PatientsLikeMe Offering Rapid Patient Feedback On Clinical Trial Design

Global online patient network PatientsLikeMe launches a service to inform clinical trial development with retrospective data mining and prospective research using its online patient network.

The PatientsLikeMe global online patient network is introducing a service allowing biopharma research and development teams rapid access to patient data and feedback that could inform the design of clinical trials.

The new service “is a systematic, quantifiable, quantitative source of information that will help people developing trials to make better decisions by listening to patients,” PatientsLikeMe VP for Innovation Paul Wicks said in an interview. The organization is launching the service at the Drug Information Association annual meeting in San Diego June 16.

PatientsLikeMe is a forum where patients connect with others who have the same disease or condition and track and share experiences, generating real-world data about treatment outcomes. The network has more than 250,000 patients trading information on 2,000 diseases or conditions. It was founded in 2004 with an initial focus on neurodegenerative diseases, such as amyotrophic lateral sclerosis, multiple sclerosis and fibromyalgia, and has expanded to other areas since then.

Patient-reported outcomes are becoming increasingly important to regulators and payers looking to establish the benefits of drug treatments. FDA has expressed support for using social media to help validate PROs (Also see "Can Social Media Help Validate Patient-Reported Outcomes? FDA Reviewer Gives “Resounding Yes”" - Pink Sheet, 3 Jun, 2013.). That has prompted the drug industry to investigate operations such as PatientsLikeMe as a source of potentially important information. PatientsLikeMe recently announced a five-year research collaboration with Genentech Inc. (Also see "Genentech Social Media Collaboration Will Focus On Patient Experiences In Cancer" - Pink Sheet, 8 Apr, 2014.). It has also worked on smaller projects with other pharmaceutical firms.

Two Ways Of Gathering Information

Information can be drawn from the network in two general ways, Wicks explained. Researchers can mine the existing database of feedback from patients with a specific disease to learn in a retrospective fashion about what patients are looking for in terms of clinical trials and what negative experiences they might have had in the past. Then, prospective research could be conducted through surveys or by reviewing discussion boards to help find answers to specific questions related to a study protocol in development, he said.

The prospective studies might involve hundreds of participants with the disease or condition of interest, which is on par with the typical observational study on disease prevalence, Wicks noted. In addition, he pointed out, “our studies take less than 30 days to complete, whereas a lot of [observational] studies in the literature take years.”

The rapid turnaround can allow companies to adjust study protocols at the first sign of a problem, he said. “By asking patients to what extent these different factors increase or decrease their interest in participating in a study and getting qualitative information back on why this might be a barrier and what could be done about it, we provide information that can help decision-makers to either change the protocol or to make contingency plans” for protocol amendments down the line, Wicks explained.

“The concept here is that with the patient voice, foresight can be 20/20. You don’t have to go back and Monday-night-quarterback what’s going wrong when your recruitment goals aren’t being met.”

Wicks emphasized the service is designed to address existing concerns with consulting patients at the R&D stage, such as that the process is too cumbersome, legal and privacy issues can slow it down, or that patients will mention an unconfirmed adverse event. “We can monitor for adverse events. We can strip out first-line identifiable information. We can present the aggregated data in a way that is safe for you to see and we can also clean up the qualitative data in a way that is not going to cause any problems,” he maintained.

Patients Motivated To Improve Trials

A recent survey conducted by PatientsLikeMe found patients are “eager” to participate in the development of clinical trials, according to the group. More than 1,600 patients responded to a survey in February and March 2014 regarding their attitudes toward, experiences with and criteria for participating in clinical trials. Results were presented at the DIA meeting in a poster session.

Sixty-two percent of respondents said they had participated in a trial and, of those, 20% were either only “slightly” satisfied or were “not at all” satisfied with their experience. The researchers provided several examples of issues that came up for patients who did not have good experiences.

Reasons for considering leaving the trial included: “The pre-trial screener was burdensome and poorly constructed. It worried me that the quality might be indicative of what might follow”; “I grew tired of taking the injections 8 times a week”; “I found out I’d be travelling every 15 days without reimbursement”; and “It was for insomnia and required me not to take any sleeping aid. I did not think I could participate for six months, especially if on placebo.”

On the other hand, 58% percent of respondents were “extremely” or “very” satisfied with their experience. Eighty-eight percent said they would like to learn more about clinical trials and 80% indicated they would like to take part in a trial within the next 12 months. A strong majority (93%) said they would be willing to help researchers design better trials, according to the study.

The leading factors that went into considering participation in a clinical trial included: “opportunity to improve own health,” “medical bills covered if injured,” “improve health of others,” getting results after trial ended,” and “potential negative impact on health.” Patients responding to the survey had multiple sclerosis (343 patients), Parkinson’s disease (319), fibromyalgia (241), amyotrophic lateral sclerosis (160), type 2 diabetes (158), epilepsy (131) and rheumatoid arthritis (125). Most were women, and the respondents’ mean age was 55.