Without clinical research trials, many of the lifesaving medications available today simply would not exist.
Clinical Trials Research (CTR) is destigmatizing the process for research volunteers, who may fear becoming “Guinea pigs,” by providing individualized care and education along the way and minimizing risk to patients.
“The number one concern is do no harm,” said Robyn Lawrie, a nurse practitioner at CTR. “We would never do anything to ever hurt you.”
Since 2000, CTR studies have helped approve more than 200 medications with the help of over 1,000 patient volunteers, and the clinic has maintained its reputation for quality care and volunteer attention.
Early Research Minimizes Risk
Before volunteers can enroll in a CTR research study, the medications and treatments – and the volunteers themselves – must go through an in-depth vetting and testing process to ensure everyone’s safety.
“There is a perception by the public that they are Guinea pigs when they participate in a clinical trial,” said Dr. Jeff D. Wayne, CTR’s principal investigator. Lawrie added that at CTR this is definitely not the case: “We already know there is a certain safety profile with this medication, because it’s already been through some phases of study.”
CTR only collaborates with well-known pharmaceutical companies, Contract Research Organizations (CROs) and Institutional Review Boards (IRBs) to initiate and complete innovative research studies.
Each of these organizations abides by specific protocols, and CTR closely monitors volunteers through each step of a clinical trial.
When Charles Davidson began a CTR clinical study for diabetes, he said that while his primary care doctor just prescribed him drugs, the staff at CTR gave him personal guidance and stress-management skills to help treat his illness beyond medication.
“The staff here is great,” he said. “They became like family for me, because I was checking in with them every week. And the conversation was never just ‘How are your numbers? What’s going on?’ It was ‘How are you doing?’”
Lawrie herself has been fighting diabetes for a decade, and she makes a point of sharing her personal experience with patients. “I think my patients appreciate the fact that I share with them my own personal experience,” she said. “They can take that and say, ‘If she can do it, so can I.’”
Benefits Beyond Treatment
When it comes to finding potentially life-saving medications and treatments in clinical research studies, the patient is as important as the investigator.
Some clinical trial benefits are well known, including access to medications at no cost and compensation for time and travel. But perhaps the most life-changing benefits are the less-apparent ones, including invaluable education and information, and eye-opening medical consultations.
“(Volunteers) know they are going to get something when they come here, not just a medication, but they are going to get education,” said Lawrie. “They are going to learn about their disease. They will learn to take ownership of their disease. We’re able to take one particular area the patient is concerned about and really spend a lot of time (with them) – not just seven minutes, but hours if I want to.”
Volunteers also benefit from knowing their clinical trial may ultimately change the lives of many people who suffer from the same pains, if the medications are eventually approved.
“There’s just a caring environment here,” said Davidson. “It’s funny, we’re all given a number in the study to protect our anonymity. They knew me by name, and they would always call me by name, but anytime they needed to see my chart or my records, they forgot my number. So, literally, I was not just a number to them. I was a person that they cared about.”
CTR clinical research aims to help people who suffer from a wide range of ailments, including diabetes, high blood pressure, kidney disease and depression. The clinic’s studies’ effects are far-reaching and have been life-changing for people all over the world – especially at home in Sacramento.
“When patients deal with larger research companies, they really can get lost in the system,” said Wayne. “With our research program, we pay attention and we give people individual care. We really do care about people.”
