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The FDA Amendment Act is on its way toward implementation at years’ end. We reveal the facts on clinical trial disclosure for compliance with these new requirements.
You may have heard that an amendment to Title VIII of the Food and Drug Administration Amendment Act has passed final review, and will be in effect on January 18, 2017. The legislation requires timely reporting by industry and academia of clinical trial results. Industry has not paid close attention because it’s taken so long to implement.
But that’s about to change. Failure to comply will cost drug trial sponsors tens of thousands of dollars a day. It’s vital to know the full facts when it comes to clinical trial disclosure in order to avoid steep fines for failing to comply with new reporting requirements.
1) Myth: There’s no down side to the transparency that comes from reporting as much human clinical data as possibleFact: Drug industry innovation may be inhibited by requirements to share key finding if industry loses the ability to protect innovation based on findings that are sometimes unexpected and provide new clues for the manufacturer that it may not wish to share for competitive reasons.1 Another limit to transparency is the need to protect patient health information.
2) Myth: Now that regulations are in place requiring disclosure of clinical trial results, we should expect to see results published in a timely manner.Fact: Only 13.4% of trials reported summary results within 12 months after trial completion.2,3,4 That said, there are valid reasons to withhold data for more than 12 months and those reasons are included in the law. Most non-compliance analysis takes a strict definition of the law in to account – where a study must have EITHER results or a certificate of delay within 12 months. However, most companies understand that a certificate of delay is not necessary if there are legally acceptable reasons to delay results disclosure. Regardless, with just 13 percent of trials reporting results, it’s clear that there will be continued calls for trial sponsors to disclose results sooner.
3) Myth: Major medical journals have fixed the problem of inaccurate reporting of clinical trial results.Fact: Misleading transparency statements and inaccessible protocols continue to make possible publication of incomplete, misleading, and outcome switching data.5,64) Myth: Clinical trial sponsors understand reporting requirements, and generally are in agreement on what should be published and when it’s expected.Fact: National health authorities and legislators in approximately 30 countries around the world have established trial transparency regulations, though the scope and timing of disclosure is generally not well harmonized across these requirements. Even established legislation such as the FDA Amendments Act of 2007 is still subject to differing interpretation by trial sponsors, which contributes to the reported non-compliance with legal and ethical standards in studies such at the Good Pharma Scorecard.7 For example, there is no general agreement whether it is mandatory to submit a certificate of delay or good cause extension when a sponsor postpones results disclosure for more than 12 months after the primary completion date.
Another area in which those researching trial disclosure practices disagree with the policies of many sponsors, is the scope of transparency beyond strict compliance with country-specific regulations. For example, the FDA does not require the disclosure of protocol information or trial results related to Phase I trials, while many organizations including the World Health Organization (WHO) and the World Medical Association (WMA) expect the disclosure of information on all trials in humans, which includes Phase I studies. The WMA has enshrined these requirements in the Declaration of Helsinki since 2008 and while many trial sponsors align their ethical principles with the Declaration of Helsinki, this has not yet led to a consistent disclosure of data on Phase I studies by these sponsors.
5) Myth: When it comes to clinical trial data reporting, “best practices” for trial sponsors have been established.Fact: While trial sponsors commit to meeting their legal disclosure obligations, there are no industry best practices for meeting these obligations, in terms of the scope of disclosure, the preferred organizational roles and responsibilities and stakeholders, the standard operating processes or the disclosure technology. In 2015, TrialScope ran an initial Disclosure Maturity Assessment, establishing an initial set of industry transparency benchmarks, which confirmed that there is a broad range of approaches to trial disclosure. In comparing the 2015 assessment with earlier surveys certain trends are developing:
Thomas Wicks is Chief Operating Officer for TrialScope