OR WAIT null SECS
With global regulatory changes happening quickly and often, there is concern that sponsors need more robust systems to keep pace and have a global disclosure strategy in place.
Not a day goes by that somewhere, someone takes issue with the lack of transparency in pharma, usually targeted around the dearth of clinical trial results available in the required, global-reaching regulatory authority databases. While most fuel the negative public perception machine around pharma, there are professionals dedicated to making sure that pharma, at a minimum comply, and at a maximum exceed those regulatory requirements. Those professionals will gather later this month at CBI’s Clinical Trial Transparency Event. And many of like-minded thought-leaders gathered last month at TrialScope’s first Clinical Trial Transparency Leadership Forum.
TrialScope, a provider of clinical trial transparency and compliance solutions, has been creating products in disclosure since 2008. Mike Forgash, TrialScope’s CEO, told Applied Clinical Trials that even with the company’s foundation on transparency, “you never know enough” and points to the revolving door of regulatory changes, and the trend of global trials, requiring a company have a global disclosure strategy.
In this Forum, Forgash noted the Forum was open to both its product customers and non-customers and provided a very fruitful discussion. Thomas Wicks, Chief Strategy Officer at TrialScope, presented at the Forum and served as moderator. He shared with us some of the discussions that came out of the discussion.
“What needs to be disclosed is changing,” said Wicks. “For example, the U.S. is shortening timeframes for disclosure but the existing legacy systems may not be up to do that quickly.” In addition, he noted that the scope of data is increasing, especially in products that are not yet approved. That requires a real mental shift for industry as well as a need to address confidential information areas. “The regulatory changes are happening quickly and there is concern about the ability of the systems to adjust.”
Overall, says Wicks, organizations are meeting regulatory requirements. The current discussion or disconnect is “What must we do vs. what ought we do and how to balance that effort,” he said. Organizations such as AllTrials, the Cochrane Group, the World Medical Organization, and WHO have expectations that go beyond the current law in the U.S. and EU. For example, WHO expects posting of data in all clinical trials done in humans, including Phase Ia and Phase Ib, which currently is not a requirement in the United States.
Wicks said, “Some companies are more aggressive than others and are committed to posting all Phase I through IV, as well as observational trial data, within 12 months of study completion. All aim to comply with regulation, and an increasing number want to go beyond the limits of the law.”
In regard to global disclosure, many countries have some kind of requirement, but they tend to differ on the scope of data or disclosure timing. Wrap this around the fact that localized personnel handle the task of meeting these local requirements. The lack of centralized or harmonized systems means that the trial sponsors don’t quickly know if the way the study is described is the same in the United States, versus Italy versus Hong Kong.
So what can organizations do to ensure they are in compliance, both internally and externally? Metrics. Wicks says that key metrics that could be considered are what percent of protocols are submitted on time; what percent of protocols are on time and then go beyond minimum requirements? How many results are in per regulation, and then how many are past due. The key to getting that data lies within the individual organization’s system and ability to collect. For some, particularly those using TrialScope’s product, that may prove easier. For others, with disparate data systems, that process could take a number of weeks.
Wicks noted that there is more difficulty for small- to mid-size pharma and academic research centers-those who conduct lower numbers of trials per year-to navigate the cumbersome regulatory landscape. “They are looking for the most efficient process,” explained Wicks. “But there are no established best practices. Through organizations like DIA, companies are facilitating that.” But Wicks believes that smaller companies, thinking they can use a CTMS to potentially manage the timelines, will be disappointed. “That’s not a clinical registry system and it’s not intended for that.”
Thomas Wicks will present “Assessing the Implications of the New EU Clinical Trials Regulation on Preparing and Submitting Clinical Trial Applications” on day one of CBI’s Clinical Data Disclosure and Transparency conference.
Lisa Henderson is editorial director of Applied Clinical Trials.