Frequently Asked Questions

Choosing whether or not participating in a clinical trial is an important personal decision, and we understand that you want all of the information

Am I a volunteering to be a "human guinea pig?"

North Star Medical Research conducts clinical trials only with investigational agents that have already been extensively tested in animals (the "pre-clinical" phase), and in healthy volunteers to establish dose ranges and assess side effects ("Phase I"). Our trials build on this foundation to further establish safety and efficacy. All NSMR study participants are treated ethically and respectfully.

Why are clinical trials performed?

Clinical trials are performed to bring tomorrow's treatments to patients in need. No new treatments get approved for use by the Food and Drug Administration (FDA) without the millions of volunteers who dedicate themselves to the clinical research demanded by the FDA - research to bring more effective and better-tolerated treatments to doctors and their patients.

What risks will I be exposed to?

All medications carry risks and benefits. Potential NSMR participants undergo a thorough "informed consent" process to insure that risks, so far as they are known or foreseeable, are fully disclosed. However, as not all risks can be anticipated, participants in NSMR clinical trials are carefully monitored throughout.

What is a placebo?

A placebo is an inactive substance that takes the place of the drug under study in a clinical trial. In clinical trials, safety and efficacy are determined for the study drug against the inactive substance to bring the most objectivity possible to the process.

If a study drug is FDA approved, why is it "investigational medication"?

Any substance under study for a given diagnosis is called "investigational" by the FDA, even if its safety and efficacy have been thoroughly established by long clinical use for other diagnoses. North Star Medical Research studies only treatments that have been approved by the FDA for investigational purposes.

What will be expected of me as a volunteer?

Study volunteers are expected to prioritize their involvement in research by complying with the specific instructions given throughout the trial, as well as cooperating with study staff and physicians.

How is my personal health information protected?

The ethical and legal codes that govern a modern medical practice also apply to clinical trials. Most clinical research is federally regulated, with built-in safeguards to protect your privacy. The informed consent process addresses this issue specifically for each study.

Do I need insurance? Will my insurance be billed?

No insurance is required to participate in a clinical trial; participant health insurance information is not routinely collected, nor is insurance billed for research procedures.

How much will I be compensated?

In recognition of the dedication that clinical trial participants bring to research, compensation is offered for time and travel. Actual levels of compensation differ from trial to trial, and will be discussed in detail during the informed consent process.



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