Three Ways to Improve Clinical Trials through Crowdsourcing

Three Ways to Improve Clinical Trials through Crowdsourcing

Matthew S. Katz, MD

@subatomicdoc
Jan 21, 2014
At my hospital, we are committed to offering a lot of clinical trials in the community. But it’s hard—nationally, only about 3% of patients with cancer participate in clinical trials. Even at some academic centers, it may be below 10%. With less research funding available, we need to find new ways to make it easier and cheaper to do clinical trials. There may be ways to harness crowdsourcing, or collaboration of many people online, to help for little or no financial cost. Here are three possible ways to help:

Improve Interest in Trials

Research shows that better understanding of clinical trials can improve participation rates. Speedier trial accrual means we get answers to important questions in less time. So why not aggregate online resources that educate patients well? If people could share favorites, let others vote on them and make comments on suggested improvements, we could develop better resources for education both in clinic and that patients could review at home or on a smartphone.

Language or cultural barriers can also pose problems. If the content were made freeware or used a non-commercial Creative Commons license, the passionate patients, caregivers, doctors, or anyone could "remix" great content through free translation or more culturally sensitive ways to describe clinical trials.

Of course, there would have to be some monitoring for conflicts of interest from content providers, but with comments and voting you would have a way to call out any ethically questionable material.

Having crowdsourced, quality patient education materials in a patient-friendly format would be a great asset. And it wouldn’t hurt if similar crowdsourced educational tools were available to doctors as well—then maybe more of us in the community can offer more trials.

Open Clinical Trial Development in Cooperative Groups

Some of the brightest minds in cancer care design clinical trials. But if draft protocols were posted online for public comment and recommendations for improvements? Patients, community doctors and nurses, administrators, and advocates all may find problems that limit the ability to offer a specific trial. Wouldn’t it be nice if we needed fewer trial revisions because amateurs can help the experts? And the more that trials had “buy-in” by listening to suggestions, the more people might be willing to offer those trials.

Give Amateurs Tools to Build Trials from Scratch

As a community doctor, I don’t have experience writing protocols or the time dedicated to clinical research that I’d like to still remain active in creating new research. What if we made it easy for people to develop more research ideas than academic oncologists have time to do?

Many of the parts of clinical trials are very similar, with certain essentials. What if we had a website that allowed people to build components of a clinical trial to address a certain problem? It would require a less technical/academic user interface that could then select options, like building blocks, to put together novel concepts for trials. With those options linked to macros and other built-in content, the “layman’s” idea could be put into a rough draft of a protocol.

Then let people vote and comment on that draft protocol and leave it as an open–source free idea for any hospital or clinical trials group to buff up for appropriate implementation. But wouldn’t it be great if there were a way to let amateurs help the experts on the front end, too? It might relieve academicians of doing all the work and have a sense of what trials may be more likely to succeed with accrual. Let patients and non-academic doctors help—that’s where the numbers are for successful trials!

Those are a few of my ideas. Some cost would be involved in building the right platforms to share, but I think the rewards would be great.

What do you think we could do to use crowdsourcing for clinical trial development and accrual?

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Comments

Roni Zeiger

Jan, 23 2014 12:39 AM

Matthew, thank you for the thoughtful post. I agree that better tools are needed, but perhaps an even bigger barrier is cultural. As a clinician and former academic, we tend to think of patients as passive participants in our trials or passive recipients of our care. This is changing on the health care delivery side with more patient-centered care, the e-paitent movement, etc. On the research side, however, there is more resistence to involving patients as collaborators. It's clear this must change not only from a patient-centeredness perspective, but also -- as you point out -- to increase participation in trials.

Roni Zeiger, MD
Co-founder, Smart Patients
(Conflict of interest: some of our work involves asking patients for feedback about clinical trial design)

Matthew S. Katz, MD

Jan, 23 2014 8:04 AM

Dear Roni:
Thank you for taking time to share.  I agree completely.  Too many health professionals see active patients as a threat.  For clinical trials, patients need to be informed and engaged so this philosophical change is an essential component for more clinical trials accrual.  If doctors aren't willing to collaborate and take time to explain, then clinical trials fail to accrue.

My hope is that we can find or create tools that facilitate collaboration and education for doctors, patients and other stakeholders.  Clinical trials aren't for everyone.  But I want to find ways to make more trials available in my community.  I'm open to trying anything that may help.
Matt 

To readers: Smart Patients has a very user-friendly clinical trials search tool.  I use it as an alternative to clinicaltrials.gov (No financial conflict, but I am interested in using it).

Molly Lindquist

Jan, 23 2014 10:58 AM

Thank you for the insightful post, Dr. Katz. As a breast cancer patient, I was very lucky to have been treated by a group of doctors who saw me as a member of the care team. I also have a physician husband who was able to translate some of the more complex medical jargon for me. I know that not many people have the luxury of this personal medical advocate, and there is definitely a great need for lay-friendly accessibility to research, particularly to address your points of recruitment and patient involvement. I know as a patient myself, I wanted to be involved and pay it forward after my experience. Through my work at Consano, I have been fortunate to work with a number of researchers who are  embracing the idea of patient involvement. As Dr. Zeiger points out in his comment above, patients are definitely shifting from passive participants to drivers of change. It is exciting to see, but we still have a lot of work to do.

Matthew S. Katz, MD

Jan, 23 2014 11:06 AM

Dear Molly:
Thank you for sharing your experience.  It's wonderful that you have been able to become an advocate for collaborative clinical trial development.  There is a lot of work to do, but it's definitely possible.  Many community docs, like myself, see problems every day that deserve study.  We usually don't have the resources or time to get involved in clinical trial design, but I think the more people who can help the better.  We just need the right nomenclature/language, tools and environment to allow the amateurs to help the experts.
Matt 

Mehmet Sitki Copur, MD, FACP

Jan, 28 2014 12:34 AM

Great ideas! but good luck with it! Maybe, only in a "dream world of a clinical trials system without so much non-sense regulatory burden". The biggest challenge to clinical trials is the current unthinkable regulatory requirements. From telephone book-thick consent forms, to cumbersome adverse event reporting system, to HIPPA, to IRBs, to case report forms, to retrospective audit systems, to countless paper or electronic submissions, and to so much more! Our current clnical trial system is in a state of paralysis thanks to very cumbersome rules and regulations, and it is only getting worse day by day. Regulatory burden is the number one problem! without solving this problem nothing will improve. It is the elapahant in the room, nobody even wants to talk about it, let alone try to tackle it. I would bet this idea/project would give rise to a number of new rules and regulations that are already too many and unbearable. Unless, scientific community all get together and stand up against this paralyzing regulatory non-sense, the advancement of science will not be any better (or worse for that matter).

Matthew S. Katz, MD

Jan, 28 2014 6:55 AM

Mehmet, thanks for taking time to bring up an important issue.  I have heard others raise the issue of regulatory hurdles to clinical trials.  I'm sure there is room for improvement.

As for my idea, I would think that a transparent wiki or collaborative platform may allow regulators to give clinical trial designers pointers early in the process that might lessen revisions and other delays that aren't addressed until a finalized protocol is submitted.  What if regulators were partners in the process rather than being seen in an adversarial role?

By creating a collaborative trial building platform that engages regulators in a positive way,  maybe the changes it would bring will address your concerns.  Maybe not but I think it's worth a try.

Michael A. Thompson, MD, PhD

Jan, 29 2014 8:04 PM

Matt - 

Great post and commentary.

Of note the cooperative group Alliance notes:

"The Alliance for Clinical Trials in Oncology welcomes concept submissions from the general public." 

See site:
https://www.allianceforclinicaltrialsinoncology.org/main/public/standard.xhtml?path=%2FPublic%2FSCRC

Also, I am working on a few interesting trial development and consent approaches, but will comment more once they are farther along in development.

Mike 

Matthew S. Katz, MD

Jan, 29 2014 11:37 PM

Mike,
Thanks for sharing the Alliance resource.  I may take you up on it -- I'm writing up a phase II trial for prostate cancer as we speak and will consider submitting it.  I also look forward to hearing more when you can share it!
Matt 

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