Answers for DCIS are coming

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: COMET logo

  1. 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

  2. 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.
  3. SHARE is sponsoring a webinar called “DCIS: What You Need to Know” that features
    SHARE DCIS webinaryours 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.
  4.  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.CRUK DCIS graphic

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!

COMET study team

Some members of the COMET Study team

A Place to Teach Old Drugs New Tricks

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!
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Patient Thoughts on Medical Tests for Research

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.

x-ray film of the brain computed tomography

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.


Time to comment on EU clinical trial result summaries

I just finished my public comments to the EU about the “Summary of Clinical Trial Results for Laypersons.” You can too if you hurry (public comments end on 8/31/16). Here are the instructions. I would appreciate your support on some of the key points listed below.

A bit of background

The European Medical Agency (EMA) issued Regulation (EU) No 536/2014 that does several things, including a requirement for public results summaries for all clinical trials conducted in the European Union (EU). They use the term “laypersons,” which is a real problem that you’ll see below (and further depth at a later time). Annex V of this regulations states 10 requirements.

As you may know, I have led many of the efforts to create clear, useful research summaries for decades now. My comments reflect what I’ve learned, and where problems may appear as these regulations take effect sometime in 2017. Feel free to use any of this information in your own comments (either paraphrased or in total), and share your comments so we can all learn from them. This is our one chance to set the record straight on language and mindsets!

My comments

To the European Commission Unit B4 “Medical products – Quality, Safety and Innovation,”EMA logo

My name is Deborah Collyar,, and
I am responding as an individual.

Thank you for allowing public comments on the draft consultation document for “Summary of Clinical Trial Results for Laypersons; Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.”

While I am submitting these comments as an individual, I’ve led many efforts in plain language results for decades, with more personal hands-on experience than anyone else to which I am aware. This started with my non-profit, the Clinical Trials Information Project (CTIP), that became a catalyst for U.S. National Cancer Institute improvements (Physician Data Query (PDQ),, and eventually As co-chair of the Cancer and Leukemia Group B Committee on Advocacy, Research Communication, Ethics, and Disparities (and now Vice Chair of the Alliance for Clinical Trials in Oncology Publications Committee), I created a process that has produced over 40 public study result summaries. I am also co-chair of the MRCT Center of Brigham and Women’s and Harvard Return of Results Working Group (which the consultation document references), and am directing Health Literacy Missouri’s (HLM) new Plain Language Research Summary service. I have also created many patient advocate opportunities to work directly with, rather than just supporting, researchers and started Patient Advocates In Research (PAIR) to continue these efforts globally.

Overall, the consultation document contains useful information that should help produce research summaries for patients, their families, and the public. This is a critical step to ensure clear, quality information that provides much needed transparency, and I commend your efforts and leadership in this area. One can only hope that other countries’ governmental agencies will soon follow your lead by creating compatible requirements of their own. Below, I list suggestions for additional clarity, important word changes that address unintended barriers, and a few errors.

First, the extensive use of the terms “lay,” “laypersons,” “lay summaries,” “lay language,” “lay title,” and “lay audience” run counter to the goal of producing clear, understandable summaries for trial participants and the public at large. “Lay” is often used to reinforce the superiority of an elitist group (i.e. “professionals”) to separate themselves from an audience they prefer to avoid. The constant use of these terms in the consultant document (and corresponding EMA No 536/2104) sets up an artificial barrier and mindset that creates separate classes where none should exist. Please use more accurate terms, such as “general summary,” “simple language,” “patients,” “people,” “persons,” and “the public.” Specific lines that need to be changed include: 7, 47, 49, 50, 51, 57, 58, 60, 66, 143, 148, 157, 241, 272, 273, 288, 289, and many throughout Annex 1 and the rest of the document.

Another term that should be eliminated (for similar reasons listed above) is “subject,” which is also referred to in Annex V requirement 4 of the EMA No 536/2014. Human beings should not be called “subjects” simply because professionals cannot think of a better term than they use for lab rats. The term “subject” is a verb to patients, not a noun. Please replace it with “participant” or “patient” instead, especially since these words are used throughout the rest of the consultation document.

There is confusion, and possibly conflicting information, between statements made within the consultation document that need to be clarified:

Lines 73/74 say “Develop the layout and content for each section in terms of style, language and literacy level to meet the needs of the general public.” Lines 95/96 say “Communications written for the public should use simple everyday language to ensure ease of reading and understanding.” These statements are incredibly important, and I wholeheartedly support them.

Unfortunately, the statement in Annex 1, page 13 states “It should be noted that the wording of the ten elements cannot be changed but that sponsors can, if they wish, combine categories where this makes sense,” and that the order can be changed. The words used as headings from Annex V’s 10 requirements do not meet health literacy standards and would be very confusing for patients and the public. It is imperative that sponsors are able to change the words of the requirements if they are used as headings on plain language research result summaries. This applies especially to pp. 13-25 that list Annex V requirements 1, 3, 4, 5, 6, 7, 8, 9, and 10. The MRCT template offers good alterative words, and I would be happy to help as you resolve this situation.

There were references to language levels 2-3 in Europe (lines 148-155) and 6th grade level in the US through Microsoft Word (lines 165-175) that do not seem compatible. It was mentioned that Level 2 is approximately high school level, which matches grades 9-12 in the US. There may be additional discrepancies listed in other languages as well (lines 176-231). Please clarify the language levels so they consistently address the same target between various language tools.

All references to the MRCT Guidance Document and Toolkit should include the latest revisions. This includes lines 246-247, 284-287, p. 11, pp. 24-25, and p. 28. The latest versions are posted at

It was mentioned in Annex 1 p. 18 that the term “side effects” could be used instead of “adverse reactions,” but the Annex V heading requirement 6 uses “adverse reactions.” Please clarify that it is acceptable to change the heading names to fit clear, plain language health literacy standards.

Pp. 18 -19 also states that side effects for each group/arm should be listed separately, but if the side effects are the same for each group/arm, this can become confusing and lengthy. For these cases, please allow sponsors to list side effects once and then show the amount of side effects for each group/arm.

There is potential confusion with the way endpoints are described on p.19, Annex 1. Please clarify the kind of endpoints that would fit the statement, “Patient relevant secondary endpoints and results by study arm.” For instance, sponsors should list primary endpoints, and secondary endpoints that are clearly measured regarding safety and clinically actionable results.

The template in Annex 1 has inconsistent grammar and health literacy principles in the suggested wording. Please use action verbs consistently with bullets. Simpler words can also be used throughout the template.

On p. 19, the heading should not have an “s” on “Overall Results of the Clinical Trials.”

Finally, demands that force conformity to the literal interpretation of the law (rather than its intent) are counterproductive when creating useful information for patients, their families, and the public. Please be prepared to quickly address the issues that will surface from this regulation. In addition, regulations and corresponding documents need to change often and openly, and encourage innovations that will develop over time. For instance, while the current instructions are firmly focused on print formats, it is clear that other issues will surface when more innovative web applications are produced. Thank you again for seeking public comments to your documents.

I consent to the publication of all information in my contribution in whole or in part including my name/the name of my organisation, and I declare that nothing within my response is unlawful or would infringe the rights of any third party in a manner that would prevent publication.

How to Work with Patient Advocacy Groups & Patients

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:

  1. 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!
  2. 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!

Happy Summer…