Exploring New Frontiers in Patient Care

Clinical Trials Offer Opportunities for New and Innovative Health Care Interventions

• By Mark Hendricks
• May 22, 2025
• Research

Before it is approved and made available to patients, a new drug, medical device or treatment procedure is subjected to a clinical trial, a type of research study that tests its effectiveness and safety in human participants to determine if the new intervention improves upon existing standard-of-care treatments.

“Clinical trials are the future of medicine,” Jenna Kesey, Ph.D., said. “Every medication we have on the market right now that is used to treat high blood pressure, diabetes or whatever disease or condition that you're dealing with was at one point in time subjected to a clinical trial.”

Kesey, associate managing director for the Clinical Research Institute (CRI) at the Texas Tech University Health Sciences Center (TTUHSC), said it's important that the university provides opportunities for its patients to have access to innovative therapies through the clinical trial process. These opportunities are not available at all medical centers.

“To me, clinical trials give patients an opportunity to participate in cutting-edge medicine because a clinical trial is part of the process of an intervention becoming the future standard of care,” Kesey said. “Everything we know to be a current standard of care started with a clinical trial. In my opinion, if a patient is struggling with a difficult to treat diagnosis or complex condition, we want to be able to offer the option of an emerging and innovative therapy.”

Offering those types of options is at the core of the CRI’s mission to promote and facilitate clinical research for faculty and trainees while upholding the highest standards of excellence. Throughout each clinical trial, the CRI assures the research is conducted ethically, responsibly and professionally.

As a principal investigator (PI), Leslie Shen, Ph.D., a pathology professor, associate dean for research and founding director of the School of Medicine’s Center of Excellence for Integrative Health, has received funding from federal and industry agencies for investigator-initiated clinical trials, including U.S. Food and Drug Administration (FDA)-Investigational New Drug (IND) trials. She works closely with CRI regulatory staff for all Institutional Review Board (IRB)-related regulatory administration and with CRI study coordinators for all participant-related tasks.

“CRI is a great resource for the PI who can’t afford a full-time study coordinator but needs a wide spectrum of assistance in all clinical trial-associated tasks,” Shen said. “In addition, CRI provides internal auditory service to monitor on-going clinical trials, which is a plus to our research team to make sure we follow all regulations. Also, because of the CRI, our research team was able to receive funding to conduct an FDA-IND trial with high integrity and scientific merit.”

So how do patients join a clinical trial at TTUHSC? Kesey said the easiest way to enroll is by visiting the CRI website (https://app4.ttuhsc.edu/CRIVolunteer/) and filling out a brief form indicating interest in future clinical trial participation. The CRI has an ongoing list, and patients can select the types of clinical trials or disease processes in which they may have interest.

The second way to participate is to discuss the clinical trial with one’s TTUHSC health care provider. Part of the CRI’s process in setting up clinical trials is identifying possible participants. However, CRI (or TTUHSC) personnel do not and cannot randomly contact people and ask them to participate. Kesey said that goes against TTUHSC’s policies and professional ethics. If the clinical trial is addressing a specific disease or condition, then the primary investigator for the clinical trial may offer participation to their affected patients during a scheduled appointment.

“If I'm taking care of a population of people that have a disease — let's say hepatitis — then as a practitioner, I'm going to be interested in clinical trials that treat hepatitis because I want to have a therapy available for my patients,” Kesey explained. “So the principal investigator, in their role as a faculty provider, would offer this to their patient population.”

The CRI supports two types of clinical trials, the first of which is investigator-initiated trials where the investigator-practitioner has their own clinical trial idea. Based on their expertise, experience and training, they develop a plan to investigate something happening in their patient population, or they might come up with their own idea for using a drug, a device or an intervention that TTUHSC can provide for patients. 

Investigator-initiated trials also may be grant-funded, which means investigators apply to federal agencies for grants (e.g., the National Institutes of Health) or one of the many other external clinical trial sponsors. For these clinical trials, Kesey said a practitioner may have an idea to help improve the lives of their patients. After a long application process, and if the grant application is successful, the external entity agrees to fund the clinical trial.

“Grant-funded clinical trials are generally considered to be investigator initiated; the difference is the PI secured the funding,” Kesey said.

If necessary, Kesey said the CRI can work to obtain approval from the FDA. If it's something that's already been FDA approved and the TTUHSC investigator proposes to use it differently to care for their patients, then the investigator can start their own interventional research study. 

“We talk to patients about the research, and then they can choose to be a part of the study or not,” Kesey said. “If they do opt to participate, they will receive the intervention or experiment and we track the progress to see if it helps. Sometimes there is external funding associated with that, but not always, and we have a lot of investigator-initiated research happening because we have a lot of brilliant researchers here at TTUHSC.”

A second type of clinical trial supported by the CRI is an industry-sponsored (or contract-sponsored) clinical trial. These typically are sponsored trials where someone from a company or industry has developed a pharmaceutical drug, medical device or an innovative way to treat a specific disease they believe can improve outcomes for patients.

Because pharmaceutical companies don't have patients, Kesey said they will contact TTUHSC and the CRI because of the large patient population served by the university. The CRI evaluates the device, medication or procedure for any potential benefits to patients and to ensure TTUHSC has a sufficient patient population for conducting the trial.

“If it's a good match for our patients and meets our internal policies and standards, then we will negotiate an arrangement to conduct a clinical trial,” Kesey said.

Regardless of which type of clinical trial is being considered, the CRI works with the investigator to find funding because clinical trials are expensive endeavors that can take many years to complete. Kesey said the process includes working with the FDA to ensure investigators adhere to the maximum checks and balances designed to enhance patient safety.

“The FDA has to be made aware in advance before we can set up a clinical trial,” Kesey said. “We have to prove that we have safety measures for each clinical trial phase before we’re ever allowed to enroll a human participant. It's a lengthy and expensive process; I think most people understand that for a new drug or device to go all the way from discovery to treating patients takes many years. We would never give anything to a participant that the FDA doesn’t believe to be safe.”

In addition to FDA approval, Kesey said all clinical trials must be logged through ClinicalTrials.gov, an NIH website and online database that includes all clinical research studies and their results. The database is a good source of clinical trial information that can be accessed by researchers, health care professionals and the public.

TTUHSC also has internal safety checks and requirements that are continuously tracked and evaluated by its IRB. Kesey said the IRB ensures the protection of human subjects that might be participating in TTUHSC research, including clinical trials, by acting in compliance with federal regulations as well as under its accreditation by the Association for the Accreditation of Human Research Protection Programs.

“This is a federal requirement and an incredibly important safety check that we have in place to ensure that everything is above board and we are putting patient safety at the absolute pinnacle of our clinical trial planning and execution,” Kesey emphasized. “Patient safety is always the most important thing.”

Whether a patient agrees or declines to participate in a clinical trial, Kesey said the level of care they receive from TTUHSC will not be affected, and they will never be forced or coerced into participating. Either way, TTUHSC will always provide the patient with an evidence-based standard of care recognized as the best way to treat their disease process. Clinical trials are just another way for TTUHSC to offer treatment for a disease or condition in a new and innovative way not yet recognized as the standard of care.

All TTUHSC providers practice evidence-based medicine, but a patient may be frustrated with how their disease treatment is going, or they have a difficult-to-treat disease such as a specific type of cancer and they’re frustrated because they are not improving. In those cases, Kesey said they may want to consider a clinical trial. And if they decline to participate, they will still get the same great care that any TTUHSC patient receives.

“Accepting or declining a clinical trial opportunity doesn’t change a patient’s relationship with their physician, and it doesn't change the fact that we're going to take great care of you,” Kesey insisted. “It's just one of the options we offer our patient population to make sure we're giving them an opportunity for a whole gamut of treatment options and not just standard of care.”