Research in Your Backyard Developing Cures, Creating Jobs PHARMACEUTICAL CLINICAL TRIALS IN MINNESOTA Dots show locations of clinical trials in the state. An Overview Clinical Trials in Minnesota St. Louis Park, Mercy Hospital in Coon Rapids, St. Mary’s Duluth Clinic in Duluth, St. Cloud • Biopharmaceutical research companies have Hospital in St. Cloud, St. Paul’s Heart Clinic conducted more than 2,400 clinical trials of new in St. Paul, University of Minnesota School of medicines since 1999 in collaboration with the Medicine in Minneapolis and the Mayo Clinic in state’s local research institutions, including the Rochester. Clinical Research Institute in Minneapolis and Plymouth, Twin Cities Clinical Research/Prism • The trials have been aimed at a wide array of Clinical Research in Brooklyn Center, Ridgeview diseases and medical conditions, ranging from Research in Chaska, Prism Clinical Research in the most debilitating chronic diseases, including St. Paul, MAPS Applied Research Center in Edina, cancer, pain, heart disease, obesity and diabetes, to Minnesotta Diet Research Center/Frestedt Inc. in bothersome allergies, sinusitis, chronic obstructive pulmonary disease (COPD), migraine headaches, pneumonia and rare diseases affecting small patient populations. “Clinical trials are required to get new medicines to the patients who need them. This is a • With so much clinical trial activity in the state, complicated business since completing a clinical widespread public awareness of trials is a challenge trial typically requires 6-7 years of effort. We must which led to the formation of a unique coalition— ensure the safety of each clinical trial participant the Minnesota Clinical Research Alliance to the extent possible while clearly measuring the (MCRA). effects of the new product. Enormous amounts of • MCRA provides important clinical research data are often collected and reviewed to evaluate education at a time when it is a challenge for the safety and efficacy of the product. Once biopharmaceutical companies and local research approved for the market, medicines continue to be collaborators to recruit volunteers and patients monitored by the companies that manufacture the often don’t know about trials of new drugs. products and the FDA to ensure their continued • Clinical trials in Minnesota have not only been safety and efficacy.” good for patients, but also the state’s economy and — Joy Frestedt, PhD, RAC, CCTI the advancement of science and overall patient President and CEO, Frestedt Incorporated health care. 2 PhRMA • PHARMACEUTICAL CLINICAL TRIALS IN MINNESOTA • In the words of Dr. Gary Berman of the Clinical Research Institute, an Alliance partner, the MCRA “Clinical research provides options for my has chosen “to put collaboration above competition patients who have conditions with very limited in the best interests of patients. We can all options. Not only do they have access to accomplish more by working together to promote compounds which are otherwise unavailable, the strength of research in Minnesota.” they also receive closer surveillance and • Many of the partners in the MCRA are heavily disease monitoring than they otherwise involved in the clinical testing of new medicines in would. Our clinical research program allows the state for a range of diseases, including infectious Kidney Specialists of Minnesota to provide our and respiratory conditions, cancer, asthma, migraine patients with treatments which far surpass the headaches, allergies and others. community standard of care.” • Some of the partners provide clinical research — Dr. Daniel Ries Co-Medical Director, Twin Cities Clinical Research expertise and sophisticated equipment that enable biopharmaceutical companies and their local collaborators to conduct trials of new medicines. • To learn about the companies that make up the Alliance, visit the website www.mnclinicalresearch.org. MCRA—Making Patients Aware of Clinical Trials and Their Importance • The website address of each partner is provided and at each site, explanations in easy-to-read • The MCRA was launched a year ago to educate language are provided about the important work the public, elected officials and the media about the of each organization. On some sites, information importance of clinical research to patients and the is provided on trials of new medicines that are still health care system and the state’s economy. recruiting patients, making them potentially very important to some disease sufferers and their health • A collaborative effort of key elements of the care providers. Minnesota medical research community, MCRA is dedicated to explaining research all over the state • MCRA partners include Agility Research, “in understandable terms.” Courante Oncology, the Clinical Research Institute, Frestedt Inc., MAPS Applied Research Center • Alliance presentations, media meetings, opinion (MARC), MEDTOX Laboratories, the Minnesota pieces and materials stress the patient safety Center for Obesity, Metabolism & Endocrinology protections built into the clinical trial system and (MNCOME), Minnesota Diet Research Center how trials of new drugs and medical devices are (MDRC), Minnesota Gastroenterology, Prism helping to advance science and, ultimately, overall Clinical Research, The Greenlight Group, LLC, patient health care. Ridgeview Research and Twin Cities Clinical • MCRA also stresses the economic impact of clinical Research/Prism Clinical Research. research on a state that, in 2010, had 11 percent of • The BioBusiness Alliance of Minnesota and all of the clinical trials conducted in the United LifeScience Alley, another bioscience support States. Minnesota also boasts the second highest organization, collaborate with the Alliance as number of medical technology jobs in the nation. affiliates. DEVELOPING CURES, CREATING JOBS • A PARTNERSHIP BETWEEN BIOPHARMACEUTICAL COMPANIES AND STATE RESEARCH INSTITUTIONS 3 About Clinical Trials and Why the • Clinical trials account for 45 to 75 percent of the MCRA Mission is Important average $1.2 billion cost of developing one new biotechnology medicine and that’s an important • According to a 2007 survey by CenterWatch, a statistic considering that biopharmaceutical company that publishes information on clinical companies frequently hire local research trials, patient enrollment problems delay more than institutions, such as members of the MCRA and 70 percent of the tests of new medicines from one the University of Minnesota School of Medicine, to six months. Fewer than five percent of cancer to conduct the tests. patients participate in clinical trials. The educational • For some patients who are still seeking treatments efforts of the MCRA help to create more that are best for them, clinical trials can be a awareness and understanding of trials of new drugs potential therapeutic option to discuss with health and that gives Minnesota patients the opportunity care providers. to discuss becoming trial volunteers with their doctors. • Many medicines clinically tested in Minnesota and other states are cutting-edge biotechnology • Delays in clinical trials mean drug development drugs that have the strong potential to advance takes longer, costs more and patients have to wait science and patient health care. Biotech medicines for treatments they may desperately need. are derived from novel biological processes that • Clinical trials are conducted to help evaluate feature cells, genes and other living organisms. With the safety and effectiveness of new medicines biotechnology, we have the strong potential to and generate the data the Food and Drug develop safer and more effective treatments and we Administration needs to approve new treatments. A are improving our ability to predict, preempt and drug cannot be approved without adequate clinical prevent diseases. testing. • From the standpoint of patient safety in clinical • Clinical tests of new drugs are conducted in three trials, all tests of new medicines must be reviewed pre-approval phases and account for an average and approved by an Institutional Review Board of seven of the 10 to 15 years required today to (IRB)—an independent committee of health care research and develop a new treatment. Trials involve providers, social workers, statisticians, local patient thousands of volunteer patients and the generation advocates and others—to ensure trials are ethically of large volumes—sometimes tens of thousands of conducted and patient rights protected. Many IRBs pages—of technical and scientific data. exist right here in the state of Minnesota. 4 PhRMA • PHARMACEUTICAL CLINICAL TRIALS IN MINNESOTA The Importance of Clinical Trials Since 1999, more than 2,400 clinical trials have been • Minnesota clinical research has been aimed at conducted or are being conducted in Minnesota. The cancer, diabetes, cardiovascular disease, HIV clinical trials have addressed many of the leading causes infection, mental and behavioral disorders, rare of death in the United States and in Minnesota, such as diseases and respiratory diseases. cancer, heart disease and diabetes. And they’ve targeted • Minnesota, in 2010, had the highest number of debilitating diseases that cause severe pain, such as psoria- investigational medical device and FDA pre-market sis, rheumatoid arthritis, and epilepsy. All of these condi- approvals of medical devices per capita. tions contribute to health care spending in Minnesota. • In 2008, health care spending in Minnesota was $35.1 billion—for hospital care, physician services, Clinical Trials