Pfizer announced, last week, that it was partnering with technology firm Private Access to launch an online social network to help patients find clinical trials more easily.

According to Pfizer, a top complaint from physicians is difficulty in matching patients with trials. “Finding volunteers has been a big issue for anyone conducting a clinical trial. Not just pharma companies, but any researcher conducting a trial,” said Kristen E. Neese, director, worldwide communications, Pfizer.

The problem is twofold. One the one hand, patients are concerned about sharing their personal health information; on the other hand, there hasn’t been a central location for patients to look for clinical trials and have their information matched with the most appropriate trial for them.

Pfizer Senior Strategy Director Usama Malik told Pharm Exec on Wednesday that the difficulty finding patients is causing drugs to take longer to get to trials, and in turn, raising costs.

“The clinical trials industry is highly fragmented,” Malik said. “Pharma companies, traditionally, haven’t worked in unison to increase value. They don’t speak to each other about the holistic opportunity for patients, providers, and pharma [to work together].

The new site will offer best-of-kind services including:
• Education and awareness for specific conditions and clinical trials
• Trial recruitment via patient posts and traditional research requests
• Some form of social community

Since 2002, Pfizer has posted every clinical trial its been involved with on NIH’s trial bulleting, but the drug giant wanted to establish a network that offers a more personal experience for the user. “This builds on that by creating more of a social networking site where patients can share their information and find trials that meet their specific needs,” said Neese.

For example, a diabetes sufferer can go to clinicaltrials.gov, type “diabetes,” and get thousands of protocol listings. Sorting through the different criteria is daunting, said Neese. The new site will allow patients to determine if they want to share their private information with researchers who are looking for patients that meet their specific criteria.

Much as a person would be asked to befriend someone on Facebook, a patient could be alerted that a researcher is looking for patients with diabetes; the patient will then be asked if they would like to share their information with this researcher.

“We have a long term vision for this site that includes not only Pfizer clinical trials, but all clinical trials,” Neese says. “We want this to be a tool that is going to be useful to patients. For it to work, it has to include more than just Pfizer.”

The site is scheduled to launch within the next year.

But consider this. The first ideas for GPP were formed a decade ago, and now the time is right for GPP2: the new, revised Good Publication Practice.

Why now? Pharma publication practice is a hot potato. Purported cases of publication-related ‘misconduct’ or alleged misdemeanors reflected in high profile clinical publications come to light, it seems, every month. More often than not big pharma is the target, like this in the Wall Street Journal, like this in Annals of Internal Medicine.

And then FDAAA turned up the heat. Results posting in 12 months means pharma supported clinical trials will be out there in the public domain quick, and posted in some detail on clinicaltrials.gov.

Clinical publications had better keep up. A peer reviewed analysis of clinical trial data published in a journal and out there when the same data is posted on clinicaltrials.gov means that interpretation is no longer just anyone’s (or everyone’s?) business. And, yes, clinical publications had better shape up too: it’s not good news when stories hit the press about undisclosed conflicts of interest in clinical papers, or suppression of less than favorable data.

GPP2 will deliver best practice guidance for the post-FDAAA era (the ‘post-posting’ era?). It will capture the evolution in best publication practice seen over the last decade, drawing on newest guidance (new Declaration of Helsinki, new ICMJE, and more). As always, GPP will encourage responsible and ethical publication practice. It will help those involved in the publication and communication of clinical information funded by companies to keep up with the rapidly changing environment.

Working with support from the International Society for Medical Publication Professionals, the GPP2 Steering Committee will open its Global Consultation on the first draft of the new guidelines late in 2008. You can expect GPP2 to offer advice about preparing for and executing GPP for clinical trial papers as well as, for example, for special cases like abstracts and presentations, post hoc analysis, meta-analysis, and reviews. Get in touch with Chris Graf to get involved.

Disclosures: Chris Graf is co-chair, ISMPP Standards & Best Practices Committee. He is Associate Editorial Director at Wiley-Blackwell. He is Publisher of International Journal of Clinical Practice. He owns no stocks or shares.