New to Clinical Research? Bringing the Clinical Research Opportunity to You
Your Right to Have Equal Opportunity
Bringing the opportunity to participate in clinical trials to you and your doctor is a necessity. You should have an equal opportunity to participate in the innovation that is clinical research, regardless of your proximity to a big city or research center. My passion in life is to help you discover the power of using clinical trials as an extension of your current health care plan, especially if you live in a rural area.
You should not have to travel hours on end only to be forced to navigate an enormous clinical research hospital or academic institution in the busy, hectic city. You should not be required to receive clinical trial treatment from a large, unfamiliar research team. You should have the ability to participate in a clinical trial that is close to where you live. You should be able to go to your local doctor where the faces and the environment may be more familiar.
My mother was diagnosed with Multiple Sclerosis in the late 1970’s. Right before she became pregnant with me and during a time when FDA-approved treatment options were slim to none. No cure existed and still doesn’t exist today. Since my mother’s passing, over the years and through many conversations with my father, I have learned more and more about the struggles my parents went through to manage not only the Multiple Sclerosis (MS) but also her overall general well-being. He has pointed out, more than once, that her neurologist (one of only a few in the area) could not offer much more than palliative care (just trying to keep her pain-free).
Treatment options were restricted to one product that was new to the drug market and didn’t work for my mom. Other than one medicine, treatment was limited to clinical research of which there was none within a four-hour radius. This wasn’t due to a shortage of willing doctors near us, per say, but more so because of an industry that believes research should happen in large, metro hospitals and academic institutions.
Clinical Research as a Care Option
Using clinical research as an extension of my mother’s health care was an option, albeit the last option. My father vaguely remembers learning of and my mother participating in a clinical trial all the way down in Florida. Researchers had been testing venom-based therapy in human volunteers. He remembers that although the treatment seemed to work for my mother, it was never FDA-approved, and the clinical trials subsequently ended in the United States. Research continued outside of the US, and to continue my mother’s access to this in-development treatment, my parents would be looking at frequent travel to Mexico. We were middle-class; travelling to Mexico, unfortunately, was not an option at the time. We piled into the car and drove from Florida, back to northern New York State. Air travel, and travel in general, was not as easy or as common as it is today. All our traveling was done by car.
My father recollects there was also a clinical trial involving hyperbaric oxygen therapy. This trip to Florida I can remember parts of; I clearly remember the receptionist welcoming us to the clinical research site each morning of my mother’s treatment. I remember her hair short, dark hair and colorful make-up. She wore bright, boldly colored dresses and was sincere and friendly. The importance of a warm, welcoming clinical research team is vital to not only the patient’s experience, but also the experience of those who accompany the patient. Even though we were far from home, the staff helped us feel at ease by genuinely caring for both patient and family.
We could visit with my mother while she was undergoing the experimental treatment. I have images of my mom on a hospital bed, encapsulated by a clear, hard-plastic tube. I don’t have memory of voices, but I do remember my mother’s bright smile and happy face looking out from the clear plastic tube. She was at ease. And my mother’s smile, along with the friendly clinical research team, gave me comfort at a time when I had no idea why my mom was not able to lead a normal life. My mother experienced the benefits of oxygen therapy; however, this treatment at the time was only available through clinical research, of which wasn’t available in our home area.
Treatment options for MS progressed as slowly as information communication traveled in the 1980s: very slow. It wasn’t until the 1990’s, when internet became popular, that treatment development become more progressive. In 1997, the FDA signed a law requiring an information source for certain clinical trials to become publicly available. On February 29, 2000, ClinicalTrials.gov was launched. Even though the website included mainly government studies, it was a way for the public to begin to take charge of their care and for doctors to become better educated in the availability of clinical research for their patients.
Unfortunately, during this time, my mother’s symptoms progressed too rapidly over the years and she passed in 1999. The treatments that had subsequently received FDA approval were only approved because of the availability and completion of clinical trials. If there were no clinical trials, there would be no new treatment. Although a database exists and did received the Innovations in American Government Award in 2004, it is driven by government regulations. But it is time to change the reason why clinical trials are published to ClinicalTrials.gov. Trials are not only an FDA requirement for approval, they are also a way for the population to receive next-generation treatment at little to no cost.
A Focus on Accuracy and Accountability
Information about clinical trials gets loaded into ClinicalTrials.gov by the clinical research team. Sometimes information about the research location ends up incomplete and/or inaccurate. For example, a zip code was entered wrong or a research facility name was entered incorrectly. This creates a negative experience for you as the potential patient, because you are unable to find complete and accurate information about research sites. Until TrialScout, there was no accountability from either the pharmaceutical or government research sites that submitted partial, incorrect, or complex study information descriptions.
TrialScout is a website that focuses on taking the research site information provided to ClinicalTrials.gov and turns it into a format that is easy-to-understand and navigate. The mission of TrialScout is to transform the experience of finding and participating in clinical trials. Once you find a clinical trial on TrialScout, you can contact the site directly to have your questions answered and to gather any other information you may need to decide on your participation. Next, you can go to the research site in person to talk more about the clinical trial and to sign an informed consent form if you decide to participate. Once you sign the informed consent form, your participation in the study begins. Before TrialScout, when your clinical trial experience ended, it was over. With TrialScout, your experience and feedback are valued and sought.
TrialScout also offers you, the patient, the ability to rate and review your clinical trial experience. You can now share your feedback about important topics like: How long did you wait? How well did the medical staff listen? How was the office environment?
It is time for clinical trial participants, like you, to express and share your voice in a supportive and engaging environment. Clinical trials are a care option. Everyone should have the same opportunity to participate, rate and discuss the experience of being a part clinical research.
Written by Amy Rochford
Amy is a data analyst and self-described jack-of-all-trades at TrialScout. Amy is a transplant who moved to Buffalo three years ago, bringing experience from multiple industries including clinical trial operations, physician office management, and travel and tourism management. Amy’s time is consumed by her husband, two young boys, two dogs, and many foster dogs.