News

GRID VIEW

No more posts
Limey.jpg

On a sailing ship in 1747, twelve sailors who had begun the voyage feeling fine were overcome with fatigue.  Their gums were swollen and sore, making it difficult to eat.  Their teeth were falling out.  Their legs were swollen and purple from bruising.

 

Dr. James Lind was a passenger on that ship, and he set out to find the cause.  He set up what may have been the first clinical nutrition experiment.  He decided on six groups of treatments, 2 sailors in each group:

 

  1. drank one quart of cider a day
  2. gargled with sulfuric acid
  3. had two spoonfuls of vinegar, 3 times a day
  4. drank ½ pint seawater a day
  5. drank barley water
  6. ate two oranges and 1 lemon a day

 

Within six days, the sailors who ate the oranges and lemon felt better and were able to work again.  The other sailors in the experiment felt worse.  The ill sailors were suffering from a lack of vitamin C, now known as Scurvy. They had plenty of fresh fruits and vegetables when they first set out on the voyage.  But fresh foods ran out on the long voyage, and they suffered symptoms from this lack. After this finding, sailors often brought lime juice aboard ship because it could be stored longer. This is how sailors earned the nickname “limey”.

 

1747 was well before the requirement of informed consent of the patient, detailed eligibility criteria, protocols and regulations, which are a foundation of today’s clinical research.  Nevertheless, it is an interesting example of a method of discovering the best treatment for a disabling condition.

 

Scientific minds are still seeking solutions for medical problems.  Modern clinical research is strictly regulated for the safety and well-being of the research volunteer.  Great progress has been made in medical science over the last decades.  This progress could not happen without dedicated volunteers. Participation in clinical trials can be a rewarding endeavor for both investigators and volunteers alike.

 

Written by: Julia Baker, RN, CCRC

Resources:
https://askabiologist.asu.edu
https://www.umass.edu/nibble/infofile/limey.html

 

 

 


clinical-trial.jpg

December 12, 2018 BlogResearch in General0

Thank You for a Great Year!

 

As an ENCORE community member, we hope you have enjoyed hearing from us this year. Each month we strive to provide you with accurate information on health topics that are relevant to you and our enrolling studies. 2018 has been a momentous year for us and has seen complete many trials for novel medications that we believe will improve global health. We are thankful for dedicated volunteers like you that make this possible!

 

This month we would like to do something a little different and provide you with insight into clinical trials. A lack of clinical trial education is routinely cited as the number one barrier to enrolling trial participants. Clinical trials are required by the FDA to prove the safety and effectiveness of new medications and volunteer participants are necessary to complete these trials. We understand that this concept is often intimidating. However, there are several measures in place to make our trials as safe as possible, including:

  • Physicians in charge of all study activities
  • Pre-Clinical Testing
  • Institutional Review Boards (IRBs)
  • Informed Consent Forms
  • Routine Participant Labs and Clinical Assessments
  • Clinical Trial Data Safety Monitoring Boards

 

Investigational products are thoroughly studied during pre-clinical testing before the trials are designed and the first human participant is enrolled. Pharmaceutical companies spend millions of dollars to bring medications to market and they want to be nearly certain that the medication will fulfill its intended purpose. However, volunteers are needed to complete the FDA clinical trials. When designing the trial protocols, participant safety is always the number one priority!

 

Every trial is overseen by an Institutional Review Board (IRB). The purpose of the IRB is to protect the rights and welfare of human research participants. The IRB evaluates the possible risks and benefits of the trial before it is allowed to open. They are also responsible for approving the trial protocol and the informed consent. Along with the consent form, a discussion with our medical staff allows you to make an informed decision on whether or not the trial is in your best interest. Lastly, participants in the study are continuously monitored for safety and there are many tests completed during the trials to alert researchers at the first sign of potentially serious side effects. We hope that every patient that has worked with us has felt that it has been a safe and positive experience!

 

Thank you again for helping us improve global health and find new ways to treat medical ailments! 2019 is going to be another exciting year at ENCORE Research and we hope to get the chance to work with everyone reading this letter.

 

Happy Holidays,
ENCORE Research


Volunteers.jpg

November 12, 2017 BlogResearch in General0

Why do our volunteers want to participate in clinical trials?  Volunteers are often motivated by a combination of several reasons. Here are 6 of the top reasons to participate.

  1. The potential of finding relief from their symptoms

We can’t promise relief from symptoms due to placebo and efficacy of the medication being tested.  However, the Hawthorne Effect proves that patients who participate in a research trial have better outcomes than those not participating.

  1. To learn more about their condition

You might argue that to learn about a condition you can just look it up on the web, and we all do that.  However, often these websites can be misleading or provide the worst-case scenario results, which don’t apply to most of us. Another option is to ask your primary physician, and that is a good thing to do.  Unfortunately, physicians are often rushed or running behind and questions are forgotten.  Participating in a clinical trial provides you ample one on one time with a research professional and physician so that all your questions can be answered.

  1. Access to new cutting-edge treatments

When participating in a clinical trial, there is access to new cutting edge treatments that are not available yet to the public. There can even be access to medications that have been newly FDA approved, but are much too expensive to afford.  Study required medications are most often provided at no cost!

  1. Receiving medical care at no cost

Sponsors such as pharmaceutical companies, governments and foundations fund medical research through study grants. The grants fund local research sites for conducting the study so you don’t pay a thing.  In fact, we don’t even ask you for your insurance information!  Can you believe most studies compensate patients for time and travel?

  1. Making a difference

Clinical Trials help shape the future of medicine and healthcare.   Volunteer participation helps researchers discover more about health conditions and find better ways to treat them!

  1. Moral and emotional support

Having medical conditions that others don’t necessarily understand can make some people feel alienated.  When involved in research, support staff understand the patient’s condition and what they may be experiencing and can provide moral and emotional support.

We will do everything we can to help find a trial that is a good fit for interested volunteers.  New clinical trials are constantly enrolling so do not be discouraged if we don’t currently have the perfect trial for you.  The majority of volunteers who completed a clinical trial are interested in participating in another one, so call us and find out your reason to participate!

 


NON-QUALIFY.jpg

At ENCORE Research Group it is our mission to help every patient that walks through our doors qualify for the clinical trial of their choice. Often times we get to experience the thrill of telling our patients that they successfully qualified and will soon enroll in the study. However, this is not always the case and we understand our patients’ frustration when they decide to commit to a trial only to later find out that they do not qualify. Here at ENCORE Research Group we were curious how this situation affected their thoughts about applying for future studies. This month, curiosity got the best of us and we reached out to some of our community members to find out!

Thomas recently came to Jacksonville Center for Clinical Research (JCCR) to have an evaluation for a high triglyceride and weight loss study.  Fortunately for Thomas, he was not eligible for the trial because his triglyceride level was too low.  Thomas stated “it’s good that I am healthy enough not to be in this research study.  But they are looking at another study that I may be interested in.” As you can see, Thomas was not discouraged that he did not qualify, but optimistic that he may qualify for a different study.

We also reached out to Latasha, who is new to research, and may qualify for a study that has a waiting list for interested participants.  When discussing with her how some patients are not eligible to join a trial, she stated “I would want to know why I did not qualify, but that would not prevent me from trying to get in another trial.” Fortunately for Latasha and all of our participants, ENCORE Research Group is very transparent about the screening process and explains exactly why they may have been ineligible. Hopefully she will receive a spot in the study she applied for!

Mark was passionate about participating in a Sjogren’s research trial but did not qualify.  He said “it’s not unusual for someone with Sjogren’s Disease not to qualify for studies with systemic therapies if they do not have the antibodies. But when you’re sick, your driving force is to get better for yourself and your family.  I tried the conventional way but it did not work for me.”  After doing more research on the specific clinical trial, Mark decided to pursue the FDA Expanded Access program. “It’s a relatively new program to help people get access to new medications.” Fortunately for Mark, he had the resources and insight to look into alternative treatment options.

We also asked an experienced researcher how she saw things. Linda Gray, site manager of the Nature Coast Clinical Research site in Inverness, Florida, has many gastrointestinal (GI) studies currently enrolling.  Linda acknowledges that “some of our patients are not eligible for a study because they have mild disease, and the sponsors are looking for moderate to severe disease.  If the disease is not measurable enough for objective data, we will not be able to tell if we’ve reversed it or slowed the progression.  Our NASH studies include a liver biopsy to determine the extent of the disease to see if the patient is eligible.” It is unfortunate that this can limit access to drugs for those in need, but we have to believe that obtaining clear and objective data will help a greater number of people in the future.

The reality is, every clinical trial is different and has unique qualifying criteria. The pharmaceutical companies that sponsor clinical trials create the criteria in order to make the strongest case possible to the FDA on the drug’s safety and efficacy. While we would love to involve every one of our community members that are interested, it is just not always possible. The good news is that all seven of our research sites are always getting new clinical trials to enroll in! So, just because you didn’t qualify the first time doesn’t mean you won’t qualify for the next one! We look forward to working with you in the ENCORE community.

 

 


medical-excellence.jpg

September 1, 2017 BlogResearch in General0

The practice of medicine has changed in major ways in recent years. Though many of these changes reflect good intentions, the real world consequences to patients often don’t match expectations. To understand this divide between reasonable intentions and the less salubrious reality from which we may collectively suffer, I’d like to share a recent anecdote that occurred at the airport when regulations ran amok.

During recent travel, I witnessed an unfortunate incident that you may have seen before. An airline gate agent stopped a member of our party and reprimanded her for carrying a small overnight suitcase, a computer bag and her pocketbook. The gate agent, working on behalf of the airline, stated that she had to follow FAA (Federal Aviation Authority) rules and only allow two bags on board even though the computer bag and pocket book were small. Unfortunately, when asked to “consolidate” the three bags into two, we had a problem. No bag really fit into any of the other bags. The agent wouldn’t “gate check” any of the bags so that we could pick it up when exiting the plane and running off to our next flight. Further, our discussion with the gate agent failed to alleviate our concern that, if checked to its “final destination,” we wouldn’t see a checked piece of luggage any time soon given the shortness of time for our connection.

The solution that followed satisfied no one. Over the next 10 minutes, embarking passengers stepped around the contents of the three bags which littered the entrance to the Jetway. At first, the gate agents ignored the situation, but as tempers flared due to the obstruction of foot traffic, an agent “helped” by aggressively stuffing the computer bag into the overnight bag. A busted zipper later, the bulging overnight bag limped down the Jetway led by a very unhappy customer.

Does this scenario prove airline excellence because the agents showed how well they can comply with government rules? Hardly! Most folks would conclude that this messy scenario wasn’t necessary. In complex situations, the empowerment of professionals to act judiciously given a set of circumstances leads to excellence. The above scenario required the gate agents to apply context while making an overall effort to comply with government regulations. Unfortunately an excellent result didn’t happen in this case.

Similarly, we face the issue of context and judicious interpretation every day in medicine. As a common example, computerized medical records, a well-intended effort to characterize complex information, often fail to convey the true story of a patient or the nuances that make each of us unique. Summarized, bullet point information can easily miss the point. The great composer Mozart famously observed that musical excellence doesn’t lie in the notes but actually in the space and timing in between the sounds. Medical excellence involves a similar concept. Health care providers must read “in between the lines” and understand and respond both to what is and isn’t stated.

What this concept means to the average patient depends on the circumstances. For example, some people with neck pain may need consideration for a heart condition (angina) whereas others should check in immediately for an MRI of the spine and others should book a massage. Distinguishing the underlying cause of the neck pain relies on both a description of the nature of the symptom and on understanding the quiescent pauses of relief between episodes of pain. Excellent clinicians make this distinction by asking the right questions. Excellence during the medical evaluations of headaches, arthritis, and memory problems, among other things, also require this same commitment to careful questioning.

Clinical research promotes excellence by demanding great attention to detail.  During research programs, physician investigators and their staff members must extensively analyze many aspects of our patients’ health.  This thorough analysis usually exceeds that which occurs at the time of general physician visits, a setting during which time pressed clinicians must limit their focus and move on to the next patient. Research also requires the deployment of state of the art technology. The combination of technology and attention to detail of symptoms, signs and lab values leads to an experience which most patients highly value and describe as a demonstration of medical excellence.

In sum, medical excellence involves more than compliance or automatically matching a disease with a drug. Medical excellence is a philosophy of understanding the needs of a patient and putting those needs in context through the development of an individual treatment plan. Clinical research promotes medical excellence by demanding a culture of detail and caring.


superhero-vs-guinea-pig.jpg

Let’s not dance around the issue: for many years now, news sources like CBS, CNN, The Atlantic, and The New Yorker have called research volunteers guinea pigs.  You’ve probably said it yourself. I’m here today to tell you why we need to call research volunteers by another name: Heroes.

The term “guinea pig” is condescending to both volunteers and researchers. For volunteers, it takes away the enormity of their contribution by sounding like they have no choice in the matter. If you have ever taken a prescription medicine for any reason, even an antibiotic; someone has chosen to volunteer to make sure the medicine is safe and works. If medicines down the road are to work better, we need volunteers to keep agreeing to test them.

Calling subjects “guinea pigs” also disdains the research coordinators and doctors that supervise drugs trials. Before any volunteer is admitted into a trial, coordinators fully explain what the trial entails, making sure to answer any questions or concerns of the volunteer. If the volunteer agrees, they go through a screening process to make sure they are a good fit for the trial and that the trial is safe for them. During the trial, the volunteer tells the coordinator or doctor about any medical events, including colds, broken toes, or headaches. This is also for safety, and if anything happens, the volunteer is free to stop the study or change their mind about participating. Throughout the study, the volunteer’s health is closely monitored; patient safety is always first. If a volunteer decides they no longer want to be in a clinical trial, they can withdraw from the trial at any time and will not be coerced to stay.

Before any medicine hits the market it is tested for years, with data constantly being reviewed in between trials. New medicines will go through 3 – 4 clinical trials over many years, with safety and effectiveness being the top concerns.

So, why are volunteers not guinea pigs? Guinea pigs (or any animal for that matter) don’t willingly sign up to be a part of future healthcare that could save lives. Guinea pigs are cute, fat, fuzzy, and they eat their own poop (Coprophagy). But, they do not willingly agree to be part of a trial that could save lives down the road.

So I urge you, quit using the term guinea pig for volunteers, use the term hero instead! We can’t cure diseases without heroes.

If you have volunteered for a clinical trial before, YOU ARE A HERO! If you have never participated, become a research HERO today!

 


Research-Virgin.jpg

Recently, I had my first experience as a clinical research volunteer. Going in, I wasn’t quite sure what to expect, but it was better than I thought!

I have Multiple Sclerosis. I also have asthma, arthritis, hypothyroidism, high blood pressure, and migraines. I live with chronic pain, I’ve had multiple surgeries, and the list goes on. With all these illnesses and conditions I need prescription medications to function on a daily basis.

I’m your average Google symptoms and side effects checker. I think it’s very important since I’m on over 10 daily medications to treat my health issues. I see multiple specialists; and I can’t expect them to research and remember all the ways those medicines interact with the others I’m already on. So I try to be smart about it.

Being a research volunteer has some bad stigmas attached to it. Some people think you might grow a second head or something! I’m here to tell you, don’t believe those outlandish tales! Without volunteers like me, the drugs I’m taking that stop horrible leg cramps or make my migraines back off- wouldn’t have made it to the pharmacy shelves.

When a friend of mine mentioned that her daughter works at Jacksonville Center for Clinical Research, for some reason that statement humanized the whole idea of prescription medications for me.

So I googled them and found they had SO many opportunities for many of the medical problems I currently have. I filled out an online form to be contacted, and a bubbly, friendly lady called me. I wasn’t even sure what to say but she dove right in talking about the different issues I mentioned on the form. She gave me an idea of what they were looking for in the studies, and I answered her questions. It was easy. In no time she had singled out a study I might be perfect for and set up an appointment. We talked through most of it over the telephone and she had it all together when I arrived. It turned out I WAS the perfect fit. It was a study that only required me to come to 3 appointments over a 6 week period and paid me $400. Wow! Did that extra cash come in handy! While I was there everyone treated me like an old friend.

I am doing my part to help put good drugs on the shelves for myself and millions of other people.

Now I know what it’s like to be a hero.

Tracy


Encore logo

As a proven clinical research organization, we take every precaution to assure the safety of and maximize the value for our research volunteers. Qualified doctors, nurses and study coordinators on staff provide support and care throughout the research trial. Participation is always voluntary. We appreciate the time and effort that research volunteers bring to this important process.

Copyright 2020 ENCORE Research Group