It wasn’t that long ago that patients just wandered away after a clinical trial wrapped up, never learning the results of the trial, never knowing whether or not their participation made any difference.

Patients didn’t like it, but that was just the way it was.

Ninety percent of patients reported that they wanted to know the results of the clinical trial they partcipated in. However, as late as 2012, 91% reported never hearing back from study staff or the sponsor. And 68% said that if they weren’t informed of trial results, they wouldn’t participate in future trials.

Times have changed, though. Fast.

In the last two to three years, spurred on by the 2013 revision to the Declaration of Helsinki that highlighted the need to disseminate research results, the concept of being transparent with participants about trial results has become popular. So popular that the EMA made it law last year, requiring sponsors to publish easy-to-understand summaries of research a year after a study wraps up. U.S.-based sponsors that conduct trials in Europe had to comply, and the concept spread stateside. The HHS also issued a new final rule requiring all researchers to post trial data, no matter a study’s outcome.

TransCelerate recently published guidelines on how to be transparent with clinical trial results in a way that conforms to regulatory standards. Businesses have begun springing up around the concept, with most offering to craft and publish the summaries for sponsors.

This month, a new concept in the reporting of trial results space hit the market. AstraZeneca partnered with TrialScope to launch the Trial Results Summaries Portal, a website that allows sponsors to pay to input their trial results, and trial participants can check to see what became of the trial in which they participated. The site is free for trial participants.

“We spoke directly to patients to understand their needs and to support the development process and we were diligent about incorporating this feedback into the portal,” said Julie Holtzople, clinical trial transparency operations director for AstraZeneca, in a release. “This is why we have invested in this important tool, which we hope will become a central location for studies from many sponsors. Ideally, it is best for patients and the public if they can find trial summary results from across the globe, across companies, across research sites, and in one central place.”

“Disclosing clinical trial information and creating transparency around the data are big steps toward increasing trust between the public and the industry,” said TrialScope CSO Thomas Wicks.

According to Wicks, other companies have their own websites for patients to check back on trial results, but this is the first multi-sponsor portal dedicated to trial results.

It was a bumpy and fast road to get to trial results transparency. “Around 2007, when the push toward transparency started, there was arm twisting,” Wicks remembered. “There was naming and shaming. But now, it’s just a given. Now people like you and me are such active seekers and users of information, it’s unthinkable not to offer them the results of their trial.”
It’s not just the patients that benefit, Wicks said. Sponsors who use services like TrialScope’s can avoid some of the headaches around the transparency movement.

While the FDA can fine researchers $10,000 per day if trials are not registered and results shared on ClinicalTrials.gov, the rule has yet to be strictly enforced. ClinicalTrials.gov has proven not just to be a painful process to those posting results, but a user-unfriendly interface for patients who—if the data for the trial they participated in was  even posted—aren’t able to interpret dense scientific language.

“The way some sponsors have been communicating trial results to patients has been absent a website,” said Wicks. “They write it up and print it out and send it to the clinical research sites, who have to contact the patients and have a conversation. Sites want to be paid, and that’s expensive.”

In addition, sites can lose track of patients after a trial. With the new service, during the patient’s last visit of the trial, the clinical site gives the patient a thank you card containing the URL for the portal, and the patients go home and sign up to get the results emailed to them, said Wicks. As it’s illegal for sponsors to know the identity of people who participated in their trials, the portal provides a de-identifying barrier between the two, just as sites had done.

Wicks said the portal doesn’t use patients’ email addresses for anything other than that purpose. He added that TrialScope may at a later date add an opt in feature for patients to sign up for more information pertinent to their disease state, though.

Currently, said Wicks, the FDA is grappling with pressure to make sure the study summaries out there are not only presented in language that’s easy to understand for people without a scientific background, but are free from promotional language and sales pressure.

Jersey City, N.J.-based TrialScope, which began 10 years ago as part of Intrasphere, does clinical transparency management. TrialScope built the platform that helps pharma companies disclose information on ClinicalTrials.gov, said Wicks. The company manages disclosures for about 30% of industry sponsored clinical trials.

Transparency is key across the industry lately. Last month, Janssen released its first annual transparency report that highlighted its pricing and marketing practices, patient access programs and costs of the company’s clinical trials. And Merck (MRK) published its first “Pricing Action Transparency Report” for 2016.

Thus far, said Wicks, sponsors are excited about the concept and jumping in, while others are taking a wait and see approach.

“It goes beyond what’s even required by regulatory bodies; now it’s more about what participants want, and doing the right thing,” said Wicks. “That’s the push we’re seeing now. It’s an interesting time to be in disclosure.” 

This article was reprinted from Volume 21, Issue 10, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »