers brought 20 new chemical entities into early development, and we expect that number to grow significantly in 2001.
This research, conducted in partnership with others, is helping us to develop better medicines that are convenient and cost-effective for healthcare professionals and patients. We are proud to work with some of the world's leading academic and research institutions and emerging biotechnology companies. Together, we are committed to identifying promising new therapies, evaluating their effectiveness and safety via clinical trials, and providing them to patients who need them, as quickly as possible.
For more information about how you can help the Coalition of National Cancer Cooperative Groups increase participation in cancer clinical trials, contact Nancy Powell Connelly, Director of Communication, at nconnelly@cancertrialshelp.org
| Coalition of National Cancer Cooperative Groups |
Benefactors |
| Aventis Pharmaceuticals | Eli Lilly and Company |
| Bristol-Myers Squibb Co. | Pharmacia Corporation |
| Patrons |
| Ortho Biotech Products, L.P. |
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| Contributors |
| Genentech, Inc. | W.E.B. Foundation | |
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Cooperative Group Members
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American College of Surgeons Oncology Group (ACOSOG)
Samuel A. Wells, Jr., M.D., Chair
Cancer and Leukemia Group B (CALGB)
Richard L. Schilsky, M.D., Chair
Eastern Cooperative Oncology Group (ECOG)
Robert L. Comis, M.D., Chair
Gynecologic Oncology Group (GOG)
Robert C. Park, M.D., Chair
North Central Cancer Treatment Group (NCCTG)
Michael J. O'Connell, M.D., Chair
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Norman Wolmark, M.D., Chair
Pediatric Oncology Group (POG)
Sharon B. Murphy, M.D., Chair Emeritus
Radiation Therapy Oncology Group (RTOG)
Walter J. Curran, M.D., Chair
Radiation Therapy Oncology Group (RTOG)
Walter J. Curran, M.D., Chair
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Resource Directory
Cancer Clinical Trials Hotline
Provided by Aventis Pharmaceuticals 1-800-RxTrial
Cancer Survival Toolbox®(www.cansearch.org/programs/toolbox.htm)
Supported by Genentech® 1-877-TOOLS-4-U (1-877-866-5748)
Clinical Trials Resource Center (www.nccra.org),
Corporation, Pfizer, and the National Colorectal Cancer Research Alliance 1-877-724-4100
Cycle of Hope (www.cycleofhope.org),
Supported by Bristol-Myers Squibb Company 1-800-717-HOPE
National awareness campaign directed by The Colaizzi Group, on behalf of the Coalition of National Cancer Cooperative Groups, Inc. (dianec@colaizzigroup.com)
For reprints, send an email to fortunereprints@cancertrialshelp.org.
Production Credits
Produced by Diane Gingold and Associates (info@dga1.com)
Designed by MGT Design, Inc.
Edited by Barbara Gingold and Sigrid MacRae
Cover Photography by Bruce Fleming. Interior Photography by Steven E. Purcell and Peter Vidor
Robert L. Comis, M.D. photograph by Robert Coldwell Commercial Photography
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