New trends are emerging to help physicians who traditionally have faced several challenges when conducting clinical trials.
These trends can help researchers avoid bias and obtain more accurate results in clinical trials, according to Valerie Arnold, MD, a psychiatrist and principal investigator for CNS Healthcare, a clinical trials center that explores treatment and medication options.
Being consistent and maintaining neutrality in a controlled environment is highly important when conducting a successful clinical trial. Patients must be chosen who fit specific criteria for each trial and maintain a neutral environment to avoid bias.
The use of technology, improved processes and advancements in genomics are improving the quality of studies, according to several Mid-South experts.
One of the leading principal investigators on clinical trials in the Mid-South, Dr. Arnold has more than 15 years of experience and has conducted 200 trials. She has led trials that have led to approval of well-known medications such as Ambien, Wellbutrin and Lyrica.
"Multi-site, double-blind, placebo-controlled clinical trials are the gold standard," Dr. Arnold said. "They are considered less influential. It's considered a high-quality study when the patients and the principal investigator don't know which patient is getting the drug and which patient is getting the placebo."
Typically, Dr. Arnold conducts clinical trials that are sponsored by pharmaceutical companies. She specializes in behavioral health and studies dealing with patients with attention deficient hyperactivity disorder.
"Safety is extremely important," she said, "We want to make sure the medication works and is safe for a patient to use. That is why we do trials in a controlled environment."
In addition to safety, clinical trials result in patients being offered better medication options.
"Clinical trials are important, especially in mental health, because we can improve efficacy and side effects in newer medications," said Dr. Anita Varma, MD, a psychiatrist and principal investigator for Research Strategies of Memphis. "Often times patients who are on older medications are not able to function as well because the side effects could add to other health issues. Newer medications may make a patient feel better and more able to function. We are able to inform the patient there are other medication options.
"It's important to understand that mental illness is treatable," Dr. Varma continued. "We want patients to feel better. Medication compliance in clinical trials is highly important in mental health. It's through clinical trials that we can offer more treatment options and improve side-effect profiles so patients can function better. We've been seeing some newer medications have less side effects."
Dr. Arnold said a double-blind study helps create a neutral environment because neither the patients nor the medical staff knows which patients are taking a certain drug and which patients are receiving a placebo.
Medical staff must be trained on how to talk with a patient so they don't influence or change a patient's perception during a trial.
"You have to be careful because the smallest influence can damage a trial," Dr. Arnold said. "I just got out of a meeting which discussed how pre-programmed after-hours phone messages can influence a patient. These are small things people don't even think about, yet how we word something makes a big difference."
Dr. Arnold said she is seeing new trends that aid medical staff in creating a consistent, controlled environment.
"We are utilizing more technology," she said. "Over the last couple of years, companies have required us to video our interactions with patients. We are given feedback from medical experts to make sure that our treatment and wording is consistent."
Dr. Arnold said she will have experts who deal with certain illnesses such as post traumatic stress disorder or obsessive compulsive disorder assist in monitoring patients and give feedback.
Additionally, she said she is conducting more genetically influenced studies where companies are looking for specific genetic markers in patients to find out how certain medications respond to them.
According to the National Human Genome Research Institute, which is a government research entity that funds genetic and genome research, pharmacogenomics is still in its infancy. Pharmacogenomics, the study of how genes affect a patient's response to drugs, is a more personalized approach to using and developing medications.
According to Dr. Arnold, one of the most important processes, and the most challenging for physicians, is choosing the right patient for each trial.
"There is not one simple diagnosis," she said. "Some patients many have several diagnoses and you have to make sure they will benefit from the study."
Dr. Arnold said it's ideal to have patients from various sources and different geographic locations, as it increases the chances to get the best sample of patients.
"It's important to have different sites because you typically get a better sample this way," she said. "If you don't have multiple sites, it could adversely affect a study."
She added that it's not uncommon for some trials to be conducted at 25 different locations.
Multi-site selection in a clinical trial is so important that the University of Tennessee Health Science Center has announced a plan for a new initiative that could bring more clinical trials to Tennessee and result in more research grant money for the state and UTHSC.
Dr. Steven Goodman, Ph.D.
According to Dr. Steven Goodman, Ph.D., vice chancellor for research at UTHSC, university clinical faculty conduct many clinical trials at various hospitals throughout Tennessee, yet the university doesn't receive credit for the trials because they are conducted at hospitals the institution doesn't own. As a result, UTHSC doesn't receive additional research grant money.
"We estimate that we aren't getting $30 million of grant money for research that we would otherwise if the university was receiving credit for these trials," Dr. Goodman said. "Our faculty is doing the work, but the university isn't getting credit for it."
Goodman presented an idea to Dr. Steve Schwab, MD, chancellor of UTHSC, to create a 501 (c) (3) organization through the University of Tennessee Research Foundation. Identified as the Clinical Trials Network (CTN2), it would provide that any clinical trial that is conducted by a UTHSC faculty member will go through the subsidiary of the foundation and give UTHSC credit for the clinical trial. CTN2 will provide personnel for the trials at the hospitals.
Dr. Schwab announced UTHSC's commitment to the endeavor last month at his State of the University address.
State hospitals and health centers affiliated with UTHSC are Methodist University Hospital, Le Bonheur Children's Hospital, Regional One Health, West Cancer Center, Saint Thomas Health in Nashville, the University of Tennessee Medical Center in Knoxville and Erlanger Health System in Chattanooga.
"You can't get enough subjects from one health center for a clinical trial," Dr. Goodman said. "You need to have multiple sites to get a good sample."
He is in the process of having memorandums of understandings signed at each location and anticipates CTN2 will be up and running by January 2018.
Additionally, Dr. Arnold, who is director of child and adolescent psychiatry at UTHSC in addition to her role at CNS Healthcare, said the National Institutes of Health is considering UTHSC for a comparison clinical trial that will study the side effects of antipsychotic drugs in children and adolescents.
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