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Patients Against Lymphoma


Research Advocacy Experiences

Last update: 04/25/2014

Helping patients to understand the science, and scientists to better understand patients Ė who are the primary stakeholders in clinical research


Methods in Clinical Cancer Research  | Scientific Committee Participation
What's Hot?  | Regarding Consent

Iím very excited to begin to report on two recent experiences as a patient research advocate.  One purpose of providing this topic is to help future research advocates to know what is expected in this type of advocacy; another is to help the patient community to better understand the purpose of clinical trials.

Research advocates - what do we do?

Liaisons between research and public communities


Identify study priorities of importance to patients


Participate in disease and modality committees in cooperative group research


Develop  advocate-researcher communication strategies


Participate as a voting member in concept review


Advocate for input on study designs at earliest stages


Help to meet challenges of study accrual


Provide mentoring and education to other advocates & the public

The ASCO-AACR Methods in Clinical Cancer Research Workshop 

In no other venue is the role of advocates understood and embraced more fully. And no other event is as challenging and gratifying to all who are involved ... this being a unanimous opinion!

Young researches first submit their concepts to a committee. The winning applicants are then invited to participate in a six day workshop and assigned to different protocol development groups.  Our group had nine young research fellows.  Each group includes 4 faculty members. 

I was honored to participate as a patient advocate with a very talented group of young investigators and an amazing faculty team:  

Dr. Jamie H. Von Roenn,
Professor of Medicine, Northwestern Univ. School of Medicine
Online Profile

Dr. Alfred W. Rademaker,
Professor, Dept. of Preventive Medicine Northwestern Univ. 
Online Profile

Dr. Sandra Horning,
Clinical researcher and clinician at Stanford University,
former president of ASCO, now employed at Genentech.  Online Profile

What is the role of the patient advocates at the workshop? 

As Doctor Lee M. Ellis noted in his opening address, the advocates are here to help the young investigators in many aspects of the protocol and consent document ... such as to keep us grounded:

... Your study protocol is asking the patients to do that!


Is the study question of interest to the patient community?


Is the protocol attractive to patients as a treatment decision?


Are the eligibility exclusions too restrictive?


Are the tests, biopsies, and procedures too burdensome?


Does the informed consent document clearly describe how the study protocol compares to regular care?


Does the informed consent document contain what is needed to help the patient choose?  Is the language too technical?  Will it be understood by grandma? 

(This part was more challenging than any young investigator realized)

I was invited to participate in the panel discussion on Laboratory Correlates, On this I submitted the following background material: Giving Blood and Tissue - Patient Perspectives PDF 

... This year I did not have many opportunities to add to the discussion because of the nature of the questions, but in my introduction I noted that many patients understand the need for predictive biomarkers.  What is worse than getting no benefit ... only the toxicities, which can narrow the range of available options?  

... I also suggested that investigators collaborate with other groups for use of the tissue, to increase the chance that the contribution made by the patient might help them clinically, such as to determine eligibility for a different clinical trial.  Doing this could "sweeten the pot" in cases where asking the patient to contribute is challenging, based on the burden of the procedure.  During office hours, two young researchers thought this suggestion could be helpful.

At Vail, advocates are also asked to lead the discussion in the Protocol Development Groups on the day before the informed consent documents are due; to comment on aspects of the study protocols, such as the exclusion and inclusion criteria; to review and provide guidance on the informed consent documents; attend all the great lectures, and to make ourselves available to the students during office hours - but also to dine with and have amazing conversations with the faculty and young research fellows. 

Karl Schwartz,  Patient advocate

Further Reading

What is the Purpose of Research Advocacy?
The ASCO-AACR Methods in Clinical Cancer Research Workshop http://www.vailworkshop.org/session.html

Comments or Questions?

Scientific Committee Participation

One key to participation is to stick to our areas of expertise -- and to know what we don't know - such as to avoid critiquing the basic science beyond reminding that clinical evidence trumps theories about mechanisms.

About my experience on committee I can only discuss it in general terms Ö until next month when the final decision will be announced to the public. 

It involved reviewing immune therapy proposals made by 27 teams of investigators.  The second phase required a trip to Philadelphia where the 4 finalists presented in person.  This allowed committee members to ask questions of the team leaders and then to discuss the strengths and weaknesses without the candidates present.  We were given specific guidance on how to weigh the strengths and weaknesses of the protocols, such as innovation and the potential of the concept and team to translate their ideas into meaningful clinical benefit in the near term.

So which is more important, the apple or the olive tree? 

Similar to many of OUR treatment decisions (that we make with the help of our trained physicians) we canít know before-hand which approach will bear the most fruit - so there is no clear cut right answer.   The proposals inspired a spirited debate. The final vote was a VERY close call. 

The news will be exciting.  

Comments or Questions?

What's Hot?

In this topic I will share impressions about a renewed enthusiasm for immune therapy - based not on theory, but on unexpected results in clinical trials in cancers that were not expected to be immunogenic  - responsive to vaccine and other immune-modifying interventions.

More to come.  

Comments or Questions?


Regarding Giving Our Consent to Go into a Trial

In this topic I will share notes on the informed choice process and the consent document - that will be of interest to patients who are considering a clinical trial.

Did you know that:

The informed consent document should focus on how the study is different from regular care.
We have the option to go off the study for any reason, such as

the study protocol isn't helping much, or the toxicities are too much, or to take advantage of the response - as a "bridge" to transplant. Or just our preference.

The informed consent document is not a contract. The decision to stay or go is based on what is best for the individual patient. The science is second.
Disclaimer:  The information on Lymphomation.org is not intended to be a substitute for 
professional medical advice or to replace your relationship with a physician.
For all medical concerns,  you should always consult your doctor. 
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