MS Views and News Be empowered with MS views and news. To receive The MS BEACON e-Newsletter, CLICK HERE - -

Visit our MS learning channel on YouTube, which provides hundreds of MS educational videos presented by MS Experts from across the USA. Archived here: www.youtube.com/msviewsandnews -- Also please visit our Social media platforms: Facebook, Twitter, and Instagram . Each providing important information for the MS community. Furthermore, scroll down the left side of this blog to learn from the resources and links.

Disclaimer: 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, for your personal knowledge and to keep you informed of current health-related issues. It is not a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~


Saturday, October 6, 2018

MS in a Child Considerably Affects Quality of Life for Family, Study Reports



Parents of children with pediatric-onset multiple sclerosis (MS) report a lower overall quality of life than those whose kids have a condition marked by demyelination but is not a chronic disease, a study reports. The lifelong nature of MS makes all the difference, it said.
MonoADS, like MS, is caused by demyelination (the loss of the myelin sheet that protects nerve cells) in the brain and spinal cord. But a monophasic disorder is marked by  a demyelination event, while MS is characterized by recurrent demyelinating events.
Researchers used the Pediatric Quality of Life Inventory, (PedsQL) a self-report questionnaire that assesses the quality of life of a child affected by a disease and that of their families. The health-related quality of life (HRQoL) of parents whose children experienced demyelination, of the children themselves, and of adult perceptions of how the disease affects their family were evaluated.
In total, 58 children with MS and 178 with monoADS from across Canada were included in the study; all were followed at given clinics or health facilities for at least five years and up to almost nine years.
HRQoL scores of children with MS in total did not differ from those with monoADS, nor did the groups differ in scores of physical and psychological well-being.
But HRQoL reported by parents of children with MS was significantly lower than that of parents whose children had monoADS, in terms of their physical, emotional, social and cognitive well-being. MS parents also reported greater worry, a poorer sense of communication, and lesser daily activities shared by the family or interaction among members.
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Keep up to date with MS news and information via e-mail.  Click here 
                      
:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Could Government Probe Threaten Pharma Patient Assistance Programs?

 OCTOBER 5, 2018



Could Government Probe Threaten Pharma Patient Assistance Programs?

Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened.
A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong side of the law. These include direct copay assistance, donations to foundations that help patients pay for their meds, and even the practice of making healthcare professionals available 24/7 to answer patients’ questions.
The concern is whether these services promote the sale of the companies’ medications. If they do, they could be considered illegal. Investigators will look at whether the services violate a federal statute barring payments that prompt the prescribing of medications or other medical care that’s reimbursed by government health programs.
The Journal named Sanofi and Biogen as being among several pharmaceutical manufacturers being probed. Sanofi makes the MS medications Aubagio (teriflunomide) and Lemtrada(alemtuzumab). Biogen makes Tysabri (natalizumab), Avonex(interferon beta-1a), Tecfidera (dimethyl fumarate), and Plegridy(peginterferon beta-1a).
I’ve been treated with Avonex (I was in the original Phase 3 clinical trial), Tysabri, Aubagio, and Lemtrada. I received copay assistance from a foundation when I was being treated with Aubagio. I could not have afforded its copay without that assistance.

What is the government doing?

In the case of Sanofi, the Journal reports that government investigators have asked for information about the company’s “certified diabetes educator program.” That program, which Sanofi says is no longer active, answered questions from people with diabetes and helped them to use the company’s diabetes treatments.
It seems similar to Sanofi Genzyme’s “MS One to One” program for multiple sclerosis patients. Since I’m currently being treated with Lemtrada (and I’ve previously used Aubagio), I’ve interacted with “One to One” nurses. They follow my lab work and track any adverse effects the medication may have had on me. That tracking involves a Risk Evaluation and Mitigation Strategy that the Food and Drug Administration has required Sanofi Genzyme to implement.
(Full disclosure: In 2017, I was a paid participant in a group of social media influencers who spent a day advising Sanofi Genzyme marketing, P.R., and social media teams about communicating with MS patients.)
Similarly, according to the newspaper, Biogen has received a civil investigative demand for information about its relationships with “entities providing clinical education and reimbursement support services,” according to securities filings by Biogen last year. That sounds like Biogen’s patient assistance service called “Above MS.”

What’s the problem with support services?





::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

To receive MS news and information via e-mail, Please Click here 
                     
:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Tysabri Seen to Improve Cognition in RRMS Patients Over 2 Years in Retrospective Study


Tysabri (natalizumab) was reported in a small retrospective study to significantly improve cognitive abilities in people with relapsing-remitting MS patients (RRMS) over two years of use.
About 40-65% of MS patients have cognitive impairment, one of the disease’s most disabling symptoms. It strongly affects patients’ quality of life, in both their personal and professional areas, and can impact their employment prospects.
NeuroTrax is a validated computerized screening test of cognition that provides a global score based on seven domains — executive function, memory, attention, visual-spatial processing, information processing speed, verbal function, and motor function.
A large-scale study using NeuroTrax showed that MS patients have poorer cognitive abilities than healthy people, particularly in areas involving information processing speed and executive function — and such problems worsen with disease duration. The test is rarely used, however, to assess treatment response in MS patients.
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Learn more about MS, Please Click here 
                     
:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Staying Positive While Living with a Chronic Illness [Sponsored Post]

 SEPTEMBER 17, 2018

Life is unpredictable. Some days things might be going great and then, out of nowhere, you are thrown a curveball. These moments when I am confronted by life’s challenges often leave me feeling helpless and wondering, ‘Why is this happening to me?’
It started in 2011, when I thought I had my life all figured out. At the time, I was working towards a master’s degree, married and had two beautiful children whom I adored – needless to say, things were going great!
But life’s unpredictable nature awakened and sure enough, towards the end of that year, I began experiencing strange aches and pains down my arm and neck. These aches and pains progressed, and one day at work, my feet and waist went numb, followed by an electric shock down my spine when I bent my neck. I immediately had a feeling that one of life’s curveballs was heading my way. I made an appointment with my primary care physician and after a series of MRIs, I was diagnosed with relapsing multiple sclerosis (RMS).  
As a self-described “control freak” and someone who always had things figured out, I was in shock and in denial. This was a situation that I had no power over. But after a week, my can-do, persevere-through-anything attitude took over. Rather than waste my time wallowing, I decided to deal with this stressful moment in the best way that I could – remain positive. 
Looking back, I have learned a variety of lessons that helped me stay positive and keep myself on track – in life and in my RMS journey. Here are a few:

Read more


How B-cells Work to Promote T-cell Attacks on Myelin That Lead to MS Detailed in Study



B-cells in the immune system play an important role in the unfolding of inflammation and brain lesions in multiple sclerosis(MS), largely by how they influence the actions of another immune system cell, called T-cells, a new study reports.
Its findings help explain why therapies like Ocrevus and off-label use of rituximab, both of which act on B-cells, are effective in controlling MS.
Despite advances in understanding MS, it is still unclear exactly which specific cells and molecules drive the immune system to attack healthy tissue and damage the protective myelin layer surrounding nerve cells in the brain and spinal cord.
A team of researchers at the University of Zurich and the Karolinska Institute in Sweden report that memory B-cells, so-called because they normally work to remind the immune system of past threats so that such invaders (like viruses) are stopped quickly, also cause autoreactive T-cells to proliferate in MS patients. Once these cells reach the brain, they promote inflammation and demyelination (loss of myelin).

Local Motorcyclists Riding 5,000 Miles in 50 Days for MS

(Silver City, NM, October 1, 2018) – Local endurance motorcycle riders take up the “cause.” Grant County residents, Yancey and Karen McCauley, are competing in a national challenge to ride their motorcycles 5,000 miles in 50 days while raising money to benefit people living with Multiple Sclerosis (MS). The money raised will go to MS Views and News, an organization that helps to raise awareness about MS and treatment options in rural communities. The McCauleys will donate tires, gas, and time towards raising awareness for MS. You can help by donating to the cause here and selecting either Yancey or Karen’s name from the drop down list of riders. All donations are tax deductible. In addition, Freeport-McMoRan employees can apply for matching funds.
Yancey and Karen McCauley started long distance motorcycle riding in 2014. Since then their passion for motorcycling has grown. Karen and Yancey are also members of the Iron Butt Association. They have competed across the country in long distance endurance events and have motorcycled in 38 states so far. Some of their long distance endurance events include: 2018, 2017 and 2016 Tour of Honor, 2018 Butt Lite Rally IX, and 2017 How the West Was Won.




Yancey will be riding either his 2014 Indian Roadmaster or his 2003 Suzuki VStrom. Karen will be competing on her 2014 Can-Am Spyder or her 2012 Honda Rebel 250. Yancey works at the Tyrone Mine, and Karen works as a teacher at Cobre High School.
MS affects some dear friends and families in the area. Be a part of raising money and awareness for a great cause.

Article source found here

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

To receive MS news and information via e-mail, Please Click here 
                      
:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Friday, October 5, 2018

Spasticity and MS: How to Control Your Muscles

Many people with multiple sclerosis have stiff muscles and spasms, a condition called spasticity. It happens mostly in the muscles of the legs and arms, and it may keep you from moving your limbs freely.
 
You might feel spasticity either as stiffness that doesn’t go away or as movements you can’t control that come and go, especially at night. It can feel like a muscle tightening, or it can be very painful. Spasticity also can make you ache or feel tight in and around your joints and low back. How you feel can vary depending on your position, posture, and how relaxed you are.

What Causes Spasticity?

Spasticity happens because of an imbalance in the electrical signals coming from the brain and spinal cord, often when multiple sclerosis has damaged the nerves there. This unevenness makes your muscles contract on their own and makes them tense.

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

To receive MS news and information via e-mail, Please Click here 

CLICK BOX to SUBSCRIBE to our MS Learning Channel on YouTube: 

                      
:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

How to Talk to Your Kids About MS

Once you learn you have multiple sclerosis (MS), it may take you some time to adjust to your symptoms and to know what to expect from your disease. The same goes for your children. They might be even less sure of what to expect than you are. They might also feel scared, sad, angry, or helpless about your diagnosis.
The most important thing to do is to talk to your children about how MS affects you and see what they’re thinking. Open communication can help you ease their fears, answer their questions, and let them know how you feel.

Starting the Conversation

Before you sit down with your child, think about her age, maturity level, and how much you think she can understand about your disease. If you have more than one child, it may be helpful to talk to them individually so you can make the discussion right for each of them.

Don’t be surprised if your kids already know that something is up before you talk about it with them. Children of all ages are good at knowing when things are different. But you may want to ask them how they would like to learn more about MS. They can start by reading a book alone or with you, watching a video, or going with you to a doctor's visit.

Children's Reactions to Multiple Sclerosis

Sometimes normal emotions like fear, sadness, or guilt may lead to changes in a child’s behavior. Here are some signs to watch for in your child:
  • More focus on her own body and wellness
  • Not wanting to spend time with close friends
  • Higher anxiety and stress
  • Trying to act older or younger than she is
  • Behaving badly in public
  • Lying to friends about your illness
  • Temper tantrums
  • Waiting until you’re tired at the end of day to ask for things (such as help with homework)
  • Doing poorly in school
  • Nightmares, bed-wetting, and trouble falling asleep.
You may want to get professional help for your child if he  or she:


::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

To receive MS news and information via e-mail, Please Click here 
                      
:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Health Literacy Month: How to Talk with Your Doctor about MS Research By Nancy Ryerson

Health Literacy Month: How to Talk with Your Doctor about MS Research

By Nancy Ryerson

Have you ever felt confused by your doctor’s instructions? If so, you’re not alone. Today, 90 million Americans struggle with what healthcare professionals call low health literacy. Many patients struggle to follow directions on a medicine bottle or understand their doctor.

In honor of Health Literacy Month, we’re sharing a few ways you can have a better conversation with your doctor about MS research in particular.

Unfortunately, patients with low health literacy also tend to have worse health in general. They’re more likely to be admitted to the hospital, and have higher healthcare costs, too.

The problem also impacts clinical trial participation, which can be important for MS patients. Studies show that patients who aren’t sure what “clinical trial” and “clinical research” mean are also less likely to participate in trials.

Clinical trials research potential new treatments for conditions like MS. New medications can’t reach patients without clinical trial volunteers. If you’re interested in participating, researchers list MS trials on ClinicalTrials.gov. Because it was built for researchers, the website can be difficult for patients to use. To make the process easier, MS Views and News has a clinical trial search tool that makes it easier for people with MS to find clinical trials matches.

If you do find a clinical trial you’re interested in, share it with your doctor. Ask any questions you have about the trial. If you’re looking for ideas, here are few questions to consider:

     Do I qualify for this trial? Why or why not?
     How would this trial fit with my existing treatment?
     Do you recommend I apply for this trial? Why or why not?

Some patients with MS may feel concerned about joining a clinical trial because they don’t want to receive a placebo, or “sugar pill.” Not all clinical trials use placebos. Many measure the effectiveness of a potential new treatment against a treatment that’s already available. In 2001, the National MS Society published recommendations related to the use of placebos in MS clinical trials. The report outlines when it’s ethically okay to use a placebo in a MS trial, and when trials should find alternatives.

As you review a clinical trial with your doctor, ask for help understanding whether the trial will use a placebo, if it’s not clear from the trial listing. If you decide to go to the study site to learn more about the trial, you can also ask many more questions about the trial there. These questions can include:

     How long will the study last?
     What is the goal of the study?
     Will I be reimbursed for my expenses?
     What can I expect at each study visit?
     What did previous studies find out about the treatment? Have the results been published?
     What are the potential risks and benefits of taking the study drug?
MS is a difficult diagnosis to navigate, and chances are, you have questions every time you talk with your doctor. Even if you feel confused or unsure during your appointment, remember that many other patients feel that way, too. Ask your doctor for help, and empower yourself to seek better care.



::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

To receive MS news and information via e-mail, Please Click here 


What is a clinical trial?

Clinical trials are research studies that test whether a new potential therapy is safe and effective for patients. They evaluate new drugs, behaviors, or devices, and reveal whether these potential therapies work for particular illnesses or particular groups of patients. Clinical trials provide the best available data with which to make healthcare decisions, and are considered the gold standard in the development of new therapeutic options.
There are two main types of clinical trials: interventional studies and observational studies:
  • Interventional studiesThese are clinical trials testing whether a specific intervention (such as a drug, device, or behavioral change) affects health-related outcomes. Different groups of people are assigned at random to receive and not receive the intervention in a process called randomization. Typically the group that does not receive the intervention — also known as the control arm — receives either the current standard of care or a placebo (a fake version of the intervention), depending on the condition. It's important to note that trials for life-threatening conditions such as cancer will not offer a placebo. Interventional trials are also typically blinded, meaning that the volunteer is not aware if they are in the control group or receiving the intervention, or double blinded, meaning that both the researcher and the volunteer are not aware.
  • Observational studies. These studies, on the other hand, are ones in which participants are put in groups based on their characteristics, and an intervention is tested in each of these groups. The difference is that the groups are assigned based on volunteer characteristics, rather than at random. Both types of studies follow a protocol, a detailed plan for the study written by the trial sponsor and approved by the FDA.
A trial sponsor is an organization which initiates, funds, and conducts a clinical trial. This is often a pharmaceutical company, but it can also be a university or another type of research organization. When selecting a clinical trial, it's important that potential volunteers are fully aware of and comfortable with who is sponsoring the trial.
Potential volunteers for trials can be anyone. While many people view clinical trials as a last resort only to be relied upon when all other options have been exhausted, this is not the case; research studies need a variety of participants to enroll. Some trials are looking for volunteers who have been recently diagnosed, while others may be only need those who have been living with a condition long-term. Certain studies may require patients who have had different treatment experiences in the past. Every trial is different, but with thousands of studies recruiting, there is likely a trial that is right for you.

What are the phases of clinical trials?

Clinical trials begin with an idea in a lab. Researchers thoroughly test potential treatments in the lab and in animals before ever beginning trials in humans. If these lab and animal tests are successful and the therapy looks promising, the researchers will begin to conduct research studies beginning at Phase 1 and moving through to Phase IV:
  • Phase I clinical trials test whether drugs are safe to use in humans.
  • Phase II clinical trials test the effectiveness of a drug or medical device. This stage can last from several months to a few years, and generally involves several hundred participants.
  • Phase III clinical trials are typically the largest. They involve anywhere from several hundred to several thousand participants in a randomized, blind study. This testing phase can last several years as the FDA gathers thorough data about the drug's effectiveness and potential side effects.
  • Phase IV trials, also known as Post Marketing Surveillance Trials, take place after a drug or device has been approved. In this phase, pharmaceutical companies monitor a drug's long-term effectiveness and impact, compare it to existing trials in the market, and determine the cost effectiveness of the new treatment.
It's a big decision to take part in a clinical trial, and it's important that patients and caregivers fully understand all of the benefits and risks before enrolling. We'll discuss these in the next section.

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

To receive MS news and information via e-mail, Please Click here 
                      
:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

How do clinical trials work?

During a trial, volunteers receive an intervention based on a clinical trial protocol put together by the researchers running the study. This means they'll either receive the new treatment or device being tested, or they will receive a placebo (no active ingredients) or the current standard of care, depending on the condition. In some cases, participants may receive the standard of care and a placebo, if the trial is testing a treatment to alleviate side effects or a particular symptom. For life-threatening illnesses with available treatment, such as cancer, placebos are not used.
As the treatments are administered to the volunteers, the researchers measure outcomes — things like how the patient feels, changes in symptoms, decrease in spread of disease, etc. These measurements help them determine the efficacy of the trial — that is, whether the treatment or device being evaluated works to improve outcomes as anticipated. Researchers also keep careful track of how volunteers react to the treatments being tested in order to determine the safety of the intervention as well.

Preclinical studies: Before trials start

Before researchers begin testing a potential new treatment in people, extensive research is conducted to decide whether the drug is a good candidate for clinical trials. Testing includes in vitro (in a test tube or cell culture) as well as in vivo (animal) experiments. For some drugs, researchers are able to perform drug profiling using computer models that show how the drug will interact with the human body.
Preclinical research may take anywhere from one to six years. Researchers only take the most promising potential treatments to the next phase.

What is the goal of a clinical trial?

An investigational clinical trial will set out a goal before the trial launches. A trial's goal may be to compare effectiveness between an existing treatment and a potential new drug or device, to treat specific symptoms, or to delay or prevent disease progression. A trial may have a primary goal as well as a secondary goal. For example, the primary goal of a Parkinson's disease trial may be to treat a particular symptom such as tremor, but the secondary goal may be to slow disease progression, as well.
Beyond the overall goal of a clinical trial, each trial phase has goals to meet, as well, which we will outline in the next sections.

Phase 0

A relatively new step in the clinical trial process, this early stage is intended to quickly weed out ineffective drugs, or establish that a drug will work as expected in the body.
This stage only enrolls a few volunteers, who are given just 1% of the dose of the drug being researched. Phase 0 trials take no more than seven days.
These short trials give researchers a sense of how the drug will behave in the body. This phase is not required by the FDA, but is suggested particularly for drugs that aim to treat serious diseases.

Phase 1: Testing for safety

The first official stage of a clinical trial researches a potential new treatment for safety. These trials enroll around 20 to 100 volunteers, and last from a few months to a year. Because this phase measures safety by testing for any adverse side effects of the treatment, and not how effective the drug or device is, the trial may enroll only healthy volunteers without the condition. The trial may also enroll patients with the condition the trial aims to treat, but treating symptoms is not the goal of this phase.
During this phase, researchers start with small doses of the drug and measure how the body responds to determine the ideal dosing. They also check for side effects.
Because this is typically the first time the investigational drug is tested in humans, it is the highest-risk clinical trial to take part in. For that reason, Phase 1 trials are also the most common paid clinical trials.
If the researchers determine that the treatment is safe enough, it moves into the next phase. Around 70% of treatments in development move on to Phase II trials.

Phase 2: Testing for safety and effectiveness.

The next clinical trial phase continues to test for safety, while measuring the effectiveness of the treatment for symptoms, as well. Phase 2 trials enroll up to several hundred volunteers living with the condition. This phase can last from several months to a few years.
Phase 2 trials are typically randomized. This means that one group of participants receives the study drug, while others receive a placebo or the standard of treatment. Placebos are not used in Phase 2 cancer trials.
Most Phase 2 trials are also blinded, meaning that neither the researchers nor the participants know to which treatment branch patients have been assigned.
A potential treatment can only move on to the next phase if it is found to be effective. Around 33% of study drugs pass this phase.

Phase 3: Testing for safety and effectiveness with many patients

The largest clinical trial phase, these studies enroll hundreds of participants to test a potential treatment for effectiveness, while continuing to monitor safety and side effects. This phase may last for several years, as the FDA requires a large amount of information to weigh benefits against side effects.
Approximately 25 to 30% of treatments that enter this phase move forward in the approvals process. At this point, the drug or device sponsor applies for a New Drug Application (NDA) with the FDA.
The FDA decides whether or not to approve the NDA based on the results from all previous clinical trials. If the FDA determines that the benefits of the treatment outweigh the risks, the drug is approved, and the pharmaceutical company may begin marketing the drug.

Phase 4: Post-marketing trials

After a new treatment is approved by the FDA, the pharmaceutical or device company may want to continue monitoring patients to learn more about the treatment’s longer-term effects, while comparing the it against other already-approved options.
It may take time for long-term side effects to appear, making this an important phase, too.

Learning more: Phases 2b and 3b

Sometimes, researchers want to learn more about an investigational treatment before moving it into Phase 3 testing, the largest and most expensive phase. Phase 2b trials give sponsors the opportunity to rigorously demonstrate the effectiveness of a potential new treatment.
In some cases, a Phase 2 may be broken into two sections: the A trial investigates the best dosing for the treatment, then the B trial measures how effective the treatment may be.
For Phase 3 trials, 3a studies take place before FDA approval, and IIIb studies are conducted after. Post-approval studies may further research how the treatment impacts quality of life, for example.

How do medical device clinical trials work?

Medical devices must also be approved for use, but go through a somewhat different process. Devices are not tested on people without the condition. Instead, they are tested first for safety and performance in what is called a "pilot" or feasibility study with a small group of patients, typically 10 to 30. Next, a "pivotal" trial enrolls a larger population of patients, from 150 to 300 participants, to further test safety and effectiveness. Post-approval studies collect long-term information, like post-marketing studies for drug trials do.
Unlike drug trials, medical device trials are not able to use a placebo. Another difference is that many drug trials are blinded, in which neither the researcher nor the participant known which branch the patient is in. But for medical device trials, that is typically impossible to do. Instead, new medical devices are typically measured against the existing standard of care.
Not all new medical devices need to go through clinical trials. Some are quite simple and considered low-risk, such as new bandages or tongue depressors, which are both considered medical devices. Medical devices are broken into classes. Class I devices pose a minimal risk, Class II are Intermediate Risk, and Class III devices are Substantial Risk. Class III devices always require a clinical trial, and sometimes Class II devices do, as well.

What is the approval process for generic drugs?

When a new drug or device is first approved, the sponsor receives exclusivity on the drug for a period of time in order to recoup the cost of developing the drug. The length of time that a drug maintains exclusivity varies, but in most cases, a new brand-name drug receives exclusivity for five years. with the intention that the company will recoup the costs of developing the treatment.
After that, other companies are able to submit generic versions of the drug for approval. The company must show their manufacturing process for creating the drug, so the FDA can confirm that the manufacturer can make a high-quality product.
The FDA will also review results from additional clinical trials that test the generic drug against the brand-name drug, comparing data to ensure that the generic drug is safe, effective, and can be substituted for the original drug.

How long does clinical research take?

Including preclinical research, a new drug's journey from the lab to pharmacy shelves can take up to 11 years. Post-marketing research may add another few years to the process, as well.
Unfortunately, up to 80% of clinical trials are delayed because of recruitment challenges – that's why it's so important for interested patients to take part in research opportunities. Today, nonprofit research organizations, patient advocates, and organizations like Antidote are working to raise clinical trial awareness and connect patients with trials that are right for them.
CONTINUE reading by clicking here



::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

To receive MS news and information via e-mail, Please Click here