About Clinical Trials
Medical innovations and new, effective treatments have the power to change lives, but these breakthroughs don’t happen on their own. The research that goes into each new way to treat an illness or condition is comprehensive and involves various steps to ensure treatments truly work.
What to
Expect
Since clinical trials are often conducted in a doctor’s office, patients may need to devote more time to physician visits and physical examinations. They may also have additional responsibilities, like keeping a daily log of their health. All prospective participants must sign an informed consent document saying they understand that the clinical trial is research, and that they can leave the trial at any time. After consulting with their health care providers, patients can volunteer to participate, leading to a prescreening interview. If they fit the criteria and requirements of the trial, they can be enrolled.
Patient
Expenses
Patients should ask during pre-screening interviews what it will cost them to participate in a clinical trial. Clinical trial sponsors usually pay for all research-related expenses and additional testing or physician visits required by the trial. Patients or their insurance companies may be asked to pay for any routine treatments of their disease. And it’s important to know some health plans do not pay for clinical trials. Patients should make it a point to learn if they or their insurance company will be assessed any fees and should determine if their insurance company will cover the expense of routine examinations. Patients who live a distance from the trial site should learn the clinic’s policy for covering travel costs and living expenses. The National Cancer Institute, for example, makes patients responsible for their own travel costs for the initial screening visits. Once a patient is enrolled, the Institute will pay for transportation costs for all subsequent trial-related visits. These patients will receive a small per diem for food and lodging.
Expanded
Access
For patients with a serious or life-threatening disease who are ineligible or unable to participate in a clinical trial, use of an unapproved investigational medicine through an expanded access program may be an option. Expanded access is the use of an unapproved investigational medicine outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition, when there are no other comparable or satisfactory alternative treatment options. Expanded access programs are part of many biopharmaceutical companies’ commitment to patients.
Clinical Trial Phases
Developing innovative new medicines is a complex process taking an average 10-15 years. Less than 12 percent of candidate medicines that make it into clinical trials will be approved by the U.S. Food and Drug Administration. The process occurs in several phases:
Phase I
Researchers test the medicine in a small group of people, usually between 20 and 100 healthy adult volunteers, to evaluate its initial safety and tolerability profile, determine a safe dosage range and identify potential side effects.
Phase II
The medicine is given to volunteer patients, usually between 100 and 500 people, to study its efficacy, identify an optimal dose and to further evaluate its short-term safety.
Phase III
The medicine is provided to a larger, more diverse patient population, often involving between 1,000 and 5,000 patients (but sometimes many more thousands), to generate statistically significant evidence to confirm its safety and effectiveness. They are the longest studies and usually take place in multiple sites around the world.
Economic Impact
By providing millions of patients with new treatments and cures for society’s most devastating and costly diseases and conditions, the biopharmaceutical industry has a profound impact on peoples' lives. In addition, the industry also has a profound economic impact on Minnesota's economy.
The Impact of Clinical Trials in Minnesota
A TEConomy Partners study found that in 2017 alone, there were 653 active industry-sponsored clinical trials in Minnesota, with an estimated enrollment of 13,942 Minnesota residents. The investment at clinical trial sites was more than $218 million and the estimated total economic impact was nearly $630 million.
Beyond Minnesota, PhRMA member companies have invested over $800 billion in the research and development of new treatments and cures since 2000, including an estimated $71.4 billion in 2017 alone.
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Source: TEConomy Partners, Biopharmaceutical Industry-Sponsored Clinical Trials: Growing State Economies, April 2019
The Impact of the Biopharmaceutical Sector in Minnesota
Biopharmaceutical research companies have been and continue to be a good source of jobs, tax revenue and research spending in Minnesota. A study by TEConomy Partners found that in 2020, the industry supported more than 61,769 jobs throughout Minnesota. Wages and benefits for employees whose jobs were supported by the biopharmaceutical sector resulted in more than $1.1 billion in state and federal taxes paid.
Biopharmaceutical research companies supported the generation of $16.9 billion in economic activity in the state, including the direct economic output of the sector itself, the output of the sector’s vendors and suppliers and the output generated by the buying power of its workforce.
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Total value of goods and services supported by the biopharmaceutical sectorSource: TEConomy Partners, LLC. The Economic Impact of the U.S. Biopharmaceutical Industry: 2020 National and State Estimates. February 2022.