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

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.

 

Patients Want Their Data Shared

Patients also want to be:

  • Respected for their contributions to science and medical advances. Those contributions include samples from their bodies (biospecimens), information (data), experiences (input), and sometimes their very lives.
  • Protected from harm and misuse of sensitive data about themselves, their family, and/or their culture or ethnicity.

As long as we are respected and protected, we will participate in clinical research and learning healthcare systems so researchers can find better ways to treat and prevent diseases and medical conditions.

What & Who

This post focuses on data from past “legacy” cancer clinical trials. The Patient AdvocateProtectionCommittee in the Alliance for Clinical Trials in Oncology drafted a resolution to add the patient voice to the groundswell of support for data sharing.

Why?

  1. People who join cancer clinical trials are often asked to donate their tissue and data for future research.
  2. When patients give consent for research, they expect their information to be shared.
  3. Unfortunately, many hospitals, clinics, academic centers, or research groups will not release information to other researchers, even though patients gave their consent.
  4. This does not honor or respect patients who want to contribute to research.

Your Call to Action

  • Please read the resolution, sign on, and share it with your networks and organizations. While this resolution deals with cancer, its intent is to help all medical conditions.
  • Include patients in data sharing activities.

“Today, oncologists and cancer researchers realize that they can’t [advance cancer progress] alone… What’s required today extends beyond any individual or any individual discipline, beyond medicine itself… It requires somewhat of a change in mindset. It requires a lot more openness – open data, open collaboration and above all, open minds.

– Vice President Joe Biden, ASCO Speech

Thank you!

How Do We Get Better Research Results?

We learn about diseases and illnesses from research studies. Some focus on treatment (clinical trials), while others study groups of people (observational studies). Unfortunately, many studies are unclear, wrong, or can’t be easily transferred into everyday medical practice.

Study designs actually matter. They determine whether a research study helps real patients or just asks esoteric questions to further careers or make profits.

There are many ways to improve research studies. Let’s start with observational studies.

Observational Studies

There is one very simple concept to remember about observational studies:

different-paths_M15wj8_dCorrelation does not mean causation!

In other words, just because A and B fit together (are related, associated, or correlated with each other), it doesn’t mean that A caused B to happen.

HealthNewReview.org posted a great article about this, called Observational Studies – Does The Language Fit The Evidence? – Association Versus Causation.

There are several types of observational studies. This chart explains the pros and cons of each type.

F. Perry Wilson suggested a (better?) way to design observational studies in a recent MedPage Today post. A regular problem with these studies is that real life includes many things (factors) that researchers don’t include in studies:

“There are always other confounding factors that we didn’t think about, or we didn’t measure.” – F. Perry Wilson, MD

He suggests a method that helps build in factors that traditional study designs often overlook. Wilson did a great job of explaining both of these concepts in his article:

  • Randomized clinical trials (RCTs), known as the gold standard of clinical research, and
  • Instrumental variable analysis (IVs), which has not been popular, even though it has been around for over 80 years.

Study designs need to answer questions that apply to real people. This is why some of us work with study sponsors to infuse the patient perspective into study design and implementation. In case you are interested, here are some examples in articles and presentations. Just let me know if you’d like to join us.

There are lots of issues in trial design – this is just one. Future post material – aren’t you excited?! Please share your thoughts or add resources on observational studies in the comments. Thanks!

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

Clinical Trial Patient Summaries Win!

Congratulations to the MRCT Center of Brigham and Women’s Hospital and Harvard and team for winning the 2015 Award for Excellence in Human Research Protection from the Health Improvement Institute! The winning project recommends ways to write public summaries after a clinical trial is over.

Why Is This Important?

  • People join clinical trials (research studies) so researchers can learn if new treatments, tests, procedures, or other things work better than what is now offered to patients.
  • People who join the trial are research participants, and contribute a great deal – sometimes their very lives.
  • Participants are told they’ll learn important things about the study, but they rarely receive a summary of what happened during the trial. Until now (hopefully).

Thanks, Europe!

The European Medical Agency (EMA) created a new rule that says ALL clinical trial sponsors must create a public summary within 1 year after a clinical trial is closed (6 months for trials with children). This rule scared sponsors (aka drug companies, government, and private funders), so the MRCT Center assembled a Return of Results (ROR) Working Group (WG) to help.

Why did it take a government regulation to make this happen, you might ask?
Oh, they must have been busy with things more important than telling people what happened (sigh).

What is the Return of Results (ROR) Project?

sign direction expect-result made in 2d softwareThe MRCT Center ROR project focuses on patient needs (for a change!), instead of just the research system. This means including principles about plain language, health literacy, and how to explain numbers (numeracy) – making sense of clinical trial results for normal people.

The ROR project includes:

  • A Guidance Document: how to set up a process to create patient summaries.
  • A Toolkit: with helpful templates, non-promotional language, and checklists.

We studied a few groups who actually create clinical trial result summaries, like CISCRP and the Alliance for Clinical Trial in Oncology (disclosure – I run the summary project there).

The Award

“The award program recognizes submissions that our judging panel determines have demonstrated excellence in promoting the well-being of human research participants.”

– Dr. Peter G. Goldschmidt, President and Founder of Health Improvement Institute

Quite a mouthful, but nice recognition! They agree the ROR Project puts patients first.

Thanks to All

Thank you

Thank you

As Co-Chair of the MRCT Center ROR Working Group, along with Laurie Myers from Merck, we thank all 53 team members (pp. 2-4) for creating ‘how to’ information for all clinical trial sponsors to create plain language study result summaries for real people. Thanks also to Barbara Bierer, Rebecca Li, and the MRCT staff. We’ll continue to update as new information becomes available.

A Plea to Sponsors

The tools exist, so let’s get started NOW! Don’t wait for the EMA ruling or for the U.S. Food & Drug Administration (FDA) to follow suit. Patients, trial participants and the PUBLIC want these NOW. And some of us can help. Really. Contact me!

After all, it’s the right thing to do AND you really need some goodwill, but that’s another story…

What YOU Can Do

Please ask for a public summary of any clinical trial you want to know about. You can find most trials listed at https://clinicaltrials.gov/. And ask them to stop calling them “lay” summaries (what does that really mean, anyway?).

More information on clinical trial result summaries is in this post.

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.