Center Watch, a worldwide network of clinical trials information, performs clinical trials on an extensive list of medical phenomena and conditions in various phases, including rheumatology, obstetrics and gynecology, endocrinology, hematology, otolaryngology, neonatology and pediatrics to maxillofacial surgery. Center Watch boasts a large patient database, numerous support groups and blogs. The goal of Center Watch is to explore and identify medical disorders and conditions in order to discover treatments and therapies to improve affected people’s quality of life. This prominent research center has a venerated sleep disorders research branch, The Sleep Disorders Center of Alabama, located in Birmingham, Alabama.

The Sleep Disorders Center of Alabama is a state-of-the-art freestanding sleep center in eastern Birmingham offering six PSG (sleep) rooms. In 2005, the center was certified for its sixth 5 year accreditation from the American Academy of Sleep Medicine. About 1,700 clinical studies are performed at the center each year and about 140 new patients are seen there each month. The sleep center is conveniently located seven miles from the Birmingham International Airport. The center’s large patient database is responsible for most of the center’s patient recruitment.

Each of the sleep center’s six bed-equipped suites has a private shower, large high definition LCD televisions with cable and digital recording devices that can be converted to European Data Format for viewing at any central scoring site. Continuous positive airway pressure (CPAP)/bilevel titration and full polysomnograms for sleep disordered breathing can be performed in any of the six rooms. Each room also offers multiple sleep latency testing (MSLT) for extreme daytime somnolence such as idiopathic hypersomnolence or narcolepsy. Tests for atypical behaviors that occur during sleep such as rapid eye movement (REM) behavior disorder are also performed at the center. Phase II through IV trials are performed at the sleep center in the following remedial areas: cataplexy, fibromyalgia, obstructive sleep apnea, restless leg syndrome, insomnia, chronic obstructive pulmonary disease, narcolepsy, periodic limb movement syndrome and shift work sleep disorder.

Center Watch offers a number of support groups for those with fibromyalgia, spinal cord injuries, Lyme disease, pediatric heart disease, lung cancer, intestinal diseases and disorders and polycystic ovarian syndrome (PCOS). Center Watch has performed over 80,000 clinical trials spanning hundreds of diseases and phases including 5,296 epilepsy studies, 538 studies on ulcerative colitis, 1,195 studies on atherosclerosis, 423 studies on kidney transplants and 3,944 studies on osteoarthritis. The center’s research staff members are dedicated to achieving efficiency in researching, patient contact, recruitment, patient care and pharmacological testing. Center Watch’s online database generates over one million new visitors each year, making it a nationally well known and respected research center.

A little while back I started a segment on my blog called “RA Friends”, where I encouraged others with rheumatoid arthritis to open up about their life with RA by answering some commonly wondered upon questions. At least questions that I felt were important for outreach to the newly diagnosed or the newly searching for connections. I currently am working on rebooting that segment, and I thought I’d start again by answering some questions about my own experience with RA. Some of those questions that people might wonder about if they haven’t read much about me or known me very long, and some questions that I‘ve received by email from readers. So here it goes . . .

How long have you been diagnosed with RA and what treatments have you been on?

I was diagnosed with Juvenile Rheumatoid Arthritis 13 years ago and have since been on my fair share of arthritis drugs. I was young so my treatment first started with simple steroid injections at the site of the swelling, sometimes associated with draining the fluid from the joint. That was a fun time. After months and months of those exciting needles, my then rheumatologist turned to weekly injections of Methotrexate, a drug that I am currently on in pill form, but that took me a while to find the right dosage. I had some unfriendly reactions to it at first, but eventually we came to find a dose that worked and kept me feeling well.

Later we added twice weekly Enbrel injections. As a teenager I was giving myself three shots a week on Tuesdays and Thursdays. At this time I was such a baby about needles still that we had to enlist the help of family friends who happened to be nurses and neighbors that were doctors. Once I even had to get my older brother with Diabetes to give me a shot. What a wimp.

Eventually I needed more, and we turned to Remicade. I was getting an IV once every four weeks for a few years, which carried into my college years. Later on my new rheumatologist would decrease how often I came in for treatment, but I was on Remicade for a total of 5 years.

I chose to go off Remicade and back on Enbrel, though at a once-a-week dose. It’s currently a love-hate relationship. I love how it works to give me no swelling and little joint pain . . . But I hate those damned shots.

A little lighter now, what hobbies do you have and how has RA affected them?

Growing up I didn’t have a lot of very “active” hobbies, I think mostly because I didn’t think I could do much physically with my RA. When I met my husband, a very active person himself, I pushed myself outside of my comfort zone and found that I am able to enjoy quite a few very active hobbies. I love skiing. I’m not a great skier, but I love putting some music on an iPod (oddly, the only time I‘m a hip-hop fan is while skiing), cruising on some “blue” runs and carrying on conversation while skiing side-by-side with friends. I found that keeping up with exercise and building my leg muscles helps with keeping my joints happy while skiing.

A couple years ago I started golfing by taking a ladies golfing class through a local driving range. Again, I’m not the best golfer, but it’s a fun thing to do, and also easy on my joints. Recently I started paddle-boarding, which I LOVE. It would be nice to take up surfing while living in Hawaii, but I like the calmness of paddle-boarding for now.

On the less-active side, I love to cook and bake. I’ve been teaching myself how to cook over the last couple of years, and trying to create new Paleo baked-goods recipes is both challenging and fun! I’m also an avid movie and TV watcher. I like to place my laziness and watching shows in the category of hobbies.

How do your friends and family deal with your arthritis troubles?

Most of my family members are very understanding about my health, and probably a little too inquisitive, but it’s a good thing. My parents went through the whole diagnosis and beginning of my life with arthritis while I was growing up, so they take my ups and downs very personally. If I ever need to talk about my pain I go to them, but I also like to keep them from the hurt of knowing my worst moments (if that makes sense).

My husband is the person I am the closest to, and he tries his best to understand what I’m going through, but is aware that he won’t ever really be able to understand the pain. He is extremely supportive, though, and will always accompany me to any doctor appointments I have, which I find incredibly helpful! Love that man!

Only a few of my closest friends know much about my arthritis. I pick and choose who to tell, and those that know understand that I sometimes have limitations . . . For the most part!

How do you stay positive on your worst days?

We’ve all had our bad RA days. Days where we can’t get out of bed or off the couch. When we’re embarrassed to be seen with swollen joints. I try to relax as much as I can on those days and treat myself to things I might not normally do very often, like getting a pedicure or splurging on some online shopping. But even on days when there isn’t obvious swelling, things can still be hard on me. I try to preoccupy myself with things I love, like being with my family, beautifying my little home and playing with my pets. Often just taking some time to talk it out with my husband and then laugh about things makes me feel so much better.

We all have our tough days. Sometimes I’ll give myself 30 minutes to stress or feel bad about things, and then after the time is up I gotta move on and get working toward making things better.

More questions and answers to come!

There are a lot of people out there who write about their life with arthritis. You can find a number of different blogs by normal, wonderful people who talk about their struggles with RA. How they cope. How they try to help the people around them understand their pain. Often you will find people who have children with juvenile rheumatoid arthritis and they work hard to help maintain a happy childhood for their kids with pain they can hardly understand. It’s all out there, and it’s all helpful.

But no one really talks about what I spent a majority of my life with RA doing . . . pretending I didn’t have it.

When I was diagnosed I was 12 years old, in middle school, going through the tumultuous, chaotic world of an adolescent. The last thing I wanted was to have to deal with something that would make me more of an outsider, different from all my friends, less “cool”.

So I went on as if nothing was wrong. I’m not sure how many of my friends at the time knew what I had and what I was going through. I didn’t get into the details much, because at the time I really didn’t know much myself. And I really could care less.

This attitude continued on through high school, and it didn’t help that boys started to become a bigger part of my life. Let me tell you, nothing makes a teenage girl sexier than swollen knees and little to no energy. I had 2-3 girl friends that I’m pretty sure I told. It seems so long ago, and I cared so little about it that it’s hard to remember.

I got really good at covering it up. I might miss a few days of school in order to see my rheumatologist, have a minor arthroscopic surgery, or I just couldn’t get myself moving much that day. But those were things that were kept hidden. You wouldn’t know it from looking at me that I had more of a burden than your average teenager. And I lived that way for my entire adolescence.

Even through college I rarely told anyone. I had to tell a few professors about it, mainly because I was having Remicade infusions throughout college and I needed to be excused from a day or two off every month. That was a weird thing for me to get used to – being open about my arthritis to people who actually had a need to know. I was a theatre major and took movement and dance classes often, so I had to keep those teachers up to date on my body, but there was no need to share the details of these conversations with any of my classmates.

It wasn’t until years later that I started writing about my life and opening up about my arthritis. I’m pretty sure it surprised a number of people who have known me growing up.

In some ways it’s therapeutic to be able to talk openly about my health, but I still find myself keeping quiet about it unless somehow the topic comes up. There is no real need for me to gab about my achey joints to my neighbors, or bring up how swollen I am when we’re out at dinner with friends. I prefer people to see me as I am, not labeled as the poor girl with arthritis . . . (and why does she have arthritis if she’s in her 20s? weird!)

Like I said, you can search the internet for a number of people teaching you how to explain to others what life is like for you. I think it’s important to be open with the ones you love, and to not keep your troubles inside as it can prove to be unhealthy to hold those things in. But you should also be able to live how you want to live. If that means keeping the details of your health to yourself, so be it.

And hopefully those parents out there with kids who have arthritis read this and understand – when you are growing up and dealing with RA, there’s nothing you want more than for it to go away. Some of us cope by keeping it a secret and that’s fine.

Eventually we all learn to embrace it and understand it . . . but for now, let’s fool everyone.

Over the holidays I got a lot of questions about my diet, because I generally have quite a few restrictions that I follow closely on a daily basis. Although during Thanksgiving all the rules went out the window when delicious pies and cakes were present. As I dug my fork into pumpkin cake with cream cheese frosting I explained my paleo diet, why I chose to follow it, and how I came to learn my own allergies and reactions to specific foods: through an elimination diet.

When I first did that pesky elimination diet I was met with so much aggressive questioning I almost didn’t want to do it. The point of doing an elimination diet is it’s a way to find out what foods you might possibly have allergies to. Allergies for me meaning what foods might be associated with my joint pain. Though there are certain aspects of the meal plan that are questionable (the fact that throughout you mainly eat beans and rice – foods that could cause negative reactions themselves) I found it extremely effective.

I’m not gonna lie, it was ridiculously hard to do. There is an easier way to go about finding food issues – going to a special doctor who can run tests and find reactions through that fancy thing called modern technology – but this is a cheaper way. It takes a long time but through the process I found serious results: I have a definite correlation between joint pain and dairy products.

The sad thing is, all the best foods are made with dairy. What is wine without good cheese and bread? How can I enjoy my morning coffee without a splash of delicious, sweet vanilla creamer? How can I beat the heat without my favorite ice cream straight out of the carton?

All the best desserts are made with dairy. Sad face.

With the knowledge gained from doing this elimination I now look at food differently. I’m more aware of what I’m putting into my body and how it’s going to affect me. I don’t completely deprive myself of dairy, but now I know that if I finish this cake with frosting my knees aren’t going to be happy for the next few days. I know to be prepared. It’s another tool I can use to handle living with rheumatoid arthritis.

Through the next few posts I’ll take you through each stage of the elimination – or how I went through it anyway. There are a ton of other resources out there on how to do this. I recommend checking out what other people have to say about it ahead of time. What I write is based on my own experience and how I altered the already set stages to fit my lifestyle and make it easier for me. I am in no way a doctor or a nutritionist or anything fancy – just a girl with RA trying to find triggers and sharing my journey along the way. Booya!

Clinical research has provided us with medical breakthroughs and new medications which have vastly improved the quality of life for many people. In our not too distant future, diseases that plague the lives of many will be a thing of the past. Participating in a clinical study can be a great option and not just for people who have a disease or condition. There are a broad range of clinical trials being conducted in Birmingham, AL at the Achieve Clinical Research facility.

Have you or a family member been diagnosed with a serious illness? If yes, then participating in a clinical trial in Birmingham can provide you with access to state of the art treatment that you could not find anywhere else. The range of different conditions that Achieve Clinical Research focuses on is truly immense. There are upcoming clinical trials for gout, chronic pain, high blood pressure (hypertension), influenza, psoriasis, migraine headaches, and shingles just to name a few. Their highly qualified staff has expertise in a very diverse range of medical fields, so they can certainly handle a lot.

The Achieve staff assigns a team of clinical research coordinators assigned to every trial they conduct. Their physicians are all board certified and they act as the primary investigators with oversight on all trials. Achieve employs a laboratory staff, their own recruiting call center, a receptionist, and pharmacist. Achieve Clinical Research’s goal is to conduct thorough phase II-IV clinical trials in Birmingham. To do this they need dedicated staff, which can handle a large number of clinical trial participants effectively. They are very well trained and committed to bringing people the best medical care possible.

Achieve Clinical Research is primarily focused on conducting phase II-IV clinical research trials. Their sister site focuses on phase I clinical trials in Orlando, FL , and this cooperative system benefits both sites very well. Their research facility is state of the art and fully equipped to handle the wide array of clinical research trials that are being conducted here. They have the latest medical equipment on hand, and their staff is fully trained in utilizing these tools effectively. If that isn’t impressive enough, the facility’s location could not be better. Located right in the heart of Birmingham’s medical district, there are fully functioning hospitals nearby for any outpatient procedures.

One of the most important aspects of running a successful clinical research facility is having the ability to effectively recruit the necessary numbers of people for your clinical research studies. Fortunately, Achieve Clinical Research maintains a great recruiting call center team, which is fully capable of enrolling clinical trial volunteers on a continual basis. Potential volunteers include not only special patient populations but also healthy volunteers. Birmingham is home to more than 20 colleges and universities. This provides with a hugely diverse potential patient population which is continually growing. With its dedicated and well-trained staff, Achieve Clinical Research will always be able to meet its recruitment goals and help to continue furthering modern medicine.

The cells of the human body rely on glucose, an important form of sugar, for their functioning. The body gets its needed glucose from the glucose made in the liver and muscles as well as from the foods we eat. Insulin, a chemical produced in the pancreas, is required for glucose to be absorbed by the cells. If an insufficient amount of insulin is produced, or if the insulin is not functioning suitably, the glucose won’t be taken as needed by the cells, and it will build up in the blood stream. This build-up causes high blood sugar, which leads to pre-diabetes or Type I or Type II diabetes. People of all ages and with all sorts of dietary habits can be affected by diabetes.

Avail Clinical Research is currently conducting a wide array of clinical studies targeted towards Type I & Type II Diabetes. You may be eligible to participate in one of our diabetes clinical trials near Birmingham and contribute to the development and approval of a new drug or treatment. As a participant, there is no cost to you at any point during the study and health insurance is not required.

Browse our clinical trials being conducted now to find the study best suited for you: Outpatient diabetes study currently enrolling patients ages 18-75.

Not all diabetes patients experience any symptoms before their diagnoses. The test for diabetes involves a simple blood test to assess glucose levels, and the test will detect diabetes whether or not a patient experiences symptoms. If a person experiences any of the following symptoms, he should consult his healthcare professional: severe thirst, frequent urination, severe hunger, exhaustion, unintentional weight loss, dry or itchy skin, slowly healing sores, tingling or numbness in the feet and/or blurred vision.

When the immune system attacks and destroys the beta cells of the pancreas, the beta cells stop producing insulin. This leads to Type I diabetes. Type I diabetes (formerly known as juvenile diabetes or insulin-dependent diabetes) is usually diagnosed in children, teenagers and young adults.

Upon insulin resistance, a disorder in which fat, muscle and liver cells are not properly using insulin, Type II diabetes (formerly known as adult-onset diabetes or noninsulin-dependent diabetes) results. The pancreas is forced to produce enough insulin to keep up with the increased insulin demand. However, over time the pancreas becomes incapable of secreting enough insulin after a person has eaten a meal and fills the blood stream with glucose. Lack of physical activity and being overweight increases a person’s risk of developing this type of diabetes.

Sticking to a healthy diet and engaging in physical activity are ways that all people can help prevent or treat diabetes. Also, keeping high blood pressure and cholesterol in check are advisable preventative and curative courses of treatment. A daily dose of aspirin and/or injecting medicine are ways to treat diabetes for those already diagnosed with the disease.

Rheumatoid arthritis (RA) is a systemic chronic autoimmune disease in which the immune system attacks its own body’s joints, and articular tissues (such as skin, the heart and muscles) are often affected as well. Rheumatoid arthritis generally targets the synovial joints, the most moveable joints in the body. The intense pain and possible joint destruction caused by this inflammatory disease can bring about fatigue, stiffness and, if not properly treated, immobility.

Although RA can afflict people of all ages, most patients diagnosed with RA are between the ages of 40 and 50. Women worldwide are diagnosed with RA three times as often as are men. 1% of the world’s population is estimated to suffer from rheumatoid arthritis.
While there may be no cure for RA, there is a wide range of rheumatoid arthritis treatments and therapies that successfully alleviate the pain associated with the disease and help to slow its progression. RA is usually treated with a disease-modifying anti-rheumatic drug (DMARD) and any other needed medications are prescribed in addition. In addition to taking a DMARD, many RA patients take daily doses of cortisone through injection or lower dose pills. Treatment of RA also includes physical exercise and rest.

Check out some of our Rheumatoid Arthritis (RA) Clinical Trials near Birmingham.

Osteoarthritis (OA), also known by the names “degenerative joint disease”, “degenerative arthritis” and “arthrosis”, is an autoimmune disease in which low-grade inflammation results in joint pain and degradation of joints, articular cartilage and subchondrial bone. The pain and inflammation in OA result from arthrosis (wear and tear) of the protective cartilage inside joints. As the cartilage is worn down, it becomes painful for any weight to bear upon the unprotected (and in more severe cases of OA, exposed and degraded) bone. Patients with OA may suffer joint tenderness, stiffness, effusion and locking. Due to the experienced pain associated with moving, OA patients refrain from moving very much, and the lack of movement leads to muscle atrophy. The most common form of arthritis, OA most commonly affects the large weight bearing joints (such as knees and hips), hands, feet and spine. Cold weather and humidity increases symptoms in many OA patients. Check out some of our Osteoarthritis (OA) Clinical Research Trials near Birmingham.

The treatment for mild to moderate cases of osteoarthritis usually involves acetaminophen. Non-steroidal anti-inflammatory drugs (NSAID) are generally prescribed for more severe cases of OA. NSAIDs are more effective in relieving the symptoms of OA but they offer more dangerous side effects than does acetaminophen.

With shocking reports of the overall increase in the rate of obesity in America all over the news and in the media, there has never been a better time for a new diet drug that could actually work for people. There are many clinical trials for obesity and weight loss, but do they produce results? Well, in recent clinical research taking place at the University of Alabama in Birmingham, a new experimental drug called Qnexa has shown some positive signs.

So far, the new diet drug has proven in clinical trials that it can help obese people to not only lose the weight, but also keep it off for two years based on the reports from clinical researchers. Qnexa is a combines the appetite suppressant phentermine with the anti-seizure drug called topiramate to achieve the results.

The primary concern when it comes to developing new weight loss drugs are safety concerns. The Food and Drug Administration (FDA) is very strict when it comes to approving new weight loss drugs for the market. Back in 1997, a weight loss drug known as “fen-phen” had to be withdrawn from the market after it was reported that it could cause fatal heart valve problems. So ever since that event, the issue for pharmaceutical companies has been developing a drug that can be effective and safe.

The road to market approval for Qnexa has by no means been a smooth one. The FDA actually rejected the diet drug last year for safety concerns, which included some clinical participants who experienced elevated rates as well as potential birth defects for pregnant users. Vivus Inc. was able to get the FDA to accept a new application of Qnexa just last month, and now it is seeking final approval to the market.

These latest clinical research studies being conducted for Qnexa are extensions from earlier clinical trials that were done using a placebo test control group. What the research shows is that obese people who take the diet drug, and make some lifestyle changes, will undoubtedly lose more weight in a year than those who took a placebo pill. At the end of two years, the clinical trial participants who took Qnexa had lost about ten percent of their starting weight on average. The people who had been given the placebo lost about 2 percent on average by the end of two years.

Another benefit that appeared during the clinical trials was that the participants who were given Qnexa saw a decrease in their chances of getting diabetes. During the clinical study, their blood sugar and insulin levels dropped. About 4 percent of the participants who were given the placebo developed diabetes per year. Of the participants who were given a higher dose of Qnexa, only 1 percent developed diabetes each year of the study.

Qnexa still faces a bit of an uphill climb before it will be approved for the market. In fact, there is no guarantee it will ever get there. There were some participants who opted out of the clinical trial due to the side effects they experienced on Qnexa. Some people experienced respitory problems, dry mouth, and some tingling sensations. To date, there is only one weight loss drug which has been approved for long term use known as Xenical, and this drug has been known to cause side effects as well. Only the future will tell whether Qnexa can pass the gauntlet and be approved for use in the market.

On January 11, 2010 the Food and Drug Administration (FDA) approved Genentech Inc.’s Actemra (tocilizumab), a drug used to treat adults with average or severe active rheumatoid arthritis and patients two years of age and older who suffer from active juvenile idiopathic arthritis (SJIA). Patients with rheumatoid arthritis have an amplified amount of interleukin-6, a protein of the immune system. Actemra helps to alleviate the swollen joints and ease the pain experienced by such patients by blocking the harmful exploits of this protein. The drug was tested in five rheumatoid arthritis clinical trials to determine its safety and efficacy in adult patients with active rheumatoid arthritis. Actemra proved to better treat the patients’ symptoms than did a placebo in every one of the trials.

Actemra bears the risks of an increase in liver enzymes, elevated low-density lipoprotein (LDL), hypertension and gastrointestinal damage, and is therefore only to be used by patients whose symptoms have not responded well to other available tumor necrosis factor antagonist drugs. Dr. Bob Rappaport, director of the Division of Analgesics, Anasthetics and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research warned, “physicians and patients need to be aware of the risk of serious adverse effects of Actemra and make informed decisions regarding its benefits and risks in the treatment of individual patients.”

For continued evaluation of the safety, efficiency and long-term effects of Actemra, the FDA is mandating that a post-marketing clinical trial be conducted. Other possible side effects of Actemra include headache, upper respiratory tract infection, low platelet count, low neutrophil count, hepatitis B infection becoming an active infection, nervous system complications and inflammation of the nose or nasal passage. Patients who simultaneously take immunosuppressant drugs such as methotrexate or corticosteroids are at risk of developing serious infections such as tuberculosis and infections caused by bacteria or fungi. Since Actemra works on the immune system, there is an increased risk of developing certain cancers.

Financial assistance is offered to those who take Actemra. Consult your healthcare provider and find out if Actemra is right for you. It is important to consider the risks with your healthcare provider before taking Actemra.

You can also check out the other RA Clinical Trials currently enrolling here:

Rheumatoid Arthritis – Vestavia Hills, AL – #35216 (age 18-75)

Rheumatoid Arthritis – Vestavia Hills, AL – #35216 (age 75+)

The entire process of a clinical trial is broken up into four phases, each of which serves the research team a unique purpose in order to better study the products and achieve the protocols.

The first phase of clinical trials consists of about 20-100 participants. This is the first time that the drug or treatment is being evaluated in humans to determine its effectiveness when taken while fasting as opposed to after being fed, its tolerability, side effects and overall safety. These trials are normally conducted in a clinical trial clinic so that the participants can be watched carefully at all times. Phase I may consist of dosage escalation studies so that the researchers can determine the safest dose to administer. In single ascending dose studies, small groups of participants are given a single dose of the drug being studied, and when rendered safe for the dosage to be escalated, different groups of people are given the higher dosages until the maximum tolerated dose (MTD) is attained. In multiple ascending dose studies, a group of patients is given multiple low doses of the drug while having their urine and blood are analyzed at various times, and when the dose is rendered safe for escalation, new groups of participants are given the higher doses up until the MTD is reached.

In Phase II Clinical Studies, groups of 100-300 test the studied drug or treatment to further evaluate its efficacy and potential hazards upon its confirmed safety in phase I. Most of the determined failings discovered about experimental drugs are discovered during the phase, if any are ever found at all. Phase II continues to study the efficacy and required dosage, sometimes by splitting this phase into phases IIA and IIB.

Phase III Clinical Studies, the most well-known of all the phases, are randomized, controlled, large-scale studies that involve 1-3,000 or more participants. These multicenter studies compare the experimental drug to the current FDA-approved treatments. Phase III is the most costly, time-consuming and tedious of all the phases. At this phase, researches observe whether the drug could be used to treat other diseases beyond their original intent. To allow market sales, the FDA typically requires two positive cycles of phase III.

In Phase IV Clinical Studies, ongoing technical support and safety surveillance are performed. The patient population is larger and the phase duration is longer than in the previous three. Harmful effects of the drug observed in phase IV can result in the drug being pulled from the market or being restricted to certain uses.

The purpose of the “fifth phase” is solely to convey the widespread public use of a clinical treatment.