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From Public Relations Executive to Chronic Pain Patient

One inspiring patient shares an important message: YOU are your own best advocate

Every once in a while, we hear a patient story that gets to the heart of why we do what we do, that reminds us why we are working every day to help patients find and take part in clinical trials. Linda VandeVrede has one of those stories.

She’s a former high-tech PR executive who is anxiously awaiting medical advances that may offer some relief from her chronic pain. Linda’s been a supporter of TrialReach since she found us through social media – she believes that in the medical community, self-advocacy is key. So how did a thriving career woman become a patient advocate and one of the loudest voices for chronic pain research?

Photo by Michael Ging Photography

Photo by Michael Ging Photography

Linda’s pain started during flights to and from Europe. The pain would kick in, but it would subside when she landed and she’d forget about until the next flight. The tech world was booming, and Linda didn’t have time to dwell on the pain. She didn’t have time, that is, until 2007, when she felt an incredible jolt of pain in her right leg, unlike anything she’d felt before. She left work and went to her doctor’s office immediately. X-rays revealed no issues, and Linda’s quest to figure out her medical condition began.

The next five years were devoted to finding an answer. Linda was forced to give up the career she loved because she could not tolerate sitting or standing in front of a computer for any real length of time. She tried everything, from neurologists to acupuncturists, from cranial sacral therapy to physiatrists. No one could provide any answers, or even any relief. She began to think that doctors didn’t want to see her: “after awhile, you get the sense that because doctors can’t find anything, either they don’t believe you’re really in pain or they just want to move on to someone they can help.” To add insult to injury, Linda is someone whose body cannot tolerate opiates – they either have no effect or she winds up in the emergency room.

Desperately searching online for answers, Linda came across an online forum of people with the same symptoms she had. In talking to members of this forum, she found her answer: Piriformis Syndrome, a condition in which the piriformis muscle constantly suppresses the sciatic nerve. It’s very uncommon, and is typically caused by either repetitive or sudden trauma. Online research uncovered a paper on the condition that sounded like it could have been written about Linda. She reached out to the surgeon who had written the paper, and when she went to see him, he instantly knew how to trigger her pain. Thrilled that she had found someone who finally “got it,” Linda agreed to an invasive surgery, where the doctor released tension from her nerve but found irreparable damage to her sciatic nerve. While she found some relief from the surgery, if she had had this procedure ten years earlier, the results would have been different.

Unable to find relief surgically or medically, Linda lives in a constant state of pain. She speaks out against sensationalist media stories about drug-addicted pain patients, and is anxiously awaiting trials for a new class of medication called a sodium channel modulators.  While she considers herself well-educated on chronic pain and her treatment options, she continues to find “ so incredibly frustrating.” She says the multitude of names for chronic pain makes her condition terribly difficult to research, and can’t wait for TrialReach to take on chronic pain to structure eligibility and remove the guesswork from trial searching. We assured her it’s on our list! While she waits, Linda is shouting from the rooftops about the importance of research in this field, and building a large network through social media that allows her to connect with some of the 100 million other people who experience chronic pain. She says, “when you have pain, you’re not likely to get out there and advocate for yourself. It’s disabling, but people can’t tell you have a disability. You can spiral. I try to stay positive for me, and for everyone else.”

Linda’s message to other patients is to realize early on that you are your own best advocate – educate yourself, and don’t be afraid to take the lead in doctor’s appointments. While the doctor is an expert in medicine, you are the expert on you and how you are feeling. We couldn’t have said it better ourselves. Linda, you’re an inspiration to all patients – especially those unsatisfied with current treatment options. Thank you for taking the time to share your story with us!

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An ADA Scientific Sessions Top Ten

We’ve been hard at work perfecting our new diabetes clinical trials smart search tool, and have finally had some time to reflect on the incredible experience we had at the American Diabetes Association Scientific Sessions last month. We were blown away by the research presented, the connections we made, and the dedication we saw to improving the lives of those living with diabetes.

Since we’re already missing David Letterman, we’d like to share an ADA top ten. Here are the top ten things we found remarkable about ADA:

  • The ADA’s new CEO, Kevin Hagan, was fantastic at the conference. We’ve rarely seen a chief executive be so approachable and responsive. We so appreciate that when we reached out, he got back to us in minutes. We look forward to continuing to see him lead by example.
  • We had the pleasure of screening the PBS documentary Journey to a Miracle: Freedom from Insulin, an amazing story of how researchers all over the world came together to find the genetic mechanism for monogenic diabetes, a type of diabetes caused by a mutation in a single gene. It’s estimated that about half a million people fall into this category and may unnecessarily be receiving insulin. What a wonderful example of what can happen when patients and researchers come together with a shared goal.
  • The level of online engagement we saw around ADA was phenomenal. The hashtag #2015ADA reached about 50 million people, and the engagement levels were impressive. We loved hearing from our friends at Diabetes News, Diabetes Mine, and Diatribe News, and were especially impressed by the advocates who came out en masse to share news from the conference. Special shout out to some frequent tweeters: @insulinnation, @KellyRawlings, @joyclee, and @CureT1Diabetes.
  • The ADA crowd-sourced inspiration through a board on which attendees could write what they’re hopeful for in the future of diabetes care and management. We saw some great suggestions, like oral insulin, better screening and diagnosis, and beta cell regeneration. We’re so glad to see this community thinking big and aiming high!
  • We attended a presentation from Amy Tenderich of Diabetes Mine about the role of social media in diabetes. Amy pointed out that the diabetes online community is a great place to connect, share, commiserate, motivate, and spread awareness. We couldn’t agree more, and will be watching out for more research on the relationship between online patient engagement and health outcomes.
  • The packed house at the Afrezza inhalable insulin product education session was a sign of how excited the community is about this new method of treatment. Hopes are high that the fact that Afrezza mimics the way the body uses insulin will allow for more effective blood sugar control – and that replacing injectables will improve daily life for those living with diabetes. The promise of this product motivates us to keep helping drive more and better diabetes research.
  • We loved seeing David Marrero, the ADA’s President of Health Care and Education, on stage declaring that, “we must address diabetes from the patient point of view.” What a powerful message to share with this those of us attending ADA, and beyond. We were thrilled to see patients being elevated at ADA.
  • At the #wearenotwaiting data event, we heard from companies like Tidepool and Livongo Health, who are transforming diabetes care by facilitating data sharing. We believe these companies are well on their way to addressing the innovation bottleneck that spurred the #wearenotwaiting movement.
  • On the topic of #wearenotwaiting, we were also inspired by the individuals advocating for change in diabetes research. The advocates onsite were loud, proud, and easy to cheer on. One of our favorites was Anna McCollister-Slipp, the cofounder of Galileo Analytics, who spoke eloquently on the need for change in the way we treat data around diabetes research.
  • Lastly, kudos to the ADA for one of the most phenomenally well-organized events we’ve ever attended. The organization hosted 18,000 attendees and each session, presentation, and discussion was given full attention and run incredibly smoothly. Thanks for making this conference a pleasure to attend!

We’re already looking forward to attending next year. In the meantime, if you’re interested in diabetes research and patient empowerment, stay tuned for news on our new simple search tool that uses cutting-edge technology to scan all open diabetes trials in the US and generate personalized, easy-to-understand clinical trial options.


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What You Need to Know About Genomics

TrialReach’s very own Sarah Kerruish will be participating in a Google+ hangout tomorrow focused on how industry partners can all work together to increase patient engagement in genomics testing. The panel, which includes heavy hitters from Genentech, Washington University, N-of-One, and Expression Analysis, a Q2 Solutions Quintiles Quest Joint Venture Company, will discuss how genomics testing can be better incorporated into clinical research, and how to talk to patients about this type of testing. We invite you to weigh in and ask questions – RSVP for the event here.

The topic is a complex one, but because we know that patient points of view are critical, we’ve outlined a few basics we think you need to know about genomic testing ahead of tomorrow’s event.

  • Precision medicine is an approach to disease prevention and treatment that takes genetic differences into account. It is based on the fact that humans are not all the same, so one-size-fits-all treatment options are often not the most effective choice.
  • Thanks to recent scientific and technological advances, doctors can take a close look at your genetic makeup to help determine what mutations may have led to a particular illness.
  • Mutations may be either inherited, meaning you were born with them, or acquired, meaning lifestyle or environment caused a gene to change. For example, lung cancer is often caused by smoking because cancer-causing chemicals in cigarette smoke cause genes to mutate. But, lung cancer can also occur in non-smokers, and in those instances, family history may be implicated.
  • The fact that doctors can identify which mutations are causing a certain illness through genomics testing is crucial as new treatments are being developed that can target specific mutations. This means, for example, that if a mutation is causing cells to divide uncontrollably, a drug targeting that mutation can suppress cell division and slow the growth of a tumor.
  • This type of genomic testing is beginning to come into play in clinical trials, as researchers test new drugs targeted at specific mutations. Clinical trials testing these targeted therapies will exclude patients without the specific mutation, so it is important that patients educate themselves on the specifics on the gene-related details of their disease. If you’ve had testing, your doctor should be able to give you these specifics, and there are a multitude of resources available online to find out more. For example, the American Cancer society has a great primer on genomic testing and cancer.
  • Genomic testing can also be used to help determine the likelihood that you will develop certain diseases during your lifetime. For example, a doctor may be able to tell you if you have a genetic mutation that commonly causes breast cancer, and estimate the chances you’ll get it later in life.
  • What you do with the knowledge that you have a mutation is up to you; some people choose to have preventive procedures, while others practice watchful waiting and regular check-ins with their doctors. For example, some women who discover that they have a mutation that will likely cause breast cancer will choose to have a mastectomy, while others will undergo more frequent mammograms.
  • All genomic tests are voluntary, and you should make sure you discuss the benefits and the risks with your doctor prior to testing.

Now, we want to hear from you! Please feel free to post any questions or comments to that hangout page or on Twitter using #genomicknowhow. Sarah and the rest of the panel will be happy to answer them on Tuesday.

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On International Clinical Trials Day, a look at where we’ve been – and where we need to go

Two hundred sixty-eight years ago, the sailors aboard the HMS Salisbury were facing a very real fear: scurvy, a disease that had claimed the lives of more than a million sailors, had appeared on their ship. It was thought that perhaps drinking orange and lemon juice might prevent the disease, but no one knew for sure how to stop the life-threatening illness.

patient-globe@2xEnter James Lind, a surgeon in Britain’s Royal Navy who is known today as the first to run a clinical trial. Lind, “acting on a hunch that scurvy was caused by putrefaction of the body that could be cured through the introduction of acids,” recruited twelve sailors to participate in what is widely believed to be the first “like versus like” comparison test of treatment options. Lind gave two men each a different treatment regimen every day for two weeks, and in the end, those given citrus fruits had the best response. The key to curing scurvy was discovered – and the clinical trial as we know it was born.

Centuries later, we’ve come a long way. Today, the US government website lists 35,373 clinical trials actively recruiting patients. In the years since Lind’s time, clinical trial protocol and drug approval practices have become heavily regulated, and hundreds of thousands of clinical trials have yielded some 1,505 FDA drug approvals to date. These drugs provide relief from symptoms and – in some cases – save lives.

picToday, we are celebrating International Clinical Trials Day. If you are a patient who has participated in a trial, or a researcher who has conducted one, thank you. Your involvement in clinical trials is crucial to providing hope for the future of medicine.

But, we know that there is still work to be done. Just 3% of American cancer patients participate in clinical trials, and only 15% are even aware that clinical trials are an option. This may be one reason that up to 40% of oncology trial sites fail to enroll the minimum number of patients needed to conduct the trial. Time is wasted, money is wasted, and patients continue to suffer through illnesses without knowing all of their options.

We can do better. James Lind got the ball rolling. Let’s keep it going.


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The Lilly Clinical Open Innovation API and TrialReach: A Story of Innovation

This blog post was written by Tom Krohn, Chief Development Officer at TrialReach

Everyone has a story.  You.  Me.  Innovation.

About four years ago, a small group of Lilly employees started work on open innovation with a focus on improving public information to accelerate medical innovation. Barry Crist and I wrote a whitepaper that outlined a vision for clinical knowledge generation becoming participatory for all in the clinical research ecosystem, especially patients.  Participatory—that is the essence of an open network. It is at the core of open innovation.

With executive sponsorship and a case for action, we took these ideas and developed an open API, which launched in 2012. We put Creative Commons copyleft licensing on the API to remove the friction that is the norm of the life science industry. Then, open innovation happened.

People started using the API. Patient organizations. Data service providers. Even our competitors. We ran an in-house hackathon that generated some cool apps, a codeathon with central Indiana talent, and a Clinical Trial Redesign challenge. We learned and evolved with the emerging marketplace. But the data was insufficient. While the API made things easier, an API is only as good as its content.

We shifted our focus and did the hard thing: listening to patients and those serving patients. We challenged all of Lilly to listen and engage patients differently: in trial design processes, in trial execution, and through post-study results sharing and continuity of care. Our Patients at the Center of Clinical Trials Workshop was a powerful onsite gathering of open sharing and creative solutions with patients and disease advocacy leaders (the first of its kind for Lilly, and perhaps all of pharma). One of the areas in which patients spoke very loudly was helping patients find, understand, and match to clinical trials. receives 112 million page views per month. A good portion of those views come from patients and their caregivers, yet it is far from meeting patients’ needs.

This was a challenge we had to take on.

Patients 2 Trials

We in the pharma industry are our worst enemies, because we make it difficult for patients to connect to our studies. Information is hard to find, is written from a scientific-only point-of-view, and is often only available at the investigator site where distance and logistics can be a big barrier to patients.  We also focus on our single study while from a patient point-of-view, the perspective is “which clinical trial might help me?” regardless of the sponsor. With this background and understanding, we moved this initiative beyond Lilly to a small consortium of the willing. This was the birth of the Patients 2 Trials Consortium.

Using our API as a base platform for augmented content, we took on the task of structuring eligibility criteria in a consistent and machine readable manner. Pfizer and Novartis, through their innovation teams, recognized the potential and joined us. Soon we were structuring trials from each of the consortium’s partners. At the same time, the U.S. government had put the Blue Button initiative into play with Meaningful Use stages and incentives, and we now had a patient record format against which to test our approach. We successfully tested it and shared the outcome at the 2014 Partnerships in Clinical Trials conference.  The Patients 2 Trials consortium then moved on to market pilots and finding a long-term home for the API and the trial matching approach. The primary goal of finding a long-term home was to maximize impact for patients, drive to sustainable scale, and ultimately to help transform the industry.


Lilly chose TrialReach to be the long-term home for its API platform and trial matching work, and completed the agreement late last year.  TrialReach’s strong patient focus, large network of partners and freemium business model made it a great home for the initiative. Lilly and TrialReach completed the technical transfer of the API in the first quarter of this year. And, at the 2015 Partnerships in Clinical Trials, representatives from Lilly, Pfizer and Novartis announced the transfer of leadership to TrialReach.

So what is next?  First of all, three of the Lilly COI team members (Tyler Trueg, Dean Sellis and me) have chosen to join TrialReach to see this innovation through to full success. It was a tough decision for each of us. We truly enjoyed the innovation work at Lilly and the collegial environment that allowed us to make a difference. We are excited to bring our knowledge and experience in clinical trials and the API platform and combine them with the patient-engagement insights of the TrialReach team to help this become an industry game changer.

TrialReach is committed to structuring ALL recruiting clinical trials and making this information ubiquitous on the internet.  We’ve started with diabetes studies and have a plan in place to roll out additional therapeutic areas. Our goal is to complete all therapeutic areas in one year.  It is a big goal, but also one for which patients are waiting.

We are also committed to partnering with sponsors in bringing easier-to-understand study information to the internet.  As I’ve shared before, we need to separate informed from consent.  Patients need to be informed to consent, but don’t need to consent (at site) to be informed. Instead, patients need and deserve clear information so they can compare studies, determine which ones they may be eligible for, and deeply understand the implications of participation in a study—all before they have to make the journey to the nearest investigator site for the full screening and participation.

Time for Change

The time for this change is now. The industry needs to look at its trial accrual challenge through new lenses.  Patients have wanted this improvement for a long time. And, it is personal to us and to me. About two years ago, I lost my brother-in-law to esophageal cancer. Unfortunately, by the time a clinical trial was considered, it was too late. As my sister-in-law said, “I believe most patients who want to fight their cancer will be very interested in clinical trials if they could find them and understand them and didn’t have to depend solely on our doctor.” This is exactly what we are trying to do.

And so the story continues, both my story and this innovation story.  I’m not sure how the story ends— we never quite know. But we’ve made it this far through perseverance and commitment. I know we’ll be faithful to patients and the vision to serve them well.  And in the process, write another chapter in the innovation book and changing the life science industry.

About the Author

Tom Krohn is the Chief Development Officer for TrialReach and is responsible for business development, including clinical trial sponsor tomrelationships, patient advocacy groups, and research institutions. He has 25 years of experience across different sectors in health including large pharma, hospital & retail pharmacy, and the developing world. Most recently, Tom led the Clinical Open Innovation team at Eli Lilly with a focus on patient engagement, open data, and business transformation. Tom is passionate about serving patients from their point-of-view while building sustainable and highly effective organizations.

This blog post originally appeared here. It’s been reprinted with permission.

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Are you eligible? #BreastCancer Trial Needs #MBC Patients. Written by AnnMarie Ciccarella

There is a breast cancer trial that is recruiting right now for a new targeted therapy. You may be eligible to participate or you may know someone who is eligible. We all benefit from this so I’m asking this be shared in as many places as possible, especially in groups where there is a large population of people with advanced or metastatic breast cancer.

Afraid of participating in a clinical trial. Worried about that lab rat thing? Please click over to this post for a basic rundown. I’ll just say this. When anything other than cells in a dish are involved, protection of humans and animals is taken quite seriously. There are rules in place for the real rats. Seriously.

Do you fit the profile for this trial? Here’s the checklist:

  • Are you post-menopausal? It doesn’t matter if it happened naturally, surgically or through ovarian suppression.
  • Has your cancer spread outside of your breast?
  • Is your cancer ER+ or PR+ (either one will do)?
  • HER2 negative?
  • Have you done only one line of endocrine treatment since the disease metastasized? In English, did you take tamoxifen or femara or arimidex and only one!

All yes responses to that group? Let’s continue. (Yes responses to these questions will likely result in being ineligible.)

  • Have you been treated with chemotherapy since your metastasis? If so, you may not be eligible but definitely check with the researchers.
  •  Have you already been treated with fulvestrant (Faslodex) or everolimus (Afinitor)? If so, unfortunately, you will not be eligible for this particular trial.
  • Has your cancer spread to your central nervous system (i.e. brain mets)?
  • Do you have inflammatory breast cancer?
  • Inflammatory breast cancer patients or those whose disease has metastasized to the central nervous system, this trial isn’t for you. We’ll find others.

There are obviously many other items that will determine inclusion/exclusion but those are the ones that jumped off the page for me.

A little about the trial and what to expect:

  • The length of time for participation is 36 weeks.
  • You will need to be at the test site for approximately 15 visits. This is a multi-center trial. A list of locations is included in the eligibility link below.
  • In the beginning the visits will be frequent and then taper off.
  • There is no cost to you to obtain the drug or any of the testing.
  • Travel may be reimbursed.
  • You will be randomly assigned to receive the real medication or a placebo.
  • All participants will be treated with fulvestrant which is currently one of the standards of care for metastatic disease. My mom is already on fulvestrant but was ready to step right up until I told her she wasn’t eligible.
  • The purpose of this trial is to determine if combination therapy of the fulvestrant and the investigational drug is better than fulvestrant alone.
  • THIS IS THE MOST IMPORTANT PART OF THE POST: You can read more about the study on Trial Reach where there is a link to the complete study information on

Why do this? You may be helping yourself. And who knows, this might be the next big thing and you may be part of something that help us finally turn a corner. I’ve participated in a number of trials and I wouldn’t hesitate to join another. I hope you feel the same way. Without us, there will be no advances. Having a trial not meet accrual goals in an expeditious fashion is a waste of precious resources. Closing promising trials because goals are not met is a story for another day. But, it does, indeed happen. And the reason?

Primarily because we simply don’t know we are needed.

Now, you know.

Please do share this! It’s important. Lives depend on it.

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AnnMarie Ciccarella: On the Importance of Clinical Trials

Clinical trials save lives.

Research is where the answers lie.

Without research, there are no clinical trials.

Without clinical trials, people do and will continue to die.

Without people, trials can not take place.

So the real question is this. Have you stepped up?

Too many people equate participation in clinical trials with being a lab rat. Let’s take a moment to dispel some myths or clarify some facts. First the basics.

The very first basic simple truth: Navigating can be extremely frustrating, even to the most seasoned doctors. Since the very first step is knowing where to look for these things, there are platforms out there to help make the process easier. Social media is changing the way researchers and participants connect. We should be doing this faster, better and more efficiently.

Now some background and general facts.

Clinical trails must adhere to the highest standards to protect trial participants. There are laws in place to ensure the risk associated with any research is no greater than the normal risks inherent in every day living.

When you make a choice to participate in a clinical trial, first and foremost, you will always receive the best evidence-based medical care currently approved and being used to treat the condition or disease being studied.

With those two things in mind, yes, there are risks associated with clinical trials but any new medication that is granted approval to proceed to human testing has already undergone rigorous studies in a petrie dish, on a lab slide and generally, in animal studies. Only after the safety has been established throughout that process, can a drug proceed to trials using real people. Human clinical trials run in phases, too. For this conversation, let’s focus on the last leg of the human trials, the Phase III trial.

By the time a drug is approved for phase III trials, the researchers have already determined its safety, identified most of the short term side effects and it’s already shown the new drug or drug combination may be more beneficial than the current standard of care. And that’s the biggest and most important reason to consider joining a trial for which you may be eligible.

I wish that I had paid more attention to this when I was diagnosed with invasive breast cancer. I know there are trials I would have sought to join. The thing is, the guidelines are set in stone and if you choose a treatment before knowing all of the available options, you can’t unring the bell. You may have excluded yourself from being among the first to gain access to a drug that could take years to become available to the rest of us. The process from trial to results to publication to approval is long.

Few of us are told to look at clinical trials as our best first choice for treatment and when we are diagnosed with a serious disease like cancer, the knee jerk reaction? Get.It.Out. Preferably yesterday. For those whose disease has spread, the sense of urgency takes an exponential leap. And this is the moment to stop. Breathe. Explore every option. And then make a decision.

To paraphrase my friend, Jack Whelan, why settle for standard of care when participating in research may actually be a better course of treatment?


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