BioNews Clinical Moving to Bring Trials Into ‘Continuum’ of MG Care

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by Grace Frank |

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BioNews Clinical | Myasthenia Gravis News | Illustration of line chart labelled clinical trials

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 Myasthenia Gravis 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’s mission is to change that, helping to advance the clinical research 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.

Its Sept. 13 launch in myasthenia gravis (MG) is a first step in this process: Clinical is sending a survey to readers of this site that will help to determine their interest in such research and being part of it. Similar surveys in other orphan and chronic disorders are likely to follow.

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“MG is a rare and debilitating disease that affects 20 in 100,000 people in the United States alone,” Debidda said. “Patients often go misdiagnosed for years, and there is significant heterogeneity in disease progression patterns. Because of its low prevalence and because of the physical strain imposed by visit schedules that are not always built to accommodate patients’ daily challenges, recruitment of MG patients for research studies of any kind is extremely slow.”

Currently, 19 MG trials are underway across the U.S., and actively looking for more than 2,300 patients to take part, she added — “a lot of ongoing research that will hopefully result in the approval of new treatments for MG.”

By connecting “our community of over 10,000 MG patients to those clinical trials, we see a unique opportunity to accelerate the discovery of new therapies,” Debidda said.

Pilot runs began earlier this month to connect people with multiple sclerosis (MS) and idiopathic pulmonary fibrosis who, through previous surveys, expressed an interest in relevant trials.

Ongoing studies that are recruiting through BioNews Clinical will, for now, be those based in the U.S.

Gradually, the service will open to trials in all the rare and chronic disease communities that its parent company, BioNews Services (also this website’s publisher), 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 eventually be included because, especially in rare diseases, sufficient numbers of patients are difficult to recruit in tightly defined locations, and size is necessary to support statistical — reproducible — confidence in trial results.

Patients identified through surveys run by BioNews Clinical are selectively matched with trials brought to it by sponsors — whether pharmaceutical companies or independent researchers and institutes — by Debidda and Liza Bernstein, a patient engagement specialist.

Typically, clinical studies recruit through 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 two million people together across the diseases it covers, she said. “The communities already existed. The dialogue was initiated. … BioNews Clinical is the aftermath of a reality that is alive and thriving.”

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

Debidda sees three main issues as barriers to patient participation: basic awareness of relevant trials underway; study protocols that too often are not updated, overly restrictive, and difficult 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 need to drive to the clinical site, given the disease’s physical and cognitive toll.

Debidda also draws on insights voiced by people with rare and chronic diseases 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.”

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

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

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 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 surveys, and pilot efforts in recruiting for 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.”

2021 Myasthenia Gravis Survey Results

BioNews Survey Infographic

Myasthenia Gravis News conducted a survey from Feb. 11-March 28 to gain greater insight into the characteristics of the MG community and disease management. Results of the survey have now been published. Click on the image to view the infographic, and click here to read the story.