So sorry for the silence! I’ve been working on many topics and issues, and you will hear about them soon. I also forgot to share this guest blog post I did back in March 2017.
The Clinical Trials Arena post, Trial Results Create a Win for Patients and Companies, covers the reasons trial summaries need to make sense to real people. Health literacy is different than reading literacy and frankly, even people with MDs and PhDs (& other alphabet parts) behind their names have trouble understanding complex clinical trial information!
This post was an update to some my other posts, including:
Since that time, the European Medicines Agency (EMA) has finalized their Summaries of Clinical Trial Results for Laypersons recommendations. Unfortunately, there is still no final date on when public summaries must be posted on their website – it’s beginning to look like early 2019.
An article called Layperson Summary in the EU explains some of the history involved. By the way, PLEEEZ do NOT use the term “layperson” when referring to public research summaries! It is a ghastly term to use when you want to engage patients, and the Webster dictionary does not include “non-scientist” in any of its 14 definitions for the word “lay.” Truly, it sets up an elitist barrier that absolutely negates the intent of this initiative.
I am also now helping Health Literacy Media (HLM) develop their services for clinical trial sponsors. More on that soon – a new website is coming and will be announced!
Watch for updates about this and other initiatives related to sharing clinical trial results with patients and the public. It’s high time, and we’re all learning how to do this together!
Great news for those confused about Ductal Carcinoma In Situ (DCIS). That includes just about everyone, from doctors and researchers, to patients and their families!
Four new projects and resources are available:
- A new study called COMET just opened that will look at whether women with low-risk DCIS will do just as well with active monitoring (also called Active Surveillance) as those who choose surgery, radiation and/or hormonal therapy. Watch the video.
“The aim of this work is not to try and determine what’s ‘better,’ but rather to quantify the tradeoffs associated with these two approaches to DCIS treatment.”
– Dr. Shelley Hwang, Principal Investigator
- A new website for DCIS also opened this week to help the over 50,000 women per year who are diagnosed with DCIS each year in the U.S. Of course, the site is also available for women worldwide.
- SHARE is sponsoring a webinar called “DCIS: What You Need to Know” that features
yours truly on March 22 at noon Eastern Time (US). We’ll explain what DCIS is, how to think about it, and what is needed to make rational decisions when faced with a diagnosis.
- A new international research project called “Preventing Unnecessary Breast Cancer Treatment” was recently announced to learn how to find DCIS that will not turn into breast cancer so women won’t have to deal with treatment issues.
Together, these projects can tell us how to deal with DCIS, what risk factors may cause approximately 1 in 10 women to develop a later invasive breast cancer, and hopefully, that Active Surveillance works just as well as invasive treatments.
By the way, about 90% of women with DCIS won’t get invasive breast cancer!
If you can’t wait to find out more about DCIS, check out this post or get the DCIS Dilemmas ebook. Stay tuned for more about these projects and other findings about DCIS!
Some members of the COMET Study team
Due to popular demand, former blog guests Bruce Bloom, and Clare Thibodeaux from Cures Within Reach have returned with another post. This time, they explain how they bring researchers, older drugs, and new funders together to come up with new solutions for patients. Disclosure: I am a member of their Advisory Board, and think this concept is brilliant!
Here is a guest post I wrote earlier this year for METAvivor called “How Do People Feel about Bone Marrow Exams?” It was based on a study with Bonnie King from Stanford. While this may be one of the more gruesome-sounding medical procedures that some patients go through, it is not necessarily unique.
Too often, researchers think about all of the cool data they can collect during a clinical trial or research study, without thinking about what is would be like to experience all of those test procedures. Well, patients think about it, and often wonder what is wrong with the researchers!
I’m always perplexed when I hear about “adherence” issues in clinical trials. It used to be called “compliance” but that wasn’t as accurate, and brought up more negative connotations for the research community.
The fact is, for patients, endurance is the best term.
– Deborah Collyar
Staying in a clinical trial, or on any prolonged treatment plan, is an endurance test. There are many unpleasant, and sometimes risky, things that you have to do but hopefully you will get something out of it at the end. Patients hope for positive responses to treatment, or even remission, but that is not always possible.
This is one of many reasons why it is important for those of us who represent patients to be involved in research discussions, from conceptual design to trial completion. We ask questions, such as, “Why do you need x number of these tests? Are they absolutely necessary to answer the questions in this study? What else could be done? Have you thought about asking the patient?”
Let’s work together to make the experience of participating in clinical trials as smooth as possible. Trial participants contribute so much already – they deserve to respect and consideration when we ask them to do things for research.
It’s been awhile since I posted anything – sorry about that. Between excessive travel, new projects with new partners, and unexpected foot surgery, time marched on without me! I actually wrote 2 guest posts that I haven’t mentioned, though. Here is the first one:
Get Real with Patients and Their Advocacy Groups at Clinical Trials Arena. It summarizes a talk I gave at their April 2016 Clinical Operations in Oncology Conference.
People ask me how to work with patients and patient advocacy groups all the time.
Short answer: it depends on the disease, and what type of input is desired at different times. The post listed above offers some ideas.
Two more opportunities are also coming up quickly with eyeforpharma:
- Join Jamie Roberts from CTTI, Victoria Dibiaso from Genzyme and I on August 4th at 11a EST as we discuss how to Drive Value and make the Patient-Centric Trial a Reality. It’s free!
- I’ll also be speaking with many other patient advocates and companies at the Patient-Centered Clinical Trials conference October 10-11th. Be sure to say hi if you see me there.
There are more happenings in this area – look for future posts here on this topic!