For the pharmaceutical industry, it’s another part of the business that cries out for change: the complex and costly human studies involved in developing new medicines.
Pfizer, the world’s largest drug maker, is preparing to test a "virtual’’ clinical trial which would allow patients to participate from their homes, eliminating the time and expense of traveling to medical schools or other study sites. For now, it’s just an experiment, according to Craig Lipset, head of Pfizer’s clinical innovation efforts. "It’s about trying to reinvent the way we’re capturing data,’’ Lipset said, "and the way we’re conducting clinical trials.’’
The ability for patients to log into a website and report data electronically creates the possibility of reducing expenses and eliminating some of the inconvenience and demanding requirements, according to people familiar with the clinical trial process. Still, some experts think drug studies require patients and the data they generate for researchers to be more closely monitored than the "virtual’’ trials allow.
Clinical trials are critical to drug development, but they are also onerous. On average, they can take eight years to complete, require thousands of people and millions of dollars. They can also involve testing sites scattered across the country or around the world. Heavily regulated and complicated by science as well as statistics, the studies are required by federal regulators to prove that a prospective drug works effectively and safely.
Pfizer isn’t the only company interested in finding new ways to make the trials less cumbersome while still meeting the standards set by federal regulators. Merck and Johnson & Johnson are also exploring ways to improve and modernize the clinical trial process. "The way clinical trials are right now, they are definitely cumbersome,’’ said Sunanda Gaur, director of the Pediatric Clinical Research Center at Robert Wood Johnson Medical School. "It’s a very difficult, time-consuming experience for (study volunteers), but it’s necessary.’’
Pfizer, which has its headquarters in New York City and operations in several locations in New Jersey, is currently recruiting individuals to participate in an experiment that will involve an approved medicine for overactive bladder. "They’re testing on an approved drug because it’s the process that they’re really testing,’’ Lipset said. Pfizer’s experiment will allow patients to remain at home rather than requiring them to travel to a medical school or some other clinical trial site. The patients will be supplied with cellphones and provided with Internet access so they can access a special website where data — in this case, urine frequency, urgency and side effects — will be collected and managed by Pfizer’s internal team.
Lipset said the patients will have to submit some data at the start of the trial, make about four "virtual’’ visits by providing data to Pfizer via the web site. During the 16-week "virtual’’ clinical trial, patients will also be able to speak with a member of the study staff at any time. Even the recruitment phase is testing new ground. Lipsky said Pfizer is tapping social media outlets and bloggers to recruit volunteer patients. The goal is to gather 600 women with overactive bladders who are willing to participate in the remote trials.
Jeff Sherman, a managing partner at BioEndpoint Consulting in Lawrenceville, is doubtful that the virtual model will become widely used in the industry. Clinical trials, he said, are not taken lightly by the Food and Drug Administration. Regulators would have to be closely involved in designing and setting up an actual virtual drug study and still, some drug makers would likely consider it to be to risky to rely on self-reported data, he said. "If you ask researchers, the term clinical trial has a very significant meaning, they’re carefully designed, they’re blinded so the results can’t be skewed,’’ he said. "It’s a profession in and of itself.’’
Lipset isn’t surprised by Sherman’s reaction. "Many people pointed to the Food and Drug Administration and said that would be the biggest hurdle,’’ Lipset said. But it wasn’t. The agency, he said, has supported the industry’s efforts to explore possible changes. It’s no wonder why. The late stage of a clinical trial — in industry jargon, it is known as Phase 3 — is generally considered the largest and most expensive part of a study. The Phase 3 stage of a drug study can cost as much as $70 million to complete, according to Sherman.
Gaur, who runs pediatric clinical research center at Robert Wood Johnson Medical School, said she also doesn’t see the self-reporting process being tested by Pfizer as a complete replacement to conventional studies. "It could be an element,’’ she added, "depending on the type of drug being studied.’’ But even Lipset doesn’t view "virtual’’ studies as a panacea.
Digitalizing clinical trials isn’t likely to make recruitment for drug studies suddenly so much easier. Much of the public still doesn’t know a lot about drug studies and how they work. Even for its virtual trial experiment, Lipset said, Pfizer is looking for a diverse group of women with overactive bladder — all of whom have to feel comfortable using gadgets and sharing information over the Internet. It’s not an easy task. "It’s still not for every patient,’’ he said. "They’re out there. It’s just a matter of getting them to understand what we’re doing.’’
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