Research in Your Backyard Developing Cures, Creating Jobs PHARMACEUTICAL Dots show locations of clinical trials in the state. CLINICAL TRIALS IN COLORADO Executive Summary This report shows that biopharmaceutical research com- all over the state, including Boulder, Colorado Springs, panies continue to be vitally important to the economy Denver, Grand Junction and Lakewood. and patient health in Colorado, despite the recession. At a time when the state still faces significant economic “The University of Colorado (CU) plays a major challenges, biopharmaceutical research companies are role in clinical research. CU is one of a handful conducting or have conducted more than 3,000 clinical of universities that has created four different trials of new medicines in collaboration with the state’s drugs that have been approved for marketing. clinical research centers, university medical schools and CU also has created 18 different drugs currently hospitals. Of the more than 3,000 clinical trials, 1,427 undergoing clinical trials. Additionally, six CU target or have targeted the nation’s six most debilitating created drugs have been approved for clinical chronic diseases—asthma, cancer, diabetes, heart disease, trials, and 44 drugs are in various stages of mental illnesses and stroke. pre-clinical trials. CU clinicians are also active in conducting clinical trials. For example, for What are Clinical Trials? the 2 month period between January 5, 2012 and In the development of new medicines, clinical trials are March 5, 2012, CU was seeking volunteers for conducted to prove therapeutic safety and effectiveness 50 different and newly initiated clinical trials. and compile the evidence needed for the Food and Drug These clinical related activities address a wide Administration to approve treatments. Clinical tests of array of human maladies and provide significant new drugs are conducted in three phases and account for economic activity for the State of Colorado.” seven of the 10 to 15 years required for drug development — David N. Allen, Ph.D. and approval. University of Colorado Associate Vice President for Technology Transfer Clinical trials involve thousands of volunteer patient participants, the generation of tens of thousands of pages of technical and scientific data and are responsible for 45 to 75 percent of the $1.2 billion average cost of developing one new cutting-edge For patients, the trials offer another potential therapeutic biotechnology medicine. option. Clinical tests may provide a new avenue of care for some chronic disease sufferers who are still searching Quite often, biopharmaceutical companies hire local research institutions to conduct the tests and in Colorado, for the medicines that are best for them. More than 280 of they help to bolster local economies in communities the trials underway in Colorado are still recruiting patients. 2 PhRMA • PHARMACEUTICAL CLINICAL TRIALS IN COLORADO Participants in clinical trials can: Local Involvement • Play an active role in their health care. Colorado institutions involved in clinical tests of treat- • Gain access to new research treatments before they ments include medical schools, research centers and are widely available. hospitals, such as: • Obtain expert medical care at leading health care • Catholic Health Initiatives, Colorado Springs facilities during the trial. • National Jewish Health, Denver • Help others by contributing to medical research. • Storms Clinical Research Institute, Colorado Springs Patient Safety in Clinical Trials • Children’s Hospital, Aurora • All tests must be reviewed and approved by an Institutional Review Board (IRB), an independent • Denver Health Medical Center, Denver committee of physicians, statisticians, local • University of Colorado-Denver School of community advocates and others to ensure a trial is Medicine, Aurora ethically conducted and patient rights are protected. • Memorial Hospital, Colorado Springs • Clinical trial progress reports must be submitted at least annually to the Food and Drug Administration • St. Mary’s Regional Cancer Center, Grand and the IRB. Junction • All facilities that conduct or support biomedical • Medical Center of the Rockies, Fort Collins research involving patients must comply with federal regulations and have an IRB. The biopharmaceutical research companies working with these institutions have targeted disease wisely— Many different entities and individuals contribute to the about half of Colorado’s new medicine clinical trials safe and appropriate conduct of clinical research, includ- are aimed at chronic conditions that plague patients all ing not only sponsoring companies but also regulatory over the state, including cancer, diabetes, heart disease agencies; investigative site staff and medical professionals and stroke. who serve as clinical investigators; hospitals and other institutions where research is conducted; and institutional There are 281 clinical trials recruiting patients all over review boards and ethics committees. the state. These trials target the top six chronic diseases —asthma, cancer, diabetes, heart disease, mental illness and stroke. Clinical Trials in Colorado since 1999— Completed and Active Equally as important is the fact that many of the medi- cines being clinically tested here are new-generation All Clinical Trials Six Major Chronic Diseases biotechnology treatments. With biotechnology, we have 3,044 1,427 the potential to develop safer and more effective thera- pies and we can improve our ability to predict, preempt Source: www.clinicaltrials.gov or even prevent disease. Note: Search criteria = Colorado, Phase I, II, III; industry only. Search performed 3/4/2012. DEVELOPING CURES, CREATING JOBS • A PARTNERSHIP BETWEEN BIOPHARMACEUTICAL COMPANIES AND STATE RESEARCH INSTITUTIONS 3 Economic Impact of Earlier reports show biopharmaceutical research Biopharmaceutical Companies companies have been an important source of research spending: “The Biopharmaceutical industry in Colorado • A study by Archstone Consulting found that is a vital part of Colorado’s economy. This in 2008 biopharmaceutical research firms that sector includes approximately 300 companies year also invested $379.9 million in research employing over 5, 410 with average salaries and development and provided $10.8 billion in products and services. of $93,000. Not only are these high paying high tech jobs but each are working on the innovative life saving medicines of the future.“ — Holli Riebel President and CEO, Colorado BioScience Association Clinical Trials in Colorado Communities Location Asthma Cancer Diabetes Heart Disease Mental Illness Stroke Arvada 0 0 2 1 0 1 Aurora 0 97 14 5 7 1 Centennial 4 1 0 0 0 0 Colorado Springs 10 13 11 11 4 2 Denver 10 97 20 11 27 3 Englewood 1 6 0 1 1 1 Fort Collins 0 4 1 4 0 0 Grand Junction 0 10 0 0 0 0 Highlands Ranch 0 0 0 0 3 0 Lone Tree 0 8 0 1 0 1 Loveland 0 1 0 1 0 0 Wheat Ridge 5 0 1 3 0 1 Source: www.clinicaltrials.gov Note: Search criteria = Colorado, Phase I, II, II; industry only. Search performed 3/4/2012. See Appendix for detailed information about these clinical trials. Disease columns will not add to totals in Appendix because some clinical trials are recruiting in more than one city. 4 PhRMA • PHARMACEUTICAL CLINICAL TRIALS IN COLORADO The Need for New Chronic treat those conditions that are taking an unprecedented Disease Medicines toll on American lives. Many of these medicines are being tested today in clinical “Compared to life a few decades ago, people with trials throughout Colorado. asthma today have a far better quality of life and greatly reduced risk of morbidity. This is primarily At a time when tens of thousands of state residents are due to research which has already produced suffering from one or more chronic diseases, America’s a wide array of medicines that help patients biopharmaceutical research companies are sponsoring control their asthma. Given these improvements, or have sponsored 1,427 clinical trials of potential new much of the general public may view asthma as medicines in the Centennial State alone for asthma, an inconvenience, and certainly not as a life- cancer, heart disease, stroke, diabetes and mental threatening condition. Many would be surprised to illnesses. Of the 1,427 trials, 281 are either not yet re- hear that asthma still causes over 3400 deaths per cruiting or are just now seeking Colorado patients, giving year in the U.S., and is a leading cause of absence those still searching for effective treatments potential new from school and work. Going forward, it is vitally options and new hope. important that research continue on asthma medications, both to increase their efficacy and Many of the state’s clinical tests involve collaborations to minimize side effects. Colorado is fortunate to with such respected local institutions as the University have outstanding research institutions that are of Colorado-Denver School of Medicine, the Chil- uniquely poised to continue this important work.” dren’s Hospital Colorado in Aurora, the Denver Health — Curt Huber Medical Center in Denver, the Medical Center of the Executive Director, American Lung Association in Colorado Rockies in Fort Collins and St. Mary’s Regional Cancer Center in Grand Junction. Chronic diseases pose the greatest threats to our nation’s Clinical Trials for Top Chronic Diseases health and our ability to treat and prevent medical condi- tions. According to the Centers for Disease Control and Clinical Trials Chronic Disease All Clinical Trials Prevention, today, in the United States: Still Recruiting Asthma 108 17 • Patients with chronic diseases account for 75 cents of every dollar spent on health care. Cancer 763 173 Diabetes 207 38 • Chronic diseases are the leading cause of death and disability. Heart Disease 103 18 Mental Illness 229 30 • Chronic diseases are a leading driver of rising health care costs with expenses totaling billions of Stroke 17 5 dollars every year. Total 1,427 281 With the stakes so high, America’s biopharmaceutical Source: www.clinicaltrials.gov Note: Search criteria = Colorado, Phase I, II, III; industry only. research companies are developing new medicines to help Search performed 3/4/2012.