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…

Getting Real about Patients & Clinical Trials

I’ve been asked countless times to write about patients and clinical trials. Guess it’s time to share what I’ve learned, along with other patient advocates, as we work beside researchers in the proverbial trenches. Just so happens that this post coincides with April Fool’s Day – hope that’s not an omen!

Why this series?

This is the first in a series on Patients & Clinical Trials (CT). Why? Because clinical trials are really the only tried & true way we get new diagnostics, treatments, and preventive approaches to people. For all diseases and health conditions.

But the research system isn’t very good at it, even after 70+ years. It’s not for lack of trying – BILLIONs have been spent on tweaking existing structures, but perplexing problems persist.

Heads up on CT activities

Other themes will also emerge, based on over 20 years of changing research and medicine culture (or at least trying to). In the meantime, here are some of my activities in the CT world:

Event Inscription on Sign

Other activities:information-orange-circle_fkMzuUIu_L

  • The California Technology Assessment Forum (CTAF), part of ICER, released their recommendations from the February meeting for new drugs in diabetes and asthma.
  • CTTI just released materials from an expert meeting about the issues surrounding FDA streamlined approvals for new antibiotic drug development. A summary will be posted soon. You can also read a past post called Antibiotic Resistance – It’s Complicated!
  • Cures Within Reach focuses on ways that existing drugs can be used for other purposes. More from this group in a guest blog post here soon!
  • Two DCIS studies are being funded by PCORI to help answer treatment questions for this pre-cancer, and learn how women feel about them. You can also read a past post called When is ‘Carcinoma’ Not Cancer?
  • The Center for Medical Technology Policy (CMTP) is working on recommendations to allow patients to switch treatments in a clinical trial if their cancers keep growing.
  • The Metastatic Breast Cancer Alliance (MBCA) is creating a summary of their February meeting from the Research Task Force to Advance Progress.
  • The NC ProCESS project on prostate cancer has convened a patient advisory board to help communicate effectively with prostate survivors in their study.
  • Two groups I’m working with (MRCT and the NCI NCTN Biospecimen Banks) are discussing how to handle the challenges of giving individual research results to patients.

You can also read past CT posts about:

There are many other clinical trial happenings – these are just some of the ones in which I’m involved! Yes, it’s heavy on cancer, but remember that cancers cover the gamut from rare diseases to millions of people.

Updates will be posted regularly. Let me know what you’d like to hear about. TTFN.

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.

6 Ways to Turn Data into a Good Read

Ever take a bunch of facts and turn them into something readable? For real people? From many dry scientific journals? When sources disagree? Vehemently?

That is exactly what UCSF researchers Thea Tlsty, PhD, Philippe Gascard, PhD, and I did. Here is what we learned in order to help make sense out of a major worry for women.

But First, Why?

Computer generated 3D photo rendering.

We want to help ~60,000 people (mostly women) who deal with a condition called Ductal Carcinoma In Situ (DCIS) each year. It’s often over-treated, so women want to know what to do. Many questions surround DCIS, and researchers argue at every step along the way.

“DCIS means cells inside the breast duct look and behave like cancer cells. DCIS cells, though, stay inside the ducts and do not travel anywhere else in the body.”

Excerpt From: Deborah E. Collyar. “DCIS Dilemmas

For instance, is DCIS really cancer? Some say no, and want to change its name. Others treat everyone as if they have breast cancer. Still others want to find the 1 out of 10 women (11%) who will eventually get invasive breast cancer so they can be treated, or find the next 11% who might get another DCIS that won’t affect how long they live.

“When you put a frightening term like carcinoma on a lesion that, on average, doesn’t go on to invade normal tissue, that can prompt women who are justifiably frightened of the word cancer to have therapy that’s every bit as aggressive as if they had a true invasive cancer.”

Barry Kramer, Director, Division of Cancer Prevention at the National Cancer Institute in an article from Proto

A few focus on finding almost 8 of 10 women (78%) who will only have DCIS once, and don’t need to endure the long-term problems of over-treatment. Our efforts turned into a new eBook called DCIS Dilemmas: Discussions about Ductal Carcinoma and the Research Behind It. So, how did we do it?

How to group complex data

1. Gather a Range of Data

Research is important, but don’t expect simple answers. We scoured scientific studies (in journals and conferences), and separated conclusions and opinions into different categories. We set a rule that all of the facts we used had to come from at least 2-3 different sources. Articles like this one from HealthNewsReview.org were also helpful.

“New DCIS study, news release lead to (very) mixed messages: ‘And we wonder why patients get confused’”

Dave Mosher in a HealthNewReview.org article

2. Find Out What is Important to Readers

Before starting the eBook, we surveyed 3 groups:

Important Stamp Shows Critical Information Or Documents

  • Women who were cancer-free
  • Women who had DCIS
  • Women who had invasive breast cancer (IBC)

We also held a DCIS Forum in San Francisco to present real information, dispel myths, and hear directly what women want to know.

3. Put It in Perspective

While DCIS is serious, it is not fatal. Unfortunately, many women are led to believe they have breast cancer and are treated this way even though most (over 3 out of 4) will never have another event. The important part is to figure out who is actually at risk for a future invasive breast cancer and what they can do about it.

4. Explain Why Everyone is Confused

Puzzled Confused Lost Signpost Shows Puzzling Problem

DCIS is as confusing to doctors and researchers as it is to patients. A lot of this is due to old ways of thinking, and old terms that are still used. For instance, most doctors and researchers talk about the risk of a “recurrence,” meaning another DCIS or breast cancer. This is actually impossible for DCIS! The old mindset treats DCIS as if it is cancer, not a pre-cancer. It’s time to change that.

5. Explain What Can Be Done About It

It was clear from women that they want to know what to do about DCIS. So, we shared information about:

  • How DCIS is diagnosed ebook DCIS Dilemmas - older woman w tablet
  • The different kinds of treatment used (including Active Surveillance)
  • What risks exist for all women, as well as risks after being diagnosed with DCIS

We also listed current research that will hopefully produce clearer answers in the future.

6. List Resources for All to See

We wanted full disclosure on all of our sources, so we listed everything we reviewed in categories for those who want more information. We also flagged some of the controversies so people can make up their own minds.

What Do You Do?

List your ideas in the comments, so we can learn from each other. We’d also appreciate your feedback on our approach. If you’re interested, check out DCIS Dilemmas: Discussions about Ductal Carcinoma and the Research Behind It and let us know what you think!

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.

7 Ways to Keep Your Funders Excited

This was originally posted on December 9, 2014 for nFocus Solutions, which provides great data solutions for non-profits, government agencies, and communities. Check them out (after reading this post, of course)!

Do you know what funders want most?

They want tangible results they can see and understand. They also want to feel like they are part of your vision. After all, they are helping you reach your goals.

To be proactive and help funders feel engaged with your organization’s mission, you don’t need to hand them a crystal ball with an image of your organization. Just give them clear, concise facts that give them a clear picture of your programs. Your future will soon reap rewards.

Try these 7 methods to keep funders engaged, motivated and excited:

1. Remember WIIFM

‘What’s In It For Me?’ is a tried and true adage, and funders definitely wonder about this when they hear your pitch. But your story isn’t about you; it’s about growing your community through creativity, determination and follow through. Show them how it feels to make things happen by drawing them into your success.

For example, you could share your program in a newsletter that illustrates ‘before’ and ‘after’ reading levels or shows an increase in attendance and time. This can tie your accomplishments back to their funding. Be sure to avoid simply bean counting and demonstrate factual results.

2. Collaborate for long-term gain

3d businessmen inside gear. Teamwork concept. Isolated

Funders appreciate groups that impact entire communities. They realize that no one can do it all, so they often fund partnerships for impact. Take the challenge: develop a plan with organizations that complement your services. According to Stacie Hines, current project manager at nFocus Solutions, “Funders like to see data share agreements—it proves you’re working together.”

3. Be nimble

Flexibility is key, and so are tangible goals. That might mean changing your methods and managing your data. Set short-term goals that help reach your long-term vision. Try tracking your efforts with a logic model that connects inputs, activities and outcomes to prove your impact over time. “Having a defined approach will help you stay focused,” Hines explains.

4. Identify trends as they happen

To stand out, learn where your community needs help. Take the pulse and track real data that walks through your doors. When Hines was employed at Reading and Beyond in Fresno, Calif., she helped them develop their Promise Neighborhood, or federally-supported communities that aim to improve educational opportunities for youth. She reminds us, “In today’s world, measuring outcomes is critical to prove your impact.” The good news: you don’t need a crystal ball. Instead, turn your data into knowledge and lead your community to decisive action.

5. Don’t forget your staff

Attractive female employee pointing at blueprint with her African colleague near by

Your staff can make or break your organization. They also have ideas about how to make your programs shine. Funders sometimes connect to the front line in order to get the real story, so make sure your employees understand your strategy and how their efforts affect the goals and mission.

6. Bring funders with you

Today’s funders are active; they want to follow your progress. Be sure to communicate regularly—not just when it’s time to ask for more money. They may help you avoid potholes that you don’t see at full throttle. Hines adds, “Ask them if they would like to volunteer or attend events where your clients will be.” At the Fresno County Economic Opportunities Commission, Hines invited funders to contribute their time and talents to provide a direct way to connect on a personal level.

7. Be specific

When you ask for money, be specific about programs and share the whole cost. Funders don’t have time to figure out what ‘support’ means. Provide a menu of different projects and break down numbers over time. You can also request funding levels and in-kind donations. And keep asking until they say no, then schedule requests on a yearly basis.

These steps not only keep funders happy and engaged, they can re-energize organizations and ultimately impact communities.

All content © 2016 by Deborah Collyar and nFocus Solutions, Inc.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.