How Does That Work Again?

I’ve had so many questions lately about how clinical trials work that when Antidote asked me if I’d consider including their infograph in a blog, I jumped at the chance. There’s even more information about clinical trials at https://www.antidote.me/what-are-clinical-trial-phases.

I’ve written about Antidote before… and I’ve written about clinical trials before. It seems more and more people are becoming interested in the process for a multitude of diseases, not only Chronic Kidney Disease.

As a newly diagnosed diabetes patient, I’ve noticed clinical trials for diabetes. A family member has Alzheimer’s; his neurologist keeps an eye out for clinical trials for him. Whatever your disease is, you can search for clinical trials.

While this is not everyone’s cup of tea, it is a chance to help others who may develop the same diseases in the future. Who knows, maybe the new treatment will be FDA approved during your own lifetime and help you with your own disease.

In case you are one of those people who have always wondered just what the FDA is, their website is https://www.fda.gov. That’s right: it’s a government site which is part of the U.S. Health and Human Services. What’s that? You’d like a more precise definition?

No problem. This is from the United States of American Government website at https://www.usa.gov/federal-agencies/food-and-drug-administration and offers basic information about the FDA.

Food and Drug Administration

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.

                                                                                                                                                      Agency Details

Acronym: FDA

Website: Food and Drug Administration (FDA)

Contact: Contact the Food and Drug Administration

 Report a Problem with a Product

Main Address: 10903 New Hampshire Ave.
Silver Spring, MD 20993

Toll Free: 1-888-INFO-FDA (1-888-463-6332)

Forms: Food and Drug Administration Forms

Government branch: Executive Department Sub-Office/Agency/Bureau

By the way, they are also responsible for both recalls and safety alerts for the treatments they’ve approved.

In the infograph above, you’ll notice, “Sometimes, only healthy volunteers participate.” in Phase 1. Should you decide to apply for a clinical trial, you need to keep this in mind to save yourself a bit of heartache. I firmly believe in paying back for the wonderful things in my life and have applied for several clinical trials for other diseases in an effort to do so. I must have missed the small print because I was rejected for having CKD.

I wanted to help eradicate or ameliorate whatever the disease was. Sometimes it was a disease that was ravaging a loved one. It was just a little bit of a heartbreak not to be able to do so.

As for Phase 2, I went to the blog’s site at gailraegarwood.wordpress.com to use the antidote widget at the bottom of the right side of the page. It’s the turquoise one. You can’t miss it. Face Palm! You can also go directly to www.antidote.me to search for clinical trials.

Why Antidote? It’s simply an easier way to find a clinical trial. This is from SlowItDownCKD 2017:

“Antidote Match™

Matching patients to trials in a completely new way
Antidote Match is the world’s smartest clinical trial matching tool, allowing patients to match to trials just by answering a few questions about their health.

Putting technology to work
We have taken on the massive job of structuring all publicly available clinical trial eligibility criteria so that it is machine-readable and searchable.

This means that for the first time, through a machine-learning algorithm that dynamically selects questions, patients can answer just a few questions to search through thousands of trials within a given therapeutic area in seconds and find one that’s right for them.

Patients receive trial information that is specific to their condition with clear contact information to get in touch with researchers.

Reaching patients where they are
Even the smartest search tool is only as good as the number of people who use it, so we’ve made our search tool available free of charge to patient communities, advocacy groups, and health portals. We’re proud to power clinical trial search on more than a hundred of these sites, reaching millions of patients per month where they are already looking for health information.

Translating scientific jargon
Our platform pulls information on all the trials listed on clinicaltrials.gov and presents it into a simple, patient-friendly design.

You (Gail here: this point is addressed to the ones conducting the clinical trial) then have the option to augment that content through our free tool, Antidote Bridge™, to include the details that are most important to patients – things like number of overnights, compensation, and procedures used. This additional information helps close the information gap between patients and researchers, which ultimately yields greater engagement with patients.

Here’s how Antidote Match works
1. Visit search engine → Patients visit either our website or one of the sites that host our search.
2. Enter condition → They enter the condition in which they’re interested, and begin answering the questions as they appear
3. Answer questions → As more questions are answered, the number of clinical trial matches reduces
4. Get in touch: When they’re ready, patients review their matches and can get in touch with the researchers running each study directly through our tool

Try it from the blog roll. I did. I was going to include my results, but realized they wouldn’t be helpful since my address, age, sex, diseases, and conditions may be different from everyone else’s. One caveat: search for Chronic Renal Insufficiency or Chronic Renal Failure (whichever applies to you) rather than Chronic Kidney Disease.”

Before I sign off, this came in from the American Association of Kidney Patients:

Please join us on Tuesday, October 9, 2018 at 1 p.m. ET for an educational webinar on Making the Perfect Team: Working with Your Dialysis Technician in partnership with National Association of Nephrology Technicians/Technologists (NANT).  Keep in mind that’s tomorrow. Hit this link if you’d like to register https://register.gotowebinar.com/register/7744206034004582403

Until next week,

Keep living your life!

Not That Kind of Trial

I enjoy reading murder mysteries and thrillers, especially Victorian era ones like the work of Anne Perry.  Sometimes they include –  or even start with – the trial and work their way backwards to the crime. The trial. That got me to thinking about a different kind of trial: clinical trials. How did they begin? What are they? WHY are they?

According to the National Institutes of Health (part of the U.S. Department of Health and Human Services) at https://www.nhlbi.nih.gov/studies/clinicaltrials/:

“Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making.

The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas.

If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it’s harmful. However, an approach that works well in the lab or animals doesn’t always work well in people. Thus, research in humans is needed.

For safety purposes, clinical trials start with small groups of patients to find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about the new approach’s risks and benefits.

A clinical trial may find that a new strategy, treatment, or device
• improves patient outcomes;
• offers no benefit; or
• causes unexpected harm

All of these results are important because they advance medical knowledge and help improve patient care.”

That seemed to answer my last question, too, since their purpose is safely test new drugs or therapies.

Are these something recent? Something developed since the Federal Drug Administration (FDA) was instituted? No, they are far, far older. This is from Dr. Arun Bhatt’s Evolution of Clinical Research: A History Before and Beyond James Lind, which you can find at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/. I found it fascinating.

“The world’s first clinical trial is recorded in the ‘Book of Daniel’ in The Bible…. This experiment resembling a clinical trial was not conducted by a medical, but by King Nebuchadnezzar a resourceful military leader…. During his rule in Babylon, Nebuchadnezzar ordered his people to eat only meat and drink only wine, a diet he believed would keep them in sound physical condition…. But several young men of royal blood, who preferred to eat vegetables, objected. The king allowed these rebels to follow a diet of legumes and water — but only for 10 days. When Nebuchadnezzar’s experiment ended, the vegetarians appeared better nourished than the meat-eaters, so the king permitted the legume lovers to continue their diet…. This probably was the one of the first times in evolution of human species that an open uncontrolled human experiment guided a decision about public health.”

Well, then, who is this James Lind mentioned in the title of Dr. Bhatt’s paper? I turned to England’s The Museum: Brought to Life at http://broughttolife.sciencemuseum.org.uk/broughttolife/people/jameslind for the answer:

“The Scottish surgeon James Lind was born in Edinburgh and served an apprenticeship at the Edinburgh College of Surgeons. He then worked as a ship’s surgeon until he opened his own practice in Edinburgh in 1748. Lind discovered the use of citrus fruit as a cure for scurvy when he conducted an early clinical trial. While working as a naval surgeon, Lind encountered cases of scurvy, a disease which often struck sailors on long voyages. The cause, a lack of essential vitamins, was unknown at the time. Earlier doctors had suggested that fresh fruit could be used to treat scurvy, but Lind was the first to test the effects of different diets systematically on a group of patients in a clinical trial. In 1754 he began to feed 12 scurvy patients different foods and found that patients eating citrus fruits such as lemons and oranges recovered much faster than those who were given other kinds of food.”

And now? Why are clinical trials important to us as kidney patients? In this year’s May 21st blog (Use the topic dropdown to the right of the blog itself; it’s easier than scrolling through all the blogs.), I wrote about the benefits of All of Us Research Project. The following is from that blog.

“The goal is to advance precision medicine. Precision medicine is health care that is based on you as an individual. It takes into account factors like where you live, what you do, and your family health history. Precision medicine’s goal is to be able to tell people the best ways to stay healthy. If someone does get sick, precision medicine may help health care teams find the treatment that will work best.

Researchers Share Discoveries

Research may help in many ways. It may help find the best ways for people to stay healthy. It may also help create better tests and find the treatments that will work best for different people.”

KidneyX is also involved. On June 24th (Use the topic dropdown again.), I included their principles in the blog.

Principles

  • Patient-Centered Ensure all product development is patient-centered
  • Urgent Create a sense of urgency to meet the needs of people with kidney diseases
  • Achievable Ground in scientifically-driven technology development
  • Catalytic Reduce regulatory and financial risks to catalyze investment in kidney space
  • Collaborative Foster multidisciplinary collaboration including innovators throughout science and technology, the business community, patients, care partners, and other stakeholders
  • Additive Address barriers to innovation public/private sectors do not otherwise
  • Sustainable Invest in a diverse portfolio to balance risk and sustain KidneyX”

Did you notice that first principle: patient-centered? Or the fifth one: collaborative? We are included in that; we’re the patients.

IDEA Lab is one of the U.S. Department of Health and Human Services’ partners. This is how they define themselves:

‘We test and validate solutions to solve challenging problems in the delivery of health and human services.’”

I know, I know. Now you want to know where you can join clinical trials. How about Antidote? You can go to their website at https://antidote.me/match/search/questions/1?utm_campaign=unisearch&utm_source=slowitdownckd_com&utm_medium=ctsearch&utm_content=no_js or use the widget to the bottom right of the blog. If you’d like a bit more information, I wrote about them on Oct. 7th, 2017 (Use the month dropdown if you’d like to read that blog.)

I could go on and on, but I think you get the idea… and I’ve run out of space.

Until next week,

Keep living your life!

Helping Where You Can

When my brothers made it public that they each had Parkinson’s’ Disease several years ago, I decided to see how I could help. They were being well taken care of by their wives and their medical teams, so they didn’t need my help. Maybe I could help others, I reasoned. So I began exploring ways I might be able to do that… and found one.

It was clear clinical trials with people of my heritage were being conducted and needed participants. It wasn’t clear what these studies entailed. They weren’t reader friendly enough for me to understand, but after multiple emails and phone calls asking for clarification, I finally understood. During the whole process, I kept thinking to myself that this was a wonderful way to help if only it were more accessible – meaning more easily understood.

A couple of weeks ago, Antidote Match approached me about carrying their widget on my blog roll. If you look at the bottom of the lists on the right side of the blog, you’ll see it in turquoise. Actually, I chose turquoise because you just can’t miss that color.

According to the National Institutes of Health (part of the U.S. Department of Health and Human Services) at https://www.nhlbi.nih.gov/studies/clinicaltrials/ :

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making.

The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas.

If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it’s harmful. However, an approach that works well in the lab or animals doesn’t always work well in people. Thus, research in humans is needed.

For safety purposes, clinical trials start with small groups of patients to find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about the new approach’s risks and benefits.

A clinical trial may find that a new strategy, treatment, or device
• improves patient outcomes;
• offers no benefit; or
• causes unexpected harm

All of these results are important because they advance medical knowledge and help improve patient care.

Important, right? But why Antidote Match, you ask? That’s easy: because it’s easy. The information offered is in lay language, the common language you and I understand, rather than in medicalese. Maybe I should just let them present their own case.

Antidote Match™

Matching patients to trials in a completely new way
Antidote Match is the world’s smartest clinical trial matching tool, allowing patients to match to trials just by answering a few questions about their health.

Putting technology to work
We have taken on the massive job of structuring all publicly available clinical trial eligibility criteria so that it is machine-readable and searchable.

This means that for the first time, through a machine-learning algorithm that dynamically selects questions, patients can answer just a few questions to search through thousands of trials within a given therapeutic area in seconds and find one that’s right for them.

Patients receive trial information that is specific to their condition with clear contact information to get in touch with researchers.

Reaching patients where they are
Even the smartest search tool is only as good as the number of people who use it, so we’ve made our search tool available free of charge to patient communities, advocacy groups, and health portals. We’re proud to power clinical trial search on more than a hundred of these sites, reaching millions of patients per month where they are already looking for health information.

Translating scientific jargon
Our platform pulls information on all the trials listed on clinicaltrials.gov and presents it into a simple, patient-friendly design.

You (Gail here: this point is addressed to the ones conducting the clinical trial) then have the option to augment that content through our free tool, Antidote Bridge™, to include the details that are most important to patients – things like number of overnights, compensation, and procedures used. This additional information helps close the information gap between patients and researchers, which ultimately yields greater engagement with patients.

Here’s how Antidote Match works
1. Visit search engine → Patients visit either our website or one of the sites that host our search.
2. Enter condition → They enter the condition in which they’re interested, and begin answering the questions as they appear
3. Answer questions → As more questions are answered, the number of clinical trial matches reduces
4. Get in touch: When they’re ready, patients review their matches and can get in touch with the researchers running each study directly through our tool

A bit about Antidote
Antidote is a digital health company on a mission to accelerate the breakthroughs of new treatments by bridging the gap between medical research and the people who need them. We have commercial agreements with the majority of the top 25 pharmaceutical companies and CROs, and a partner network that is growing every day.

Antidote was launched as TrialReach in 2010 and rebranded to Antidote in 2016. We’re based in New York, NY and London, U.K. For more information, visit www.antidote.me or contact us at hello@antidote.me.

Try it from the blog roll. I did. I was going to include my results, but realized they wouldn’t be helpful since my address, age, sex, diseases, and conditions may be different from everyone else’s. One caveat: search for Chronic Renal Insufficiency or Chronic Renal Failure (whichever applies to you) rather than Chronic Kidney Disease.

On another note entirely: my local independently owned book store – Dog Eared Pages – in Phoenix has started carrying the SlowItDownCKD series. Currently, they have 2016 in stage. I had a wonderful time reading from my novel Portal in Time there last Thursday night and was more than pleasantly surprised at the number of CKD awareness contacts I made.
Until next week,
Keep living your life!

Maybe It’s Not That Hippy Dippy

I just spent the loveliest three days out of town – in Bisbee, Arizona – and out of touch.  I heartily recommend doing this a few times a year.  Talk about the relaxing we CKDers are supposed to be doing!  That’s also the reason for such a late blog today.  We got home fifteen minutes ago, threw in the wash, threw out the garbage and here I am. Before we officially begin, I’ve got to say that I have been getting some really complimentary comments… in spam!  I’ve mentioned before that I’m having a hard time separating the spam from the “real” comments, so if yours has not been responded to yet, kindly comment again but from a different email address, or don’t include your website address.  One of those two actions should allow your comment through.

I always thought of myself as a wannabe hippy in the ’60s.  You know, the ones who were attracted to some of the hippy thinking but couldn’t quite bring themselves to tune in and drop out or live on a commune.  Now, my fiance and I laugh about the retired lieutenant colonel and the wannabe hippy getting together later in life.  What’s even better is that later in my life, the alternative medicine I shocked my parents and colleagues by believing in and practicing is now becoming complementary medicine.  I’ve written about this in the book, but now Catherine Pearson of The Huntington Post has written about it, too. Nontraditional medical courses like this are becoming more common and are also offered through many online PhD programs for those with careers looking to incorporate Integrative Medicine into their practices.

How Mainstream Medicine Is Opening Up To Integrative Health

When students elect to spend a month learning about integrative medicine at the University of Maryland, they study by working with the toughest, most frazzled patients: themselves.

In their fourth year of medical school, many of the students are exhausted and fighting to get good grades. They’re tired; they experience headaches and back pain; and they don’t feel as sharp as they’d like.

But these students aren’t focusing on what drugs to prescribe. Instead, they’re looking at integrative therapies in search of better health.

Under the direction of Dr. Delia Chiaramonte, University of Maryland Center for Integrative Medicine’s director of professional education, the students make a values list, which Chiaramonte says helps them consider whether they might suffer from undue stress because they’re not focusing on what’s truly important to them. They also learn to consider how daily stresses and triggers are affecting their lives, and they practice yoga and tai-chi.

“By the end of the month, they almost always feel better themselves,” said Chiaramonte. “They really learn viscerally for themselves that this stuff works.”

The Maryland students aren’t the only ones looking past the pill in search of better health. A growing number of Americans have embraced complementary or integrative medicine, which combines conventional, allopathic medicine with alternative therapies.

According to the most recent data from the National Institute of Health’s National Institute for Complementary and Alternative Medicine, some 38 percent of Americans used some form of alternative medicine in 2007 — up from 36 percent in 2002. [ This was five years ago!  I’ll bet that percent is much more than 36 by now.] Experts say such figures explain why a growing number of medical schools have embraced what critics deride as “woo-medicine,” but proponents of the techniques say integrative medicine represents the future of health care.

“More and more students are interested in integrative medicine — that’s clear,” said Dr. Mary P. Guerrera, a professor of family medicine and director of integrative medicine at the University of Connecticut. “There is greater awareness in the world-at-large. With that, students are coming to medical school already aware of what it is.”

In the last decade, the National Consortium of Academic Health Centers for Integrative Medicine, which was formed to promote and support integrative medicine in medical schools, has ballooned from eight member institutions to 51. That list includes top academic names, like Harvard University, Johns Hopkins and the Mayo Clinic.

Last month, University of California-Los Angeles hosted the first-ever National Student Conference on Integrative Medicine, an event created by students looking to build upon the traditional medical school curriculum by exploring topics from what they dubbed an “integrative perspective.” It drew more than 100 attendees, including some who don’t have access to training in integrative medicine at their home institutions.

“I met a resident who wanted to incorporate some of these practices and who said it was so helpful to have physicians who he could talk to. … It gave him hope that he can go out there and learn this,” Guerrera said. “He felt very isolated in his training program, because there was no one he was able to identify to help him.”

Among the institutions that do provide training in integrative medicine, that education takes many forms. Some medical schools offer month-long immersive electives, others simply offer several-hour-long lectures introducing medical students to areas they may not have considered before.

The University of Arizona [not all that far from Bisbee, folks]  has been at the forefront of incorporating integrative medicine into its programs: They’ve partnered up with like-minded residency programs and recently created a distinct program for medical students that lets them supplement their traditional training with a focus in integrative medicine over their four years.

“It’s a really big step that the College Of Medicine was willing to say ‘This is important. This is no longer fad, and we will recognize it,’ ” said Dr. Victoria Maizes, executive director at the Arizona Center for Integrative Medicine.

But some medical schools still lack a formal environment to learn integrative medicine, experts say, and not all institutions have faculty that’s supportive of the techniques. That may in part stem from limited evidence testifying to the efficacy of alternative therapies. Even the National Institute for Complementary and Alternative Medicine acknowledges many complementary and alternative medicines lack the backing of trustworthy clinical trials.

But Maizes argued that many tenets of complementary medicine have already been independently verified. She noted, for instance, that there is significant scientific evidence supporting the role of good nutrition — which is a major focus of integrative medicine — in health, as well as the connection between the mind and body. What is lacking, she said, are clinical trials comparing integrative therapies to traditional medicine.

Which is why supporters believe incorporating integrative medicine in medical schools is important, so that students who apply integrative therapies and ideas are well-grounded in conventional training.

“We’re not cutting anything out from traditional medicine,” Chiaramonte said. “We’re adding to the toolbox.”

You can find the article at: http://www.huffingtonpost.com/2011/11/15/integrative-medicine-medical-schools_n_1093279.html

Remember I ran off last week to go meet my buddy?  I made that comment after writing about how I only wanted to be with people who wanted to be with me.  I’m closing with a picture of that meeting so you can see how being with people who want to be with you (that you want to be with) can be such a happy experience for the two of you.  I really missed you Joan Diamond!

Being with people who want to be with you (that you want to be with, too) can retard the progression of your CKD… or at least make it more pleasant.

Until next week,

Keep living your life!