clinical trials

From preclinical to approval: How clinical trials bring new treatments to market

Often we hear of new treatments becoming available, but have you ever wondered what each new treatment had to go through to get approved by a regulatory body like the FDA? Before a new treatment is approved for commercialization, it needs to go through a meticulous trial process to prove a number of things: Is the drug safe? What are the potential side effects? Does the drug do what it’s supposed to do? All of these questions and more need to be answered before a drug can be considered for approval by the FDA, so that’s where clinical trials come in. Here’s a breakdown of what’s involved in the drug development process, from preclinical through to commercialization and post-approval monitoring. (Click to enlarge) How can I participate in a clinical trial or find out more? You can learn more about research and clinical trials by joining or logging into PatientsLikeMe and clicking on the Research tab Use the PatientsLikeMe Clinical Trial Finder to search for trials that could be a good fit for you Check in with local associations and hospitals to see if they are recruiting for any trials Talk to your healthcare provider/clinician to see if there are opportunities …

From preclinical to approval: How clinical trials bring new treatments to market Read More »

It’s Clinical Trials Day, and patients are driving change

Today is Clinical Trials Day – celebrated to bring more attention to public health and also to recognize the contribution of the patients and healthcare professionals who make clinical research possible. At PatientsLikeMe, it’s members who are changing the way clinical trials are designed. Bringing the patient voice to clinical trials has long been part of the PatientsLikeMe mission. Jeremy Gilbert, Vice President, PLM Health and Paul Wicks, Ph.D., Vice President, Innovation, sat down with us last year to talk about the importance of putting patients at the center of drug discovery and development. Check out their Q&A here. Recently, Paul Wicks touched on the purpose behind the latest PatientsLikeMe study on clinical trial design involving the patient perspective, and why organizations need to work on improving their trial process: “As researchers we know that clinical trials are the best tool we have for identifying new, safe, effective treatments. Patients know this, too, and they’re motivated to take part. But what this research tells us is that actually participating in a trial is not a fun experience; about as much fun as dealing with the worst airlines, banks, or utility companies, and we all know how that can be. This …

It’s Clinical Trials Day, and patients are driving change Read More »

The record on research: Catching up with TOA member Cris

Back in January we introduced Cris, a member of the 2016-2017 PatientsLikeMe Team of Advisors living with ALS. She’s also a fierce patient advocate who’s participated in several clinical trials since her diagnosis. We recently caught up with her to learn about her experience with clinical trials and why access and awareness of clinical trials is so important. Despite her shy personality, Cris got involved with patient advocacy with the encouragement of her ALS specialist, Dr. Richard Bedlack. Determined to overcome her shyness, Cris found motivation and purpose in advocating for future patients, family and friends and the belief that access to all trials should be easily available for a patient and not complicated to locate. In May, she attended the ALS Advocacy Day in Washington D.C., where she represented pALS from North Carolina and shared her own ALS journey with her state’s senators. Cris believes that clinical trials are critical for survival, present and future, but physicians don’t know about, or take the time to discuss current trials with patients unless their facility is active in research. There are very few active ALS clinical trials and because of stringent trial protocols, many patients are not accepted due to progression …

The record on research: Catching up with TOA member Cris Read More »

The power of your data: Improving clinical trials

For these 24 Days of Giving, we’re rethinking what it means to give and how the power of patient data can change healthcare for the better. Another example of the impact your data can have? Making the clinical trial experience better for patients like you. Now let’s be real, that’s no short order. So where do we even start? With you, and every new member who joins the community. Every day, members are sharing their thoughts on trials, what would make them most likely to take part, and what would turn them off. It’s an ongoing research experience, but let’s take a look at snippet of results so far: 4,718 members have taken part so far… How do you learn about clinical trials? 59% learned about a trial from your health team, 24% via the web. 24% of you said you first thought of participating in a trial without suggestion from anyone else. For those who participated in past trials, the first person to suggest that you participate in a trial was a doctor (43%) or another healthcare provider (19%). Those of you who took part in clinical trials decided to because of your own desire (80%). Key takeaway: Most people …

The power of your data: Improving clinical trials Read More »

PatientsLikeMe Launches Virtual Trial for ALS Patients

Study With Major Academic Medical Center to Evaluate the Potential of the Soy Peptide Lunasin to Reverse ALS Symptoms DURHAM, N.C., October 25, 2016—PatientsLikeMe and The Duke ALS Clinic have just completed enrollment in a virtual trial designed to test whether Lunasin, a peptide found in soy and some cereal grains, is helpful or harmful to patients living with amyotrophic lateral sclerosis (ALS). The Lunasin Virtual Trial is the first study of the supplement in ALS patients and follows a review analyzing its potential to reverse ALS in ALSUntangled, a website for clinicians, patients and researchers to explore alternative treatments. Duke ALS Clinic Director and ALSUntangled Founder Richard Bedlack, MD, said he first heard about Lunasin’s potential from Mike McDuff, an ALS patient who took the supplement and experienced dramatic improvements in speech, swallowing and limb strength. “I reviewed Mike’s records and reports, and both his diagnosis and his improvements appeared real,” Bedlack said. “Of course, Mike might have an ALS mimic we don’t know how to test for, or his body may have found a way to beat ALS independent of treatment. But there is one more possibility: his Lunasin regimen might have actually worked. I was compelled to …

PatientsLikeMe Launches Virtual Trial for ALS Patients Read More »

Bringing the patient voice to clinical trials

PatientsLikeMe has a long tradition of bringing the patient voice into drug discovery and development, but it’s only been in the last year or two that industry has been tuning in to hear what that voice is saying about clinical trials. For the last 18 months, we’ve been asking many of our members about their attitudes toward and experiences with clinical trials, and working to ensure pharmaceutical companies understand what patients want most from trials, now and in the future. We talked with Jeremy Gilbert, Vice President of PLM Health, and Paul Wicks, Vice President of Innovation, about what we’ve found, and how that’s already helped to change the design and execution of trials and their future direction. Jeremy will be presenting more about this topic and details of a key project with AstraZeneca and Takeda that leverages the patient voice in new ways at the Patient-Centered Clinical Trials Conference in Philadelphia on October 11. More info about discounted tickets below.   You’ve surveyed more than 1,400 people about their experiences and opinions with clinical trials. What have they shared, and what has PatientsLikeMe done with that information? Jeremy: A lot of people in our community are living with life-altering, degenerative …

Bringing the patient voice to clinical trials Read More »

14 questions to ask before you enroll in a clinical trial

Have you ever participated in a clinical trial? How much did you know going into it? Our partners over at the Center for Information and Study on Clinical Research Participation (CISCRP) came up with a whole list of questions that will help you decide if a clinical trial is right for you before you commit. Here are a few of them below, but you can check out the full list and a printable version here.   Got any questions you’d add to this list? Head over to the forum and share them with the community!   Share this post on Twitter and help spread the word.

Patients as Partners: John and David share their clinical trial experiences

We’ve been hearing from members of the Team of Advisors about how they’ve used the Partnership Principles in their health journeys. Recently, we sat down with John (Dockstoy), living with ALS, and David (Davidgewirtz), who’s living with lung cancer. John and David are both interested in research and have been involved in a few clinical trials. Below, they share their firsthand trial experiences, offer up some advice for others, and talk about the importance of collaboration and mutual respect with their care teams along the way. Can you tell us a little about the clinical trials you’ve participated in? John: I took part in trials at: Massachusetts General Hospital (September 2014) – phase 2, randomized, double-blind placebo-controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS Bronx VA – Brain and nerve stimulation for hand muscles in spinal cord injury and ALS Weill Medical College of Cornell University – Safety of Capryclic Triglycerides in ALS: A Pilot Study David: I was diagnosed with stage four metastatic lung cancer just about five years ago. June 2011. Since that time my only form of treatment has been targeted therapies which were available to me through clinical trials. The first clinical trial I received …

Patients as Partners: John and David share their clinical trial experiences Read More »

A patient’s perspective: member Gary reports back from the FDA public meeting on Parkinson’s disease

Back in September, Sally Okun, Vice President of Advocacy, Policy and Patient Safety, and community moderator Molly Cotter, attended the FDA public meeting on Parkinson’s disease (PD) along with PatientsLikeMe member Gary (tupelo). We posted some interesting developments from the meeting in the forum, but we also caught up with Gary for his perspective on the event. Here’s what he had to say: Why did you want to be part of the FDA public meeting? On the day I was diagnosed, back in 2012, I spent a great deal of time reflecting on my life. I thought a lot about how Parkinson’s disease will impact me and my family in the future. On that day I made a commitment to myself that I was going to take control, to the best of my ability, on the course of the disease progression, and would do anything possible to find a cure. I was determined to educate myself as much as possible about the disease, put together the best possible health care team, learn all I could about treatments currently in research, and participate in clinical trials. Parkinson’s was a new challenge in my life and I intended to tackle it like …

A patient’s perspective: member Gary reports back from the FDA public meeting on Parkinson’s disease Read More »

Subjects no more: what happens when trial participants realize they hold the power in clinical trials?

When I first became involved with online communities back in 2002, I moderated a small forum for patients with ALS/MND in the UK at King’s College Hospital to connect with one another, share tips and support, and to help our care center to serve them better. One area that remains controversial even to this day is clinical trials. ALS is a rapidly fatal and incurable illness, and as a young researcher I was often trying to field questions that patients had about the trials process: “Why aren’t there more trials taking place?” “Why do we have to have a placebo?” “If researchers think commonly available treatments like dietary supplements or antibiotics might slow my disease, why can’t I just take them anyway rather than being enrolled in a trial?” Given the severity of their situation and the slow pace of clinical trials (it’s estimated that it takes over 10 years for a new discovery to go from the lab to the clinic), I certainly sympathized with their frustrations and did my best to get the answers they needed, asking my medical colleagues where I could and translating the technical jargon. A few patients decided to go a step further than …

Subjects no more: what happens when trial participants realize they hold the power in clinical trials? Read More »

Scroll to Top