BioNews Clinical Will Bring Trials Into ‘Continuum’ of PF Care

Grace Frank avatar

by Grace Frank |

Share this article:

Share article via email
Ofev for Japanese patients | Pulmonary Fibrosis News | INBUILD trial subanalysis | trial data

A new service, BioNews Clinical is seeking to bring more patients into relevant clinical trials by helping all involved — scientists, pharmaceutical companies, people with diseases — regard these studies as part of continuing care.

“Today what happens is that the conversation about patients participating in a clinical trial is not part of the routine conversation that patients and physicians have. Those two things are basically disconnected,” Marcella Debidda, PhD, president of BioNews Clinical, said in an interview with Pulmonary Fibrosis News.

“To me … facilitating the connection of patients to ongoing clinical trials that are right for them is really a continuum in their care conversation in an ideal world,” said Debidda, a molecular oncologist who more than 10 years ago moved from basic into clinical research. She started with the Harvard Clinical Research Institute (now the Baim Institute) and, soon after, Science 37, both organizations engaged in carrying out studies more open to patients and their particular concerns and needs.

The reality, she added, is that trials too often are presented to people as if “that is their last choice.”

BioNews Clinical wants to change that, helping to advance the clinical research that is essential to bringing new treatments to patients — especially those with rare diseases, for whom few, if any, disease-modifying medications exist, and those chronically ill and dependent on therapies.

Recommended Reading
Pulmonary Fibrosis Awareness Month | Pulmonary Fibrosis News | illustration of awareness ribbons

Pulmonary Fibrosis Awareness Month Honors Those Touched by PF

Its Sept. 7 launch involves a pilot run into connecting an ongoing study in idiopathic pulmonary fibrosis (IPF) and another in multiple sclerosis (MS), with patients who, through surveys, expressed interest in such research and being part of it.

A pilot in myasthenia gravis, a rare neuromuscular disease, is due to get underway next , with other rare and chronic diseases to follow.

Ongoing trials in this service, for now, will be those based in the U.S.

Gradually, Clinical will open to trials in all the rare and chronic disease communities that its parent company, BioNews Services (also the publisher of Pulmonary Fibrosis News), fosters through its disease-specific and free platforms. These platforms range from news articles by science writers and columns by patients and caregivers, to forums, social media, podcasts, and information pages devoted to approved or experimental treatments and various disease aspects.

More global trials will be included eventually because, especially in rare diseases, sufficient numbers of patients are difficult to recruit in a tightly defined location, and size is necessary to support statistical — reproducible — confidence in trial results.

Patients who voice an interest in trial participation through surveys run by BioNews Clinical are selectively matched with those brought to it by sponsors — whether pharmaceutical companies or independent researchers and institutes — by Debidda and Liza Bernstein, a patient engagement specialist. 

Typically, trials recruit by a sponsor contracting with a vendor to find patients. “It’s the narrative, ‘Oh, I need you, therefore I look for you,’” Debidda said.

BioNews, in contrast, “had already brought 2 million people together” across the diseases it covers, she said. “The communities already existed. The dialog was initiated. … BioNews Clinical is the aftermath of a reality that is alive and thriving.”

For the MS trial, matching involves a closer look at the 2,264 respondents who identified as patients — specifically, the 97.58% expressing a willingness to be contacted for a “relevant clinical trial.” The enrollment process itself is largely handled by a trial’s sponsors, as BioNews does not collect personal health records.

People have the right to decline participation at every step, beginning with an initial call from BioNews Clinical to determine continued interest.

A similar process is underway for the IPF study. Of the 632 survey respondents who reported they have pulmonary fibrosis, 98.7% voiced an interest in being contacted to possibly take part in a trial.

BioNews Clinical is still in “an initial phase,” Debidda said, with learning and growth “primarily being dictated by the results we will obtain” in the months ahead.

“But the workflow is working,” she added. “The reason why we call it a pilot [effort] is because we want to understand what is our ability to convert those leads in patients who say ‘Yes, I want to be connected,’ into patients who are successfully enrolled in a study.”

Debidda sees three main issues as barriers to participation: basic awareness of relevant trials underway; study protocols that too often are not updated, overly restrictive, and difficult for patients to understand; and “logistics,” such as onsite visits requiring travel that people who are ill cannot easily make.

She bases these assumptions on her experiences with patient communities, speaking of her surprise when an MS patient, during an advisory group meeting with Harvard, named highway driving as a top obstacle to continued trial participation.

“I was sure I was going to hear about spinal taps or pain,” Debidda said. But this person talked of having had a flare due to anxiety and sleeplessness caused by the requirement of driving to reach the clinical site, given the disease’s physical and cognitive toll.

And she bases them on insights voiced by people with rare and chronic disease who are part of BioNews. A number share their trial experiences and hopes on the Patient Community section of the service’s website.

“We reach nearly 90% of existing rare disease patient populations,” Debidda said of BioNews. “Nobody else has that.”

Recommended Reading
PF breathing exercises | Pulmonary Fibrosis News | lung health

Daily Breathing Exercises Seen to Slow Progression in IPF Patients

An important future goal for BioNews Clinical is to expand beyond recruitment and help sponsors in designing trials — whether traditional or, ideally, “hybrid” studies that mix on-site visits with virtual contact — that are more aware of patients’ needs and wants.

“When we design clinical trials … they make perfect scientific sense. But they can really fail to take into consideration what patients can actually do,” Debidda said.

BioNews Clinical currently offers those working on trials an “à la carte menu” of sorts through its Sponsors section, but hopes eventually to incorporate patients — their disease journeys, experiences, and priorities — into the very design of trials.

Such a move serves all involved, Debidda said, noting that published studies into trials’ financial burden, while limited in number, have found significantly fewer protocol adjustments needed when patient views are involved.

“There are figures attached to what happens every day that a drug is delayed getting to market,” she said. “If we are able to decrease the number of protocol amendments, it means that trials are completed sooner, which means a drug is approved and goes to market faster, which means the total cost for development is a lot lower.”

This undertaking, while central to positioning clinical trials as part of the “continuum” of patient care, is a ways off, Debidda noted. Emphasis now is on the pilot efforts with ongoing trials.

Still, “we’re looking at how we can, or how we might, involve patients in everything that is related to trials’ design,” she said, “so we can design better science.”

Your PF Community

Woman laying down reading

Visit the Pulmonary Fibrosis News forums to connect with others in the PF community.

View Forums