From The Editor | August 12, 2016

Clinical News Roundup: Can Clinical Trials On Pets Help People?

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

clinical news

Can clinical trials on dogs and cats actually help to treat diseases in humans? Science reports researchers at the University of Pennsylvania School of Veterinary Medicine hope they will. Researchers are developing new therapies for humans by testing them in sick dogs and cats, rather than in mice or lab rats. One study hoping to provide a breakthrough in cancer currently involves 13 canines. The number of these trials is currently booming, with hundreds conducted in just the past decade.

The rationale is that pets are a better model for human illnesses than rodents. They live in the same environments, sometimes eat the same food, and get many of the same diseases as their human counterparts. They could also hold the key to developing new therapies for humans at a fraction of the normal cost, while yielding new medicines for pets themselves.

But others question whether these studies will really have an impact on human health. "It's a very interesting idea, and it all sounds very nice," says Larry Baker, an oncologist at the University of Michigan, and the former chairman of one of the largest human clinical trial organizations in the United States. "But this field has yet to prove itself."

Pet trials are now underway for cancer, brain tumors, seizures, dry eyes, and osteoarthritis. There are also hints that pet trials may be edging into the mainstream. Last summer, nearly 200 veterinarians and physicians met for the first time with funders, government regulators, and representatives from the pharmaceutical industry in Washington, D.C., to discuss how these studies could better contribute to human health.

In 2015, New Haven, Connecticut–based Kolltan Pharmaceuticals announced that its experimental antibody drug KTN0158 dramatically shrank a common skin tumor in dogs, prompting it to begin clinical trials in humans. "The dog trial had a dramatic impact on our strategy to develop this product for people," says the company's president, Jerry McMahon.

NEJM Doubles Down On Resistance To Data Sharing

In January, the New England Journal of Medicine (NEJM) warned data sharing could lead to “research parasites,” or researchers hoping to gain unearned glory off the backs of hard-working colleagues. The article earned scorn from the scientific community, which felt the analysis was petty, short-sighted, and accused the authors of being more concerned about personal gain than the expansion of knowledge.

But now Stat News is reporting the NEJM has doubled down on its view, publishing a new editorial from a group of more than 200 researchers in more than 30 countries. They argue that science is moving too hastily in the direction of open data, which could be a headlong and thoughtless dash that could retard progress and jeopardize human health.

Stat reports the essay takes aim at a recent proposal by the International Committee of Medical Journal Editors (ICMJE) to require that data from any randomized controlled trial (RCT) — the gold standard of clinical studies — be made fully available within six months of publication.

The new editorial argues against that proposal, noting that although researchers who conduct trials would still get initial credit for their work, they might lose the chance to publish secondary papers and other analyses they deserve. “A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data,” the researchers wrote. “The original investigators almost always intend to undertake additional analyses of the data and explore new hypotheses. Once the investigators who have conducted the trial no longer have exclusive access to the data, they will effectively be competing with people who have not contributed to the substantial efforts and often years of work required to conduct the trial.”

J&J Partners With Yale To Share Data

While some still dispute the logic of sharing clinical data, at least one sponsor company appears to be all in. Johnson & Johnson (J&J) is partnering with the Yale Open Data Access (YODA) Project on a pioneering data-sharing model that began in 2014. Under the agreement, YODA (led out of the Yale School of Medicine) serves as an independent body to review requests from investigators and physicians seeking access to clinical trial data. YODA will also make final decisions on data sharing.

Now the NEJM has published a perspectives article, “The Yale Open Data Access (YODA) Project—A Mechanism for Data Sharing,” that discusses the partnership. The article is co-authored by Joanne Waldstreicher, M.D., chief medical officer for J&J and Harlan M. Krumholz, M.D., SM, leader of the YODA Project and director of the Center for Outcomes Research and Evaluation.

“Within the first year, we received 29 requests for data, and all were subsequently approved,” says Waldstreicher. “Our J&J companies also prepared 123 trials for use as resources by researchers worldwide. We are aware of two papers in development from data we’ve shared through the YODA project, and look forward to seeing more in the future.”

Waldstreicher notes as environments continue to evolve she is encouraged by the fact that more and more stakeholders are adopting policies to allow for greater access to clinical trial data. A number of approaches are being pursued by others, and data from these programs will help determine how best to collectively share data.

BIO President Defends Orphan Drug Act

In response to a critical article in The Washington Post accusing the pharma industry of straying from the initial intentions of the Orphan Drug Act, BioPharmaDIVE reports BIO President Jim Greenwood has fought back in an op-ed.

The article notes that since the law was passed in 1983, pharma companies have increasingly sought to develop and market drugs for so-called orphan diseases. The law was intended to act as a spur for drug development in rare diseases. However, some contend the process has now become a way for pharma companies to charge excessively high prices for drugs while enjoying a longer period of market exclusivity and tax credits.

Greenwood argues the Orphan Drug Act has been a success, citing the fact that 400 orphan drugs have been approved since the Act's inception, compared with 34 prior to its enactment. "According to the study, there would have been one-third fewer orphan drugs on the market treating patients with rare diseases over the last 30 years without the incentives found in the Orphan Drug Act," he writes. "By any measure, the Orphan Drug Act has been a resounding success and given hope to millions of families. Let’s not harm the system that has made this success possible."

Quintiles And DaVita Clinical Research Announce Alliance

Quintiles, the world’s largest provider of product development and integrated healthcare services, and DaVita Clinical Research, a wholly-owned subsidiary of DaVita HealthCare Partners Inc., have announced a global strategic alliance. The alliance combines DaVita’s clinical care and expansive footprint of research sites with Quintiles’ operational delivery and therapeutic expertise in clinical trials.

“Through this alliance with DaVita Clinical Research, we will have the power to provide biopharmaceutical customers with nephrology expertise and global delivery capabilities to truly advance clinical research,” said Jeanne Hecht, SVP and global head, Site and Patient Networks at Quintiles. “Our aim is to align our processes to reduce cycle times and accelerate clinical trial execution. Moreover, we will be able to alleviate the burden on patients participating in renal disease trials by incorporating clinical research into clinical care.”

DaVita Clinical Research is part of DaVita Healthcare Partners, a leading provider of kidney care as well as one of the largest U.S. healthcare providers, providing care to more than one million patients who may be available for potential trial enrollment. DaVita Clinical Research brings to this alliance data-driven trial feasibility expertise, trial sites in Europe and Latin America, its deep clinical knowledge of renal patients as well as an established research infrastructure with DaVita dialysis facilities and 30 years’ experience conducting clinical trials across therapeutic areas.

“This alliance allows novel approaches to clinical development and clinical trial execution, specifically in site identification, participant enrollment, and study design,” said Amy Young, VP and general manager of DaVita Clinical Research. “We are excited about the opportunities this affords our organizations to provide innovative solutions to the biopharmaceutical industry and the participants we serve.”