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Strike the 'guinea pig' notion; strict criteria ensure that patient, clinical trial are an ideal match
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Strike the 'guinea pig' notion; strict criteria ensure that patient, clinical trial are an ideal match

Clinical trials 101

Every drug that comes to market has a stringent series of clinical trials behind it. And Quality Clinical Research Inc. of Omaha is among the players.

In the past decade, “we’ve helped secure FDA approval for 45 or more drugs,” said QCR vice president Seneca Harrison. Among them: Celebrex (an anti-inflammatory drug) and Viagra (for treatment of erectile dysfunction).

“When you participate in a QCR trial, you’re a patient under the care and guidance of an expertly trained medical staff,” said Harrison. “You’re not a guinea pig, which sometimes is the misconception.”

Some health care professionals running clinical trials for QCR work out of QCR’s Regency offices, while others are affiliated with a major health system or other metro satellite location with specialized doctors, labs or testing equipment, according to Harrison.

How QCR lands trials

“Pharmaceutical companies approach us to see if we can handle a particular study,” said Harrison, who launched QCR in 2003 with wife, Tricia, as CEO and clinic coordinator. The answer depends on the criteria for the study and the number of qualifying candidates in the clinic’s database.

“We have very stringent criteria for studies,” Harrison said. "We follow a clinical trial’s criteria to the letter. It’s safe.”

Quality Clinical Research currently is conducting trials for 33 pharmaceutical and health care companies. Allergan, Novartis and Pfizer are among the more widely known. Study participants might range from a newborn who can’t drink breast milk to a teen athlete who suffers from exercise-induced asthma to an 85-year-old at high risk for influenza. “Pretty much any walk of life.”

The value of clinical studies became personal for Harrison and his family in 2008. His sister died that year from sickle cell anemia, an inherited blood disease traced to abnormal hemoglobin. She was 28 and left behind three children — 6-month-old twins and a 3-year-old.

“My mother has full-blown sickle cell anemia traits,” Harrison offered. “And I carry the trait.” Since 2004, much has been discovered about the disease through clinical studies.

Who can participate

Participation in a clinical trial is not a given for everyone who applies. Candidates register online and are screened through an inclusion/exclusion assessment that’s usually done by phone.

Those who meet the baseline criteria are scheduled for lab work and may be asked to keep a seven-day health diary that may knock them out of a particular study.

“Some studies may need patients with an overactive bladder, chronic back pain, etc. Our screening process confirms that you suffer from the condition specific to the trial,” Harrison explained.

QCR hosts Phase I through IV studies. Typically 20 to 25 different trials might be in progress at any given time, and each study is facilitated by a physician who acts as principal investigator and a nurse coordinator.

Pharmaceutical companies set forth the criteria, train the principal investigator and coordinator of the study, verify the eligibility of each participant, and monitor results for the duration of the trial.

“We stay in close contact with the patient’s doctor, forwarding lab, EKG and other test results as we go,” Harrison said. “We don’t treat patients outside the protocols of a study, and once the trial is complete, the patient is returned to their primary physician.”

The four trial phases

Phase I trials are the first trials to involve people and are small, usually involving 15 to 50 participants. Phase II trials look at the effectiveness of a new treatment in 25 to 100 people.

Phase III trials are large (some involve tens of thousands of participants) and compare the safety and effectiveness of a new treatment to the current standard.

Phase IV trials usually look at whether a treatment offers benefits or produces long-term side effects that weren’t studied or seen in Phase II or Phase III trials and may involve hundreds of thousands of people.

How to see if you're a good fit

A clinical trial might be for you if …

  • You enjoy the idea of helping others while helping yourself. “You want to do it for the greater good.”
  • You’re healthy, or you have a chronic ailment or condition and a resolve to feel better.
  • You’re a minority. “Some blood pressure studies, for example, are only for the African-American population,” Harrison said.
  • You’ve lost your medical coverage and suddenly need a bridge. Medications, lab work, tests (including annual wellness checks), equipment and condition management are free for the duration of a study related to your condition.
  • Your schedule can accommodate weekend, evening or early-morning appointments.
  • You could use the income — although Harrison cautions that a clinical trial is not a quick cash grab. Compensation depends on the phase of the trial, the area of medicine or how much a medicine or treatment has already been tested. Risk also comes into play.

“Each study is different,” Harrison said. “Some diabetes and cholesterol studies can take place over an eight-year period. But more typically, a trial will run 18 months.”

To ballpark the compensation: A trial might pay $50 to $100 for a one-time clinic visit, $500 to $1,000 for overnight testing or $1,000 to $1,500 for 15 to 20 visits.

Another value: You can see your primary care physician and request that medical reports be sent to your doctor during the trial period.

Sometimes during the screening process, participants learn of a disease or condition they didn’t know they had, Harrison said. “Lupus. Cancer. We have discovered those conditions.”

QCR patients have an 85 to 90 percent completion rate, according to Harrison. “Our dropout rate is low and our completion rate is high.”

Safe clinical trials are critical to discovering new treatments for cancer and other diseases as well as new ways to detect, diagnose and reduce the risk of disease, Harrison observed. “It’s a forever industry.”

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