Uncategorized Archives - High Point Clinical Trial Center
 

Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) are looming epidemics and currently the intense focus of the academic, pharmaceutical and medical industry.

Dr. Margarita Nuñez, Medical Director/Principal Investigator at High Point Clinical Trials Center, elaborates on this epidemic and how reaching out to the community is a crucial component of tackling this growing issue.

Dr. Margarita Nunez, Medical Director

As Dr. Nuñez shares, there have always been concerns with the complications that come with diabetes, but one of the common issues that went undiagnosed for a while—even in clinical settings—was an elevation in patients’ liver enzymes.

“Over time, experts in the medical field began to recognize the damage to the liver that comes from and is caused by metabolic abnormalities. It used to be assumed that individuals with abnormal liver enzymes were “closet drinkers.” However, a number of patients would never drink at all, which led experts to further investigate liver damage and its connection to diabetes and metabolic disorders,” she explains.

Dr. Nunez continues “Initially, when presented with a patient experiencing damage to the liver, doctors would typically use an ultrasound to check for illnesses like Hepatitis, but in several cases, they often assumed it was a viral issue. Now, doctors and researchers have since been able to identify this condition as Non-Alcoholic Fatty Liver Disease (NAFLD) that can progress to Non-Alcoholic Steatohepatitis (NASH) and even Cirrhosis. NAFLD is described as fatty infiltration of the liver without evidence of inflammation, whereas NASH refers to fatty infiltration of the liver with the presence of inflammation.”

“It is imperative to understand that NAFLD and NASH are conditions that cannot be taken lightly. The damage to the liver is a real medical problem that in many cases can be life threatening. What is even more alarming is that victims of this disease typically do not even know they have it—in fact, it can go undetected for years. Therefore, bringing awareness to the condition within the community is of utmost importance.”

So, what is the best way to treat people who have this underlying liver damage?

Dr. Nuñez points out, “Like many metabolically related diseases, the current recommendation is lifestyle modification. However, while poor dietary choices and lack of exercise heavily contribute, there is evidence to suggest underlying genetic factors could affect metabolism of fats and lipids, leading to the accumulation of fatty deposits in the liver.”

Therapies are under development for both diseases, but currently there are no approved drugs to treat them. So, for now, the major effort must be directed towards patient education, and most importantly the positive impact that can be made through early diagnosis.

Dr. Nuñez emphasizes, “It’s really important to identify the problem even if there is no cure. Realistically, there is something you can do to make a difference. You can change your lifestyle and try to improve your parameters. Patients with this condition could also be entering into research to potentially help people in the future or they could join a clinical trial for possible treatment.”

NAFLD affects anywhere from 6-35% of people in the United States and refers to the presence of fat after other causes for secondary fat have been ruled out, including heavy alcohol use. Risk factors for this condition include obesity, Type 2 Diabetes, Dyslipidemia and Metabolic Syndrome. NASH, on the other hand, affects approximately 3-5% of people in the United States, diagnosed by hepatic inflammation via biopsy or fibroscan, or a confluence of other non-invasive metabolic parameters.

High Point Clinical Trials Center (HPCTC) works in the North Carolina and more specifically the Piedmont Triad region to help the community understand NAFLD and NASH or its emerging stages. Dr. Nunez explains, “We have been developing a screening initiative to invite people who are concerned about NASH or potential liver injury to come in, and we will do some basic tests and discuss the results.”

In addition to the screening initiative, HPCTC’s medical staff volunteer at the Community Clinic of High Point to help identify patients who could benefit from intervention and bring awareness to the problems they are encountering. The center has also recently launched a 33’ Recreational Vehicle (RV), “health center on wheels,” designed to support a wide range of screenings and bringing mobility to the outreach effort by expanding the bandwidth to the entire Triad region and beyond.

These initiatives are a critical first step in the journey towards raising patient awareness and helping advance promising new therapies to the market.

 

   

In a recent blog the very important role of the Principal Investigator was described and we provided information on what clinical research is. Beyond their day to day involvement at High Point Clinical Trials Center, Physician Investigators, Dr. Jonathan Austin and Dr. Mark Pearson, are also involved in the community and have participated in other volunteer medical initiatives both domestically and overseas. These activities not only provide healthcare services to the medically underserved but they serve as an educational opportunity where Patients learn about clinical trial research and evolving new therapies.

Dr. Mark Pearson MD, Sub-Investigator

Dr. Jonathan Austin MD, Principal Investigator

Dr. Austin and Dr. Pearson have been adamant about participating in community-based medicine and supporting Patients who may not have the financial resources to access primary and preventative medical services otherwise. For example, their involvement at the Community Clinic of High Point (CCHP) allows them to offer care in an outpatient setting to those with acute or chronic medical conditions and limited means of accessing healthcare. Patients with little or no insurance and low income are treated at CCHP by an expert group of volunteer physicians from all walks of medicine who generously donate their time and skills to make a difference in the lives of their neighbors.

Dr. Austin has initiated a screening program for evaluation of Chronic Obstructive Pulmonary Disease (COPD) in Patients by symptom driven surveys with state of the art spirometry assessments. Additionally, he has also teamed with iCardiac, a leading core laboratory for cardiac safety testing. Their cardiac technology will enable high quality bedside EKGs to be obtained from Patients along with iCardiac’s cardiologist assessments to guide subsequent Patient care.

Dr. Pearson has volunteered overseas doing medical and surgical work at a Missionary Hospital In southern Nigeria for several years, then moved to and worked doing Medical outreach and education for 6 years in northern Haiti from 2000 to 2006. He also recently completed a Fellowship at LSU, New Orleans in Undersea & Hyperbaric Medicine and Wound Care.

The importance and benefits of clinical research have been demonstrated repeatedly and across several therapeutic areas. Experimental therapies have provided tangible benefits to Patients suffering from debilitating and chronic conditions and the involvement of physicians within the community is important to provide Patients with the necessary information and address their questions first hand as to what clinical research is and how it can potentially benefit them.

Only by giving back to our community and sharing opportunities for Patients to benefit from clinical research can the progress in both novel treatment development and Patient care continue.

 

 

   

 

When I first saw the abbreviation “PI” I paused to think what or who is a PI?–private investigator, physician investigator, personal injury lawyer?  I came to find out that “PI” in the clinical research world stands for Principal Investigator.

In terms of the major players in a clinical research trial,  principal investigators assume ultimate responsibility  for the conduct of a clinical research study.  That being said, an investigator cannot be in all places at all times so research tasks may be delegated to research staff and the investigator must maintain oversight for the conduct of those to whom they delegate these duties.  Again, they are responsible for the ethical conduct and supervision of the trial and will protect the rights, safety and welfare of the volunteers.

Also, an investigator ensures that research volunteers are informed of a study appropriately and that they are aware that the study treatment is being used for research purpose–this is known as informed consent and follows a continuum throughout the study.   If any changes are made to the study protocol, it is the responsibility of the PI to fully inform the volunteers of these changes and offer an option for them to discontinue the study if they wish.  Furthermore, the  PI is the voice for the research site when there are patient care issues that warrant notification of the sponsor or ethics committees (IRB).  .  Again, the rights, safety and welfare of the research volunteers are the number one priority of the investigator.   Medical assessments, efficacy evaluation of the research drug and determining whether the therapy is related to adverse events are further commitments of an investigator. Finally, transparency in terms of providing accurate data are yet another important duty of the PI.

Who can become a PI? 

An investigator does not necessarily have to be a physician or PhD in a particular field, but should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial.  However, the medical care given to, and medical decisions made on behalf of, subjects should  be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.  In terms of experience, the principal investigator should be well versed in the principals found in the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) as well as FDA regulations regarding clinical research.

 

 

   

 

Hello
My name is Jonathan Austin and I am a principal investigator at High Point Clinical Trials Center.  My background is in emergency medicine but I am now fully involved in clinical research here in High Point, North Carolina.

What is clinical research or clinical trials and why would you want to participate?

Clinical trials are part of and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of a clinical trial is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

The idea for a clinical research study — also known as a clinical trial — often originates in the laboratory. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.  A clinical study is led by a principal investigator like me.  My number one priority is the safety of our subjects and running a study takes many skill sets, but I aim to manage all studies with the highest ethical and quality standards.  Also, principal investigators lead the other members of the research team who regularly monitor the participants’ health to determine the study’s safety and effectiveness.
Being involved in clinical research allows me to have a greater awareness of cutting edge therapies and the ability to access new treatments or medial alternatives that may only be available through clinical trials..  Here at  High Point Clinical Trials Center, we all play a role in bringing potentially new treatments to the public  that may ultimately impact the healthcare of many patients in the future–it has been said that  today’s standard treatments were yesterday’s clinical trials.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

Clinical research is medical research that involves people like you.  People volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Clinical research includes trials that test new treatments and therapies as well as long–term natural history studies, which provide valuable information about how disease and health progress.

Clinical research trials are a key component of the the drug development process.  More than 1400 medications and therapies have been approved through this process that helps treat or prevent serious disease or illness.  The importance of subject participation cannot be understated and will make a difference in the lives of many.  There is some personal satisfaction in knowing that I can offer this to the pubic as well, and it’s encouraging to know that we are increasing the community’s options for new treatments by bringing state of the art science to where we live (here in the Triad).