The personal impact of clinical research ::

The personal impact of clinical research ::

This article was written for our sponsor, NCBiotech.

Clinical trials are invaluable to the discovery of new drugs and treatments. From treatment of low iron stores to lung cancer, clinical trials help address a wide range of medical conditions. These research studies involve people affected by the conditions and are run through phased approaches.

In her position as a senior project manager at PharPoint Research, Inc. Dr. Elzbieta Maddock supervises all aspects of a clinical trial, from the proposal state to submitting final deliverables to the pharmaceutical or biotechnology client.

“We do everything related to making sure that the drug is working and is safe to use, from pediatrics to geriatrics, from infectious diseases to psychology — you name it, everything that still needs to have a new drug or treatment,” said Maddock. “These trials are actually required by regulatory authorities. They will not approve a drug that is not proven safe or reasonably safe. Everything needs to be completed according to FDA requirements in the U.S.”

If a safe dose is found during the first phase of clinical trials, it will move to the second phase of testing. More patients are enrolled in these trials in which the safety and efficacy of the treatment is studied. Phase three brings even more trial participants, comparing the new treatment with the current treatment to determine if the new treatment is better.

While Maddock works for a clinical trial management company, she also has personal experience with their impact. Her granddaughter, who was born with severe combined immunodeficiency, participated in clinical trials to help identify potential treatments. While the typical treatment for this condition involves a bone marrow transplant, Maddock’s granddaughter wasn’t able to find a match.

Instead, she underwent treatment at a small clinical trial in Los Angeles.

“It’s a genetic disorder that results in the complete absence of immune function. Without treatment, these children usually pass away by the age of two because of simple infections — even the simple flu virus can kill them,” said Maddock. “When my granddaughter was 10 months old, she was very fortunate to undergo gene therapy at UCLA in a small clinical trial that had around 15 patients. This was the first trial for this specific treatment, and she was patient number five. That gene therapy was very successful. She did have some complications from jump-starting her immune system, but this was managed over the next year.”

“Now, she’s a very active and healthy second-grader in the public school system. My entire family feels enormous gratitude for her results, and we are all indebted to the clinical trial system that allowed her participation and to have a chance for a normal life.”

As part of her continued treatment, Maddock’s granddaughter still completes follow-up visits at a children’s hospital in Washington, D.C. Being involved in clinical trials allowed her access to modern treatments that she might otherwise have been unable to obtain.

While not all clinical trials guarantee a cure, many allow for relief and symptom management, improving the quality of life of patients and bringing some much-needed hope to them and their families.

“What medicine is doing now is incredible — it’s like magic. It’s unbelievable what we can do. We might not see all the benefits of the clinical trial, but even if a trial cannot provide curative treatments to the patients, they still offer the opportunity to contribute to the advancement of the medicine,” said Maddock. “When patients sign up and sign the consent form, they know they aren’t paid. Still, we know that each patient who participates is aware that they contribute to the greater good of humanity.”

All data collected from clinical trials plays an important role in further research, and while that research may not occur immediately, it could be invaluable in the years to come.

For those interested in participating in clinical trials, there are websites open to the public such as CenterWatch and Clinical, the official government database run by the United States National Library of Medicine at the National Institutes of Health. For those in the Triangle, having state-of-the-art facilities like Duke and UNC Health Systems open up new opportunities to participate, as well.

For Maddock, her personal and professional experience only further drive home the importance of participating in trials.

“I don’t think I’m exaggerating when I say that all departments at a big system like Duke are running at least one current clinical trial. Physicians have access to these trials and can inform their patients of those that might potentially benefit them,” said Maddock. “It really means the world to me that I am in this field. We know that very often we can change someone’s life. Even if we can change one person’s life, that’s immense.”

This article was written for our sponsor, NCBiotech.

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Kassie Hoffman
Kassie pens down all the news from the world of politics on ANH.