Clinical Trials Day: A History of Fostering Clinical Research

Today is Clinical Trials Day, an international day of recognition for the scientists, study teams, and volunteers that make new health care discoveries possible. Clinical Trials Day is celebrated on May 20th each year in honor of the start of what is largely regarded as the first clinical trial.

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British warship similar to the one on which James Lind conducted the first clinical trial.

On May 20, 1747, a surgeon in the British Royal Navy, James Lind, randomly assigned 6 pairs of sailors afflicted with scurvy to a variety of dietary regimens. Scurvy, a vitamin C deficiency, is characterized by fatigue and bleeding gums and was common among sailors, who had little access to fresh fruit on long voyages. After 6 days on their special diets, only the sailors who were given oranges and lemons showed drastic improvement.

The idea to use citrus fruit for treatment of scurvy came from centuries of prior knowledge – dating back to Vasco De Gama’s expedition to India in 1497. However, the British Royal Navy didn’t adopt the use of citrus juice on ships as common practice, until 40 years after Lind published his results.

The story of Lind and the history of scurvy demonstrates the many roadblocks between scientific discovery and improving the health of a population. Some of these same roadblocks exist today – though, thankfully, to a lesser degree. While it may no longer take centuries to develop new ideas into life-saving therapies, it still can take several decades.

The CTSI is built around breaking through those roadblocks and facilitating scientists in moving their work forward. The institute offers services and guidance all along the spectrum of research, including the design and implementation of clinical trials, which are much more complicated and sophisticated than Lind’s rudimentary trial.

“It’s great that we have a chance at the University of Rochester to go from the inception of the idea to actually have patients coming to be evaluated [in a clinical trial],” says Giovanni Schifitto, MD, MS, Director of the Clinical Research Center and professor of Neurology at the University of Rochester Medical Center. “It’s a full circle.”

The Clinical Research Center (CRC) is an essential resource for the implementation of clinical trials offered by the CTSI. The CRC offers a safe and comfortable place for patients and study volunteers to receive treatments and employs a dedicated, knowledgeable staff that is vital to its success.

“Clinical research is very important and the research nurse is at the forefront of the process,” says Ann Miller, RN, MS, CCRC, nurse manager of the CRC. “The CRC nurses have skill sets that range from neonate to geriatric experience. In conjunction with the Bionutrition staff, Imaging Sciences, and Health Project Coordinator we benefit, and enhance, each other’s knowledge base and I think that’s been very helpful.”

Moxley CRC

Richard Moxley, MD utilizing the Clinical Research Center.

In addition to traditional nurse training for the hospital, the nurses of the CRC are required to undergo continual specialized training to keep them up-to-date on best practices in clinical research and to give them a solid understanding of each of the studies they facilitate. Each investigator that wishes to utilize the CRC must give an inservice training to explain the science behind the study as well as detailed information about what the CRC staff will need to do, when, and why, with the overall goal of making the CRC an integral part of the investigating team.

 

The CRC commonly carries over 100 studies at once. Right now, they are implementing around 80 clinical trials that aim to cure, prevent, or better diagnose 35 different diseases. From understanding the cause of cognitive decline in HIV patients to testing new drugs for rare, debilitating diseases like Duchenne Muscular Dystrophy, the CRC staff is integral to a process that offers hope not only to their study participants, but to millions of people suffering with these diseases around the world.

“We are lucky,” Schifitto says, “to have a resource like the CRC. There are institutions that don’t have such a resource and therefore cannot do certain studies.”

Schifitto also points out that the CRC is just one clinical trial resource offered by the CTSI. While the CRC aids with the implementation phase of a trial, the CTSI also offers help with designing trials, developing helpful collaborations, navigating regulatory processes, recruiting the required amount of participants – especially from populations that are typically under-represented in clinical research, training and providing study personnel, and the collection and management of clinical data.

The CTSI is also affiliated with the Center for Human Experimental Therapeutics (CHET), which was established to conduct rigorous initial investigations of new therapies for musculoskeletal, cardiovascular, neurologic, infectious/immunologic disorders and cancer. CHET facilitates initial clinical trials from many disciplines around the URMC – from vaccines being produced by the infectious disease program to innovative therapies for cancer being tested in the Wilmot Cancer Institute.

All of the resources provided by the CTSI help researchers take their ideas from the laboratory to the clinic and help put URMC at the forefront of biomedical research.  With these resources, our dedicated researchers strive to cure debilitating diseases and improve the lives of the millions of people suffering around the world.

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