O'Neal Comprehensive Cancer Center Magazine | Page 47

CLINICAL TRIALS 101
A clinical trial is a specific type of medical research in which humans are studied to see how they respond to promising new treatments , including drugs , therapies , devices and procedures . Clinical trials often lead to treatments or even cures that are safer , more effective and have fewer side effects . The clinical trial process is regulated by the U . S . Food and Drug Administration ( FDA ), which is responsible for authorizing new treatments to enter the health care market .
FINDING BETTER WAYS Health researchers are always looking for better ways to identify , diagnose , treat , manage and prevent medical conditions . Whether publicly or privately funded , research often begins with pre-clinical testing , meaning tests done in a laboratory without human participants .
When researchers find a possible treatment , they first test it in computer models , bacterial cultures and / or on isolated human cells . If the treatment seems to work , the testing usually advances to animals , to learn how it affects them and how it might affect humans . Preclinical testing may span months or years .
The treatments that make it to clinical trials already have shown promise and a reasonable risk-to-benefit ratio . The standards for entering a clinical trial are so strict that only about five in 5,000 new treatments that begin the road toward clinical trials are approved by the FDA for human testing .
Once a treatment is optimized in the laboratory , a public or private entity ( called a sponsor ) may apply for an Investigational New Drug ( IND ) application with the FDA . The FDA decides whether it is reasonably safe for the sponsor to move forward with testing the treatment in humans . The clinical trial process usually takes several more years .
By the time a clinical trial is offered as a beneficial treatment option to patients , its potential is clear , and it has been determined to be relatively safe . The plan for a clinical trial must gain approval from the FDA and be overseen by an institutional review board ( IRB ), a panel of scientists and non-scientists at research institutions such as UAB Medicine .
THE CLINICAL TRIALS OFFICE AT THE O ’ NEAL COMPREHENSIVE CANCER CENTER
The fight against cancer is a team effort . And as with most teams , some members are more prominent than others . Still , all team members make important contributions , whether they work directly with patients or in administrative roles .
At the O ’ Neal Comprehensive Cancer Center , the dedicated professionals known as clinical research coordinators play an important role in the clinical trial process .
“ We ’ re kind of liaisons between the patient , the research investigator and the clinical team ,” said Vicky Poss , who has worked at UAB Medicine since 1992 . “ We give all of them information , because we ’ re the ones who know the protocols . We ’ re that resource for people to ask questions about the trial .”
As deputy director of the O ’ Neal Comprehensive Cancer Center , Bassel El-Rayes , M . D ., regularly witnesses the vital contribution that administrative coordinators make to the clinical trial process .
“ Everybody knows about the physician , the nurse and the pharmacist , but also important are the people who work in the Clinical Trials Office ,” Dr . El-Rayes said . “ They help physicians administer these trials , they collect and report the information that results from the trial and they work with the patients to ensure their safety . They keep the trial moving along .”
Such work is important , Dr . El-Rayes said , because conducting clinical trials is a requirement for the O ’ Neal Comprehensive Cancer Center to maintain its designation from the National Cancer Institute ( NCI ) as a Comprehensive Cancer Center .
“ One of the expectations from the NCI is that we develop and participate in clinical trials to test the new treatments that improve cancer outcomes across the country ,” Dr . El-Rayes said . “ We are always looking for new treatments that are more effective than the treatments we have now or that are safer with fewer side effects .
“ Unless we test in a systematic way through clinical trials , it would be hard to move the field forward and have reliable data about new treatments ,” Dr . El-Rayes continued . “ The impact of the clinical trials that have been done here has resulted in a huge change in the way we treat cancer and a significant improvement in the outcomes for patients with cancer .” — CARY ESTES
THE FOUR PHASES
Clinical trials advance through three phases to test a treatment , find the appropriate dosage , and look for side effects . After the first three phases , if researchers find a treatment to be safe and effective , the FDA approves it for patient use and continues to monitor its effects in a fourth phase .
A PHASE I TRIAL tests an experimental treatment on a small group of people ( usually numbering 20-80 ) to judge its safety and side effects and determine the correct dosage .
A PHASE II TRIAL involves more people ( 100-300 ). While the emphasis in phase 1 is on safety , the emphasis in phase 2 is on effectiveness . This phase seeks to obtain data on whether the treatment works in people who have a certain disease or condition . These trials also continue to study safety , including short-term side effects .
A PHASE III TRIAL gathers more information about safety and effectiveness , studying different populations and different dosages and combining the treatment with other drugs . The number of participants usually ranges from several hundred to about 3,000 . If the FDA agrees that the trial results are positive , it will approve the experimental drug or device .
A PHASE IV TRIAL takes place after the FDA approves the treatment or device and is done to monitor for longer-term effects .
— DON MILAZZO & GREG ROBINSON
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