Editor’s Note: today’s post is by Bruce Rosenblum, VP of Content and Workflow Solutions of Wiley Partner Solutions, former CEO of Inera, and 2020 NISO Fellow.
I’d like to share an exciting article that recently appeared in the Wiley journal Muscle & Nerve: “Safety and activity of anti-CD14 antibody IC14 (atibuclimab) in ALS: Experience with expanded access protocol.”
Well… first, a little background.
Becoming research data
Six years ago I was diagnosed with ALS (also known as Motor Neurone Disease). Shortly after that, knowing I had an 80% chance of dying within 5 years, I enrolled in a phase 3 clinical trial for a promising experimental treatment. For me, the clinical trial was about trying to extend my life. But by the time the trial concluded 11 months later, I found myself thoroughly enamored with being part of the research process. Participating as a patient was a deeply meaningful experience, as was working with a group of caring, compassionate researchers dedicated to solving the mysteries of this devastating disease.
Inspired by the opportunity to use my failing body to advance knowledge of ALS and to spend time with amazing researchers, I signed up for every available research study (including two voluntary spinal taps), while my medical team tried to find another clinical trial for which I was eligible. In early 2020, I was distressed to learn that I no longer qualified for further clinical trials. Then, in May of that year, the Healey Center at Massachusetts General Hospital (MGH) offered me the chance to participate in an Expanded Access Protocol (EAP) to try an experimental “compassionate use” ALS treatment. ALS treatment options are limited, so I was thrilled to participate.
The article in Muscle & Nerve publishes results of this EAP. Here’s why I’m excited about it:
- Call me a data geek, but I think it’s pretty cool to be a data point in a published research paper (1 of n)! Especially when you work in research publishing!
- It’s even cooler when that research paper is published in a Wiley journal — this feels like family for me, because I’m part of the Wiley team.
- Dario Gelevski, the first author of the paper, is an early-career research coordinator at MGH. I’ve watched him grow as a researcher over four years, in part through the incredible mentoring he receives from Merit Cudkowicz, Chief of Neurology at MGH and one of the world’s top ALS clinicians and researchers.
- I’m excited to see young researchers like Dario in action because they are the future of curing ALS. It’s a privilege for me to work with Dario and everyone on the incredibly smart, dedicated, and compassionate team that Dr. Cudkowicz leads.
- The article concludes that “EAPs can provide valuable information to improve the clinical trial process.” ALS clinical trials are incredibly challenging, and the approach taken in this EAP moves early-stage ALS research in a new direction that can lead to better-designed clinical trials. It’s exciting to be part of research that is moving the needle!
So maybe now you’re a little bit excited. Thank you!
But that’s only half the story.
Over the six years since I was diagnosed with ALS, I’ve come to know many of the co-authors well as I participated in this EAP and other ALS research. They know I work at Wiley, and sometimes our conversations turn to the subject of their challenges with the publication process. Suddenly, I’m not just a patient; I’m an ambassador for Wiley, and for the entire scientific publishing community.
Here are some things I’ve learned from these conversations:
Researchers are frustrated by overly complex author instructions. Nothing demotivates an author more than spending three hours carefully updating a manuscript according to a journal’s very detailed formatting instructions, only to receive a desk rejection.
We know that a lot of this formatting is now handled by software or vendors — so why should researchers spend their time on it? The time authors waste on formatting is documented in PLOS One and more recently in BMC Medicine. What’s the answer? All journals should adopt format-neutral submissions, now. Editors and reviewers should evaluate content quality, not formatting perfection.
Researchers are exasperated by submission and peer-review systems that require an hour or more of their time to submit a manuscript with 15 or 20 authors because they have to manually copy and paste the author list and other metadata.
Some submission systems have significantly improved this process, while others have lagged behind. (Researchers can tell me, while rolling their eyes, which systems are most difficult to use.) If an author cannot complete the initial submission process for a 20-author paper in 10 minutes or less, your submission system is not doing its job!
Researchers still receive too many author proof queries that could be resolved by production teams or by improved workflow automation. When the author of the Muscle & Nerve paper received the proof, he contacted me with questions about some of the author queries, many of which should have been dealt with by the production team. We need to audit our processes to ensure that the only queries authors see at proof are those that can’t be resolved without their input.
These issues, and many others, are works in progress across the scholarly publishing world. A recent Scholarly Kitchen post commented that “the key resource in research is not money but the time of researchers” — and the challenges I’ve described take valuable time away from what researchers love to do: research.
My personal perspective is a little different. Researchers have only so many hours in a day; if they can spend one less hour on a research article because we have implemented improved workflows and better technology, that’s one more hour they can spend on research to try to save my life, and the lives of all ALS patients.
The OA question
As a patient and as a certified Northeast ALS Consortium Patient Research Ambassador, I love open access!! It’s frustrating to research a topic and find something promising, only to encounter a paywall. And ALS researchers want their articles freely available to the ALS community, including patients. However, as a publishing professional whose career predates online journal publication, I have witnessed the dramatic change in our business brought by the Internet and OA, including the economics of electronic publication. I understand the challenges of flipping our business rapidly to a new economic model.
The impact of these changes often leaves researchers, who are neither publishing experts nor economists, asking me: “Why are Open Access publishing fees so high?” Each time I’m asked, I patiently explain why electronic publishing systems today are more expensive to design, implement, and update than the print publishing processes of 30 years ago. But the fact that I hear this question so often tells me that we need to do a better job of explaining to our customers what they’re paying for and why it’s valuable.
Today’s scholarly publishing customers are not just institutions and libraries. Increasingly, the customer is the funder — or, in many cases, the individual researcher who is not part of a large-scale OA publishing deal and has questions about what they’re paying for with their valuable research funds. When early-career researchers gleefully show me TikTok videos mocking 5-digit OA fees, we should be concerned about how we’re perceived by our future customers.
You can be research data, too!
You don’t need a fatal or chronic disease to participate in clinical trials and learn about researchers’ publishing challenges firsthand! Many clinical trials and studies, including some I’ve participated in, also need healthy control volunteers.
You can volunteer to be research data! How?
- Go to https://clinicaltrials.gov/ to access the NLM clinical trials registry, which lists trials in the United States and more than 200 other countries around the world.
- Enter the name of a condition or disease you’re interested in — perhaps one that has affected someone in your family.
- Press “Search.”
- On the results page, check “Recruiting” and “Accepts healthy volunteers” in the left-hand column and press “Apply.” For example, here is a list of active studies and trials for colon cancer that are accepting healthy volunteers.
- From the results page, you can narrow the results by other criteria, such as geographic location, age, and gender.
- Choose a trial, contact the researcher listed in the trial information, and get involved!
I encourage all of you reading this post to participate actively in clinical research. It’s a great way to learn more about the daily jobs and lives of our customers, and being research data can be part of your life legacy.
Thank you to Sylvia Izzo Hunter for your insightful comments on multiple drafts of this post.