The Next Big Thing in Heart Health
Research study of new cholesterol medication being done in Rochester
ROCHESTER, N.Y. – Will PCSK9 inhibitors finally reach FDA approval? Will this be a breakthrough cholesterol lowering medication? This is what Rochester Clinical Research is hoping to find out – with help from the community.
This new study for patients with high cholesterol will be testing the most important new class of drugs in cardiology since statin medications. Cardiovascular disease due to atherosclerosis (CVD) is currently the leading cause of death worldwide.
The aim of this trial is to ultimately determine if the investigational medication helps the body remove more LDL cholesterol (bad cholesterol), which in turn may lower blood LDL levels. The investigational medication requires an injection just beneath the skin (subcutaneous injection) every 2-4 weeks.
“They are going to be easy to take auto-injectors the patients can do at home,” said Dr. Matthew Davis, a principal investigator for the study. “PCSK9 inhibitors are anticipated to be the next blockbuster medication for people with high cholesterol.”
Rochester Clinical Research is currently seeking volunteers that have had or currently have high cholesterol to join this trial. Participants will be provided with the study drug, study-related care, and compensation for their time and travel. Those interested who would like more information are encouraged to call Rochester Clinical Research at 585-288-0890. Or text “INFO” to 87888
About Rochester Clinical Research:
Rochester Clinical Research was founded in 1994 with the objective of providing the Greater Rochester area with access to a premier clinical research facility. The goal of the organization is to advance new medical treatments and improve the quality of life for individuals everywhere. Rochester Clinical Research puts great pride in the relationships it has with its sponsors, volunteers, and staff. The organization strives toward advancing new medicines and catching up with diseases before they become a problem.
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Getting Over the Fear of a Placebo
So what is this thing called a placebo? Why is it used? Why is it necessary? Most of all, why shouldn’t I be worried about it?
One of the leading reasons why individuals turn down clinical trials is due to the fear of receiving something called a placebo. We can understand that. No one wants to volunteer their time pursuing an investigational treatment just to find out they didn’t receive the investigational treatment. We’re here to tell you that just because a ‘placebo’ is incorporated into a research trial does not mean your volunteering is not worthwhile.
What is a placebo?
If you are unaware, a placebo is a replication of a treatment that does not contain the active ingredient. A placebo is harmless and those that receive a placebo as part of a clinical trial are typically placed in a ‘control group’. Those that receive the investigational treatment are placed in a group known as the ‘active group’. Before a placebo is used in any research study, it is reviewed and approved by an ethical review board to ensure its use is moral and constructive.
Why is a placebo used?
Using a placebo is one of the most efficient ways to calculate the effectiveness of a new treatment. By pairing the data of those that received a treatment with those that received a placebo, researchers can make a definitive calculation as to whether a drug was effective through comparison. Placebos are a major factor in being able to measure how useful an investigative treatment was during the study.
Will I know if a placebo is part of my study?
You will always be informed if a placebo is involved in a study that you have expressed interest in. And placebos are only incorporated into trials where the condition being treated is non-life threatening and the placebo is deemed safe for use. Worth noting is that if you do in fact receive a placebo as part of trial, your condition will not worsen from study participation. A placebo is purposelessly harmless and you may in fact still benefit through the medical attention you receive as part of the study.
Why shouldn’t I be worried about receiving a placebo?
There are many reasons why you should relax when it comes to potentially receiving a placebo. The most important reason being that we treat every patient the same way. Meaning placebo or not, your safety and care is our top priority. We make sure every volunteer is safe and secure throughout every trial. And to be honest, in almost every trial involving a placebo, we are even unaware of who receives a placebo and who does not which eliminates any bit of bias that could arise.
As previously mentioned, the most important reason why research studies integrate a placebo is due to its effectiveness in measuring results. The goal of clinical research is to make strides toward improving the condition of life for those in need. Our goal is overseeing this research in the safest environment possible. Placebos allow us to achieve both of these goals by enhancing the capabilities of a research study without increasing any sort of risk. You would be amazed at the list of today’s common drugs that were approved through use of a placebo trial.
It is important to reaffirm that the contribution of those that receive a placebo as part of a trial is just as meaningful as anyone else’s. You volunteered, you provided valuable data, and you have made a significant difference. You will still be rewarded for your time and travel.
The name of the game is advancing medicine and changing lives and every second you volunteer is part of a continued effort in turning goals into reality. If that is not reason enough for you to be a fan of them, give us a call to ask us any lingering questions you have.
4 Hard Questions to Ask Yourself Before Joining a Clinical Trial
As you move through the enrollment process, you will undoubtedly learn more about the way things work. You will be heavily educated on what you’re getting yourself into.
But on a high level, what are the major questions you should ask yourself before taking the first step of calling to start the enrollment process? Consider the following four questions:
- What exactly am I getting out of participation?
This is perhaps the most important question for anyone who has never experienced a clinical study. More often than not, volunteers will return for another trial. In fact, CISCRP reports that 95% of volunteers would consider participating in another trial.
Back to what you will actually get out of participation. While there are many benefits to participation, the most popular reasons include learning more about your condition, access to new medication or healthcare, and compensation for your time and travel. These are real takeaways from participation.
We think the most significant takeaway is the internal feeling that you contributed to something that will help someone beyond yourself.
- How am I going to be protected?
This is an essential question for anyone considering participation.
As every hospital, doctor’s office and health clinic is governed by ethical and legal codes, the same guidelines apply to clinical research studies. In addition, our organization is federally regulated to make sure we protect our patients to the fullest. All study plans and designs are carefully controlled and overseen by government agencies, institutional review boards and our staff.
Your protection is our job and we do not allow patients to go uninformed. We keep everyone in the know at all times, protecting your well-being and privacy at every turn.
- Why are you having this study in the first place?
Clinical trials are conducted to uncover answers to specific questions. In doing so, new medications, vaccines, devices and technologies can move toward FDA approval. FDA approval means someone somewhere who needs this new treatment can now access it.
There is a specific reason for every trial. And every trial aims at advancing treatment and the quality of life for someone with a condition or illness. Clinical studies are never purposeless and without them we’d have no progress in medication and treatment.
- What is going to happen to me during the trial?
Deep breath! We are not about to send you into some dangerous and confusing situation which we hope you make it through. We take it one step at a time, tell you what you can expect and what the trial is designed to achieve. Every trial is different, but one thing remains the same: your contribution and volunteering keeps alive the hopes and dreams of those living with potentially treatable conditions and illnesses.
There you have it: four hard questions you want the answer to before joining a trial. Do you have another question on your mind that you need an answer to? Call us today.
The Big 5 Benefits of Trial Participation
Sometimes it helps to start at the beginning. Since we’ve spoken with so many new people over the last couple of months, it only makes sense that we revisit the most common benefits of participating in a clinical research study.
You may have heard them before, and if you’ve joined us for a study, you have already realized one or more of the following. Without further ado, here are the ‘Big 5’ benefits to participating in a clinical research study.
Access to new medication
Nowhere else are you able to access the most cutting-edge and innovative medications than you are as part of a clinical study. This means those who have not had success with other treatments can try something new. This means that those who are out of options, or were without any to begin with, have an opportunity for treatment. This is an exciting benefit for many participants.
Access to study-related medical care
We know a lot of people live day-to-day without healthcare or insurance. And sometimes, those that do not have coverage suffer from a costly illness or condition. We do not discriminate. We are in the business of helping people live better lives. Therefore, we offer the necessary study-related medical care attention for free with participation – no insurance required.
Compensation for your time and travel
Did you know that every clinical trial offers participants a monetary award for their time and travel? We don’t like the idea of taking up your time without providing you something in return. So we happily offer you reimbursement like any other job would. Your time is worth something.
Advance medicine for the next generation
Have the urge to contribute to medical science? Like the idea of someone benefiting from your volunteering? Clinical research is one of the most unique ways to volunteer and help others. Your willingness to take part in advancing medicine helps others tenfold. Every volunteer pushes medicine in the right direction.
Learning more about your condition and health
Perhaps the most underestimated benefit of joining a study is discovering more about your own condition and levels of health. Chances are your primary care physician or specialist have talked with you at length about your status, your conditions, and what it will take to stay or get healthy. But a clinical trial can provide an opportunity to learn more about yourself and your condition through the unique patient education provided by our medical staff.
There you have it. The Big 5 benefits of trial participation.
You’re invited to realize one of these benefits today! What are you waiting for?
Our Take on the Vaccination Debate
We are not afraid to state our beliefs on vaccines and the vaccine ‘debate’ currently taking place around the country.
We are extreme proponents of vaccines.
We have seen firsthand how effective and essential vaccines are. And with the resurgence of a Measles virus that was nearly eradicated, vaccines are now as important as ever.
Yes, we are in the vaccine research business. But we base our convictions off of facts and not biases. Never mind the opt-in vs. opt-out conversation. What matters are the actual numbers and our drive to enable everyone to live a more fulfilling and healthy life. Consider the following:
Immunization prevents between 2-3 million deaths every year worldwide. (World Health Organization)
Can you argue with that? Consider how many more lives could be saved if everyone had access to vaccines. We are so fortunate to have access to vaccines in this country. We advise you not to take that for granted.
Most childhood vaccines produce immunity about 90% to 100% of the time. (Vaccines.gov)
The upheaval surrounding vaccines started with parents who chose not to vaccinate their children, and in turn, created an environment where a preventable virus took off. The science on the effectiveness of childhood vaccines is clear. Why risk it?
An average of 50,000 American adults die from vaccine-preventable disease every year. (Centers for Disease Control and Prevention)
Why would anyone put themselves in jeopardy of contracting a preventable virus like the flu, pneumonia, or hepatitis B? We offer these vaccines for free every year. Get yourself vaccinated. Stay safe and stay alive!
Before vaccines, the only way to become immune to a disease was to contract it, and with luck, hope to survive it. (National Institute of Allergy and Infectious Diseases)
This statement stands up to how effective vaccines have been in our lifetimes. Prior to breakthroughs in vaccine science, immunity was established through high risk measures without concrete results. Consider how crucial vaccines are today.
If vaccines weren’t used, just a few infectious cases could quickly turn into tens or hundreds of thousands. (Centers for Disease Control and Prevention)
And we’ve seen this on the news. This is what is happening and thankfully on a smaller scale. You’re walking on thin ice when you choose not to vaccinate yourself or your children. That risk can quickly explode into unanticipated harm and sickness.
Scientific studies continue to show now tie between vaccines and autism. (Centers for Disease Control and Prevention)
This is perhaps the most important fact in the debate at this time. It is also the best ‘argument’ that the opposition to vaccines has, and it has been proven to be untrue by more than one credible scientific body.
You now know where we stand on this issue and we cannot find one reason why anyone would argue against our reasoning. Vaccines are beneficial to everyone, old and young. Vaccinate yourself for your own well-being and the well-being of anyone you love or care about.
Several hundred volunteers participated in vaccine studies at RCR in 2014. And if the facts above are any indication of how effective vaccines have been to date, the research our volunteers have contributed to will strengthen both the argument for and effectiveness of vaccines in the coming years.
Clinical Research Misconceptions
It seems that far too often we are correcting misconceptions on clinical research volunteering. We know there is a lot of information out there. We also know a lot of it is misleading and untrue. The good news is we are always happy to educate and correct inquiring volunteers about the myths surrounding clinical research volunteering. Let’s take a look at some of the most common concerns we hear.
If I don’t volunteer, someone else like me will.
Every person is different. That means every volunteer can offer something unique to research that another person cannot. An overwhelming majority of people say they would consider getting involved in a clinical research study if asked, but only 10% of those people eligible to volunteer in a clinical trial actually do so in the United States. New volunteers are always needed in order to keep advancing new medicines.
I’m healthy. I thought clinical research was only for people with certain health conditions.
Healthy individuals without a preexisting condition are some of our most important volunteers. These volunteers can make just as meaningful contributions to medical research as anyone else. Healthy individuals for blood samples are almost always wanted. And many of our vaccine trials are geared toward this same group. If you are healthy without a preexisting condition, we likely have a study that works for you.
I won’t be able to leave a study once it begins.
While we encourage you to see the trial through, at any time you may walk away if you feel uncomfortable. Before doing so, we encourage you to bring up your concerns. Chances are we can accommodate or at least answer your worries. Our job is to make your study experience in a study a fulfilling one.
Clinical research studies are too dangerous.
Every clinical research study presents some level of benefit and risk. But it’s important to note that medical research studies are carefully conducted with the highest level of oversight. The ethical and legal codes that govern medical practices nationwide also apply to all clinical trials. Most of the clinical studies we conduct are federally regulated which means mandated safety and precautionary measures are put in place to keep all volunteers safe and informed.
I will be disqualified because I have a unique health condition.
The real reason why you might be disqualified is safety, not because of a unique condition. The chances are that your situation will be a perfect match for a study either now or in the future. But if you never inquire with us, you will never know if you may in fact qualify. If you are actually disqualified due to a condition you have, it is only for reasons of safety – don’t take it personally! We are here to consult you to a trial that best fits you, your condition and your interests.
I’m too old/young to join a study.
Every clinical research study has a different requirement for age. And because of that, we have welcomed volunteers of all ages over the course of our history. With our current studies changing frequently, at any time Rochester Clinical Research is seeking volunteers from the age of 6 months old to 110 years young. Let it be known that there is no age limit to volunteering with us.
I need health insurance to partake in a study. I will not receive any medical attention during a study.
You do not need to have health insurance to participate — plain and simple. Federal law and our own ethics demand that we make certain that every volunteer receives proper medical attention throughout the course of the study. We keep close tabs on every patient we treat, and your safety and care is our top priority.
Have you heard something that we didn’t cover here? Please contact us. We are always here to provide you with the information you need.
Don’t Downplay Your Pain
In recent months, many of our studies have involved researching treatments for pain in joints and muscles. And in talking with potential volunteers for these studies, our recruitment team has noticed an unfortunate but natural habit of some of our candidates.
Our pain treatment studies are great opportunities for those dealing with pain to get early access to new and investigational treatments for their condition. However, many candidates that could potentially be a fit for these studies are continuing to eliminate themselves before reaching an initial visit. In order to qualify for many of these studies, it may be required that you experience a certain level of pain in your day-to-day life. So when we speak with you, it is important that you consider the realization of you pain levels.
When our recruiters are working through the process of informing you about joining a pain treatment study, one of the most important questions we ask is ‘how severe is your pain?’ And it’s your response to this question that may determine if you’re a potential fit for a study.
For example, those of you with knee issues often experience some level of pain around the clock. Sometimes it hurts a lot and sometimes it’s ‘not so bad.’ Either way, you always have some discomfort, and this discomfort is pain. But because some level of pain is always there, you may have a naturally high tolerance for it. And when we are speaking with you, you naturally downplay the severity of your pain.
Remember, just because you manage to live with chronic pain every day does not make your pain any less severe! Ask yourself, ‘how might my pain compare to someone without any pain?’ A good day for you might be considered unbearable to someone else. If walking up the stairs creates serious discomfort in your knee, recall the time when it didn’t hurt at all and make a comparison!
It is of course constructive to live life with a positive attitude despite this discomfort. However, in this situation, objectively acknowledging your pain may lead to opportunities for relief. This does not make you a complainer, just an analyzer of your symptoms.
We are asking that you don’t downplay your pain! Be objective and honest when discussing your pain levels with us. We are in this together to advance the quality of life for both you and those dealing with your same condition.
5 Steps to Joining a Research Study
One of the most common questions we receive from potentials volunteers is, ‘What does it take to join a research study?’ If you have been a part of a study before, then you know how it works. Still, it’s always good to refresh yourself on the procedure. If you haven’t joined us for a research study before, you’ve come to the right article. Here are the 5 steps to joining a research study:
Step 1: Identify a study of interest
There are many ways you can find out about a study at RCR whether it be radio, television, social media or the internet. The best place to locate our currently enrolling studies is www.rcrclinical.com. By glancing through our current studies, you can see if something might be a fit for you. If you do not see a study that works for you, give us call or email us at firstname.lastname@example.org and we’ll keep you in the loop when something pops up!
Step 2: See if you qualify
After you have a study in mind, the next step is seeing if you qualify. One way to do this is by visiting the study page on our website. We provide a ‘Check Right Now’ button for you to click and see if you pre-qualify using the entry criteria. By clicking the ‘Check Right Now’ button and answering the questions listed, you will be prompted to ‘Request a Phone Screen.’ As always, if you learn about one of our studies somewhere else than the internet, call us and we can bring you up to speed.
Step 3: Pre-screening
You have found a study of interest and reached out to us about potentially enrolling. At this point, one of our recruitment specialists will now have a phone conversation with you about the study and its requirements. This conversation is a very important step in joining a study as you will be able to ask and learn about every detail of the study. After you pass a pre-screen, you will then visit us in person.
Step 4: Screening visit
Welcome to Rochester Clinical Research! At this initial visit, one of our doctors will discuss your medical status and the benefits and consequences of joining the study. Don’t fear – our biggest goal is keeping you informed and safe. After a screening visit and a review of your medical history, you will be invited to join the research study if you meet the criteria.
Step 5: Enrollment
Congratulations! At this point you will now have enrolled in a research study. By volunteering, you are advancing medicine and improving the quality of life for someone in need.
The Importance of Flu Vaccine Research Studies
Are you aware that the flu vaccine requires revision every fall to ensure it is effective in helping Americans avoid the flu? Without these annual adjustments, the vaccine you receive at your drug store or doctor’s office would not do the job it was meant to do; it would not stop the flu.
Every year, the influenza virus goes through a mutation which renders last season’s flu vaccine not as powerful. This new flu virus is more capable of infecting individuals and outperforming the existing flu vaccine. It is extremely important to match the new vaccine to the new flu virus as the strain deviates each season. The U.S. Centers for Disease Control and Prevention (CDC) reports that during years when the flu vaccine is not well matched to the circulating virus, it’s possible that no benefit from the flu vaccination may be observed. On the contrary, the CDC states that with a proper match between the vaccine and virus, the vaccine can be very effective.
In clinical research testing, volunteers play a vital role in confirming that a new vaccine is indeed efficient. Without research volunteers, there would be no advancement of the vaccine. Without advancement, many more people would suffer through the flu. And considering the flu kills an estimated 36,000 people every year, it is vital to have an efficient flu vaccine every fall.
It is important to note that in researching the vaccine, clinical research sites adhere to strict and legally-binding ethics and moral codes. Mandated safety precautions mean volunteers are overseen to the greatest extent to guarantee well-being. On top of that, the FDA and CDC monitor each and every vaccine being disseminated and tested across the country. It is important to understand that: No, you cannot get the flu from the flu vaccine and yes, you will directly benefit Americans everywhere.
Are you now interested in advancing a new vaccine? Volunteers are needed and right now is the time. Every volunteer creates a step toward preventing illness and potential death. At Rochester Clinical Research, we proudly participate in advancing the flu vaccine every fall. Volunteers who visit us know they are advancing medicine and saving lives.
At Rochester Clinical Research, we now have multiple openings for volunteers interested in helping their family and friends avoid the flu this year. Each volunteer will receive study-related care and medication at no cost and compensation will be provided. Please call Rochester Clinical Research today at 585-288-0890 to find out how you can participate.
“Living with Rheumatoid Arthritis: Third Edition” Available Now
With the third installment of her series on rheumatoid arthritis now in bookstores, Dr. Tammi Shlotzhauer answers a few questions about her new book “Living with Rheumatoid Arthritis: Third Edition.”
Q: Congratulations on the publishing of your new book, “Living with Rheumatoid Arthritis: Third Edition.” What have you added with the updated edition?
A: Thank you! The book has been extensively revised. So much has happened in the past 11 years that very little of the last edition has remained. The new medications for RA are numerous and, of course, that part of the book has been updated significantly. I have tried to describe how the immune system is effected by RA and how the new medications combat those changes. There are several new illustrations that I hope will help clarify this complex area as well. The biggest revisions, however, have occurred in the parts of the book that describe how RA may be triggered in the person with the right genetic predisposition. In discussing those potential triggers, there is much new information on the effects of smoking, obesity, and diet on the development of RA. This is reviewed in detail and has some exciting implications for treatment.
Q: What can readers expect from the new book in terms of takeaways and advice?
A: More than in previous editions, there is much more information on what you can do to control RA with non-pharmaceutical approaches that work together with the new and exciting medications that are now available. Readers will have a thorough understanding on the benefits and limitations of all areas of treatment: exercise, diet, supplements, alternative treatments, and medications. They will also learn about how stress and poor lifestyle choices can actually worsen RA. More importantly, they will read about techniques to reduce these triggers and create a healthier existence. Although there are many remaining questions about the best approach to treating RA, the reader will have an enhanced understanding of the issues at hand. They will be well prepared to understand the choices that they will need to make when managing this condition.
Q: What are your hopes for this new third edition?
A: My hopes are that people will read this book and be as excited as I am about the hope for each of their futures. That future is bright! My hope is that people reading this book will feel much more optimistic and equipped to handle this condition, its obstacles, and the decisions that will be presented to them regarding treatment.
Q: What does the future hold for rheumatoid arthritis patients?
A: I believe that the future is very promising. The new medications available have made it possible to significantly improve the lifestyle of even the most significant cases of RA. New data on the effects of diet are just starting to surface. There are still many questions, but as we learn more about the genetics and triggers of RA, we will be closer to learning how to prevent this condition. Until then, the new information and treatments available now will certainly enhance the wellness of people who are struggling with RA today.
The book is available now in hardcover, paperback, and digital at publishers everywhere, including Amazon.
Why You Should Have a Biometric Screening
Have you heard the term biometric screening before? Now you have, and it might be in your best interest to schedule one of these screenings as soon as possible.
What is a biometric screening?
A biometrics screening is a simple procedure performed by a medical professional at a regulated healthcare organization to calculate someone’s basic health statistics, otherwise known as biometrics. These screenings are quick, painless, and informative — some of the reasons why you should consider scheduling one.
What is measured at a biometric screening?
At each screening, your important biometrics are assessed. A screening typically includes measurement of your:
- Height and weight
- Body mass index
- Glucose level
- Blood pressure
- HDL/LDL and total cholesterol (lipid profile)
- A1c blood sugar (for diabetics)
Why should I have a biometric screening?
- By knowing your biometric numbers, you will be able to assess your current level of well-being. This can help you begin or continue to live a healthy lifestyle.
- Many insurance companies and employers provide an incentive for individuals to undergo a biometric screening. The data received at your visit can be transferred to your provider to potentially arrange for an insurance discount or rebate. Some companies offer up to $300 annually for people to undergo a biometric screening! However, it’s best if you check your insurance plan to be sure.
- Most companies use biometric screening data to guide corporate wellness programs and work environments which can create a better work atmosphere for both you and your employer.
RCR is now offering biometric screenings!
At RCR, each biometric screening is performed by one of our certified medical professionals and normally takes less than 15 minutes. Through a sample blood droplet, your results are available in minutes. You will also be able to discuss these number with a member of our medical staff. And, we are happy to listen to any concerns you might have.
If applicable, a copy of your results will be sent to your doctor. We will also ask you if it is okay to retain a copy for future contact.
What is the cost of a screening?
At Rochester Clinical Research, we happily provide screenings free of charge to everyone. No Co-pay is required and health insurance or employment is not necessary.
How can I schedule a screening?
At any time, we are happy to field questions or concerns on biometric screenings. To inquire about scheduling an appointment please call us at 585-288-0890. Or visit the study page where you can click the ‘Check Right Now’ button to submit your information. What are you waiting for? All you need is 15 free minutes!
To determine if there is an incentive available for you to undergo a screening, we recommend that you contact your employer or insurer. Your insurance provider may have paperwork relating to their Wellness program that you may need to bring to our office.