Clinical trial sponsors are largely unaware of the conflict that arises when dealing with the new, increasingly Internet savvy e-patient who is highly motivated, well educated, self-advocating, and self-informing, says Bonnie Brescia, of BBK Worldwide. “But the Internet is undermining that whole model.” Read more.

©2012 An Inconvenient Woman. All Rights Reserved.

This article appeared in  eCliniqua, an ePublication that reports on the medical trial process. I thought Inconvenient Woman readers would find it a helpful research resource. eCliniqua is a great publication for those who wish to follow the trial design process, and the regulatory considerations of a well-designed medical trial. The publication archive and resource sections are particularly helpful.

I’m new to Twitter technology. I have to admit when it first came out, I didn’t understand the power of the tool. I find it telling that Big Pharma and the related medical-industry pilot fish were early adapters. It will be interesting to follow companies like Applied Informatics as it moves patient recruitment for clinical trials onto social media sites like Twitter.

By Deb Borfitz

Yet another patient recruitment tool has just been released by New York-based Applied Informatics. But this one is a “do-it-yourself” platform that moves the search for clinical trials onto social media sites like Twitter. It also allows would-be subjects with a personal health record (PHR) in Microsoft HealthVault or Google Health to import the information in lieu of filling out an online pre-screening form to be matched for trials.

“Eighty percent of consumers who are online are searching for health information,” says Sharib Khan, co-founder of the new TrialX platform. As many as two million of them are looking specifically for clinical trials or new disease treatments. They frequently discover sites like ClinicalTrials.gov, the massive registry of the NIH, but can quickly get overwhelmed trying to sort through the listings to find a few potentially suitable trials.

As an alternative, they can now send a QuTweet (request) to TrialX from their Twitter account and within minutes receive a targeted response with a URL link to a list of trials appropriate to their query, says Khan. Once there, visitors can further refine the list by inputting or importing information from their PHR inclusive of their age, gender, location, and medical condition. With one or two clicks, they can also email the investigator to learn more about the trial or schedule a screening visit.

TrialX is likewise designed to “empower” investigators who lack the budget for newspaper and radio ad campaigns, the time to field a lot of “false positive” calls, and the know-how to develop their own trials website, says Khan. TrialX gives them a single place to create a profile of their site and trials, receive legitimate leads, communicate directly with those prospects, and get performance reports on the resulting activity – all for between $99 and $299 per month per trial. The fee excludes marketing of their trials on Google, triggered by specific keyword searches, which can cost as little as $1 a day.

According to the 2009 Deloitte Survey of Health Care Consumers, only about 9% of people today have an electronic PHR but 42% are interested in establishing one. So TrialX leverages an emerging technology to make the search for trials a more consumer-centric endeavor. Trials have a lot of complex qualifying criteria which, without an importable PHR, put the onus on patients to understand and remember the particulars of their condition or medications they’re taking, says Khan.

Admittedly, many people—including about three-quarters of all cancer patients—don’t know enough about trials to even be searching for one, says Khan. To help address the information gap, TrialX has a few community features that were first previewed at a Health 2.0 Conference in Boston last week. Patients can now go to TrialX to ask questions about clinical trials in general or a specific trial. Starting next week, those who have participated in a trial can also share their experience at the site.

Meanwhile, partnerships are being established with several “top-name” hospitals that will apply a customized version of TrialX to trials happening on their campus, says Khan. Disease-specific web sites, most immediately one devoted to rare medical conditions, are likewise expected to partner with TrialX to display a subset of trials. Applied Informatics was also recently invited to build TrialX on top of the PHR platform of Indivo, heretofore unavailable to external systems.

Although TrialX has yet to be formally marketed, each day it is receiving hundreds of unique visits and an exchange of three to four dozen emails between investigators and patients, says Khan. It has matched a “few thousand” users to trials since its beta launch last October. In the near future, TrialX will start tracking how many of those matches translate into enrolled patient.

©2012 An Inconvenient Woman. All Rights Reserved.

Medical imaging allows researchers to see the effect of a new drug more rapidly than possible when relying on traditional clinical endpoints. It plays an important role in an increasing number of clinical trials and offers sponsor companies the possibility of decreasing both time and cost in getting new pharmaceutical products
to market.

Sponsor companies increasingly depend on imaging to help them make go/no-go decisions about the products they are developing, to provide surrogate endpoints in clinical trials and to support claims about a new drug’s efficacy and safety.

Medical imaging is an increasingly important factor in the successful conduct of many clinical studies, experts claim. In addition, there has been a rise in the development of imaging core labs, which centralize quality control and assessment of images. During the past three years, these vendors have become an increasingly integral part of the clinical trial process.

PAREXEL’s Bio/Pharmaceutical R&D Statistical
Sourcebook 2008/2009

Get your copy of the leading compendium of pharma/biotech R&D trend data and market intelligence!

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©2012 An Inconvenient Woman. All Rights Reserved.

eCliniqua offers PodCasts, WebCasts, White Papers and much more. Their ‘data-rich’ site is one of my primary research resources for an objective review of clinical trial process and results.

March 2, 2009 | A growing number of online social networking sites are assembling groups around particular disease types as a way of simulating interest in clinical trials and the data they’re collecting on members, according to Matthew Holt, founder and author of The Health Care Blog and co-founder of an annual Health 2.0 conference. “Some sites are talking about [crafting] business plans to help recruit clinical trial participants.”

It’s a recycled idea, disbanded by Harris Interactive a year or two ago. A patient-to-trial matchmaking service was also tried and discontinued by Veritas Medicine. These earlier approaches failed for a number of reasons, including the fact that “many steps in the recruitment and retention process relied upon other players outside the control of the matchmaker companies,” says Kenneth Getz, chairman of the Center for Information and Study on Clinical Research Participation.

Many patients were also disappointed to find a “highly limited listing” of clinical trial options and were “uncomfortable divulging personal information to for-profit companies,” says Getz. Moreover, low consumer awareness of clinical trials made it difficult to broadly reach sufficient numbers of study volunteers. “Ultimately, the per-patient cost of online matchmaking couldn’t justify the investment.”

Brian_Loew
Brian Loew
New social networking sites, “riding the wave of user-initiated online interaction,” hold more promise, says Getz. But it remains to be seen if they can successfully attract study volunteers across a variety of clinical research studies, given that awareness and trust in trials is still low and social networking sites have yet to develop the ideal business model. “Is the value in their reach or in the data they are collecting on community members?” Study sponsors and clinical research organizations will “determine whether the return-on-investment is there” over the next couple of years, he adds.

Inspire, created four years ago specifically to accelerate recruitment via social networking, is confidently giving it a shot. Inspire’s approach is to let social networking serve as “a mechanism for attachment,” says CEO Brian Loew. “You can’t create a community just about clinical trials.” Inspire can deliver “high quality patients,” screened based on a protocol’s inclusion and exclusion criteria, because it has a pre-existing relationship with members who have volunteered to be trial participants.

The first step was to build online communities around a particular disease or condition, which Inspire has done in partnership with more than three dozen non-profit health associations, says Loew. The trial recruitment service didn’t get added until last year and Inspire already has four contracts in place, two of which are with a top-five company. The contracts are for an osteoporosis and arthritis trial as well as two lung cancer studies.

“The trials are underway right now and the early indications are good,” says Loew. “For one of the [lung cancer] studies, we already have a community with ten times the number of members who meet the initial inclusion criteria.”

To the delight of trial sponsors, Inspire also offers a “quality assurance” service whereby trial participants are surveyed about their satisfaction with the investigative site, says Loew. Responses get reported, in aggregate, to companies.

Legally speaking, the fact that Inspire owns and operates the communities assuages industry’s liability concerns regarding conversations about off-label use of their products and adverse events, says Loew.

PatientsLikeMe—focused on five chronic-illness categories, including amyotrophic lateral sclerosis (ALS)—takes a different recruitment approach that is also winning industry fans. This no-advertising venue efficiently targets “those who are both eligible for and interested in information about clinical trials,” says president and co-founder Ben Heywood.

The U.S. Medical Outsourcing Group at Novartis partnered with PatientsLikeMe for a pilot multiple sclerosis (MS) clinical trial awareness program launched last May to enhance recruitment efforts for the FTY720 FREEDOMS II trial, according to a company spokesperson. The pilot consisted of a monthly awareness email sent to MS patient members, with the aim of having them visit the institutional review board- (IRB-) approved website (MSClinicalTrials.com) and be prescreened to determine potential eligibility. The pilot also included a FTY trial awareness webpage on the PatientsLikeMe site that included IRB-approved copy and links to MSClinicalTrials.com, eligibility screener, and us.novartis.com. The experience was “very positive,” the spokesperson adds. “Increased enrollment in the FTY study was not a primary driver for the pilot program, but rather a pleasant and well-received result.”

Study Enhancement

Most intriguing to PatientsLikeMe is “the suggestion by industry to use our platform to create a micro-community for patients participating in clinical trials,” says Heywood. “The goal would be to capture real-world data that supplements information between site visits. Additional safety, tolerability, and perceived efficacy data can help inform marketing and research teams in preparation for regulatory submission. This could ultimately lead to more accurate labeling and safer treatments for patients.”

PatientsLikeMe offers its trial-sponsoring partners a clinical trial awareness package, which might include aggregated data about patients in the community they’re targeting, says Heywood. “We are also in discussions with pharma about collaborating to supplement trial data they collect with patient outcome information.” PatientsLikeMe can also tell its partners about how their approved treatments are being used in the real world.

Interestingly, PatientsLikeMe initiated the first “patient-driven, real-world natural experiment” to learn if lithium arrests the progression of ALS as suggested by a February 2008 article in PNAS (Proceedings of the National Academy of Sciences). The experiment used validated outcome scales to quantify the patient experience on lithium while monitoring side effects and blood levels, says Heywood, allowing the company to amass “the largest population of ALS patients that has ever been assembled for a study of this kind from which to analyze data.”

Patients often can’t or don’t want to wait the years it takes for evidence to emerge from a formal clinical trial. In “merely months,” and for “very little money,” the study on PatientsLikeMe produced enough information to analyze, says Heywood. These types of experiments can provide “credible direction as to when a clinical trial should be conducted. As a result, patients will have a direct voice into what types of research deserve attention and significant investment.”

An Expanding Field

Online marketer Alliance Health launched its first social networking site, DiabeticConnect, last June to promote clinical trials and to date 5% of its more than 17,000 registered members have opted to be notified of trial opportunities relevant to them, says CEO Stead Burwell. On behalf of a half dozen specialized recruitment agencies, Alliance Health also drives traffic to trial screeners via email, newsletters, and online advertisements. But the trial matching service is three times more effective than other types of interactive channels in terms of successful screens, he adds. This year, Alliance Health plans to launch a new networking site every four weeks, including ones for sleep disorders, obesity, chronic pain, and heart disease.

Inclinix has learned firsthand that social networking sites can be highly effective and affordable recruitment venues, says Chief Marketing Officer Chris Sleat. “Many sponsors fear bloggers will turn against their trial, but they’ll blog positive about [a company] as long as [it is] open and honest.”

Among the sites favored by Inclinix are Twitter (a collection of blogs), Reddit, Diggit, Craig’s List, YouTube, Facebook, and MySpace, plus multiple European sites. Some of the others fall short when it comes to driving traffic to their content and then giving visitors a reason to return, says Sleat.

For well over a year now, patient recruitment firm MediciGlobal also has been successfully using social networking sites like Facebook, MySpace, and Twitter, according to president and CEO Liz Moench.

Meanwhile, more than 1,000 clinical trials researchers and health care professionals are collaborating around specific studies on the VisionTree Optimal Care (VTOC) Network. The no-ad site, launched late last year, allows physicians to “interact, refer, and discuss current issues and clinical trials” at no charge, says Adam Hawkins, director of technology. It integrates with Twitter and YouTube to share blog posts, files, and links between members. “We are working with partners who have a large patient population to allow for outreach and recruitment into clinical trials through the VTOC Network. You will see some of these in coming months.”

©2012 An Inconvenient Woman. All Rights Reserved.