A group of House Democrats led by Congressman Edward Markey (D-Mass.) on Aug. 2, 2012 introduced the Trial and Experimental Studies Transparency (TEST) Act of 2012 (H.R. 6272), legislation that “updates and expands the clinical trial registry data bank—ClinicalTrials.gov—with stronger reporting requirements,” according to a press release dated that same day (1).
This proposed legislation is yet another step to address the increasing demand for greater transparency of clinical trial information. As we have seen in the past, the impetus for change in disclosure legislation can usually be traced back to a demand from the public and not-for-profit organizations.
The TEST Act is meant to close clinical trial loopholes created by legislation and initiatives from the past 30-years and bring certainty and transparency to life-saving research studies. One of these loopholes results in registered trials never reporting study results (e.g., including safety data), putting future human participants at risk if a different company decides to develop the same or similar drug. TEST would achieve a fuller accountability of clinical trial information by expanding requirements to include the following:
Require all interventional (including phase 1) biomedical studies on humans to be registered with the database before the participant is enrolled in the trial
- Key impact:
- Addition of phase 1 studies which are currently not posted (Note: Sponsors conduct an average of five Phase 1 studies per drug, depending on the type of product, orphan designation, and review status (2)).
- Postings of inform consent forms and full protocol documents, including all dated amendments to the initial version of such documents, as approved by IRB/committees
- Key impact:
- Risk associated with exposing proprietary information contained within documents
- Additional operational support to facilitate the document management
- Strengthen reporting requirements so that results from all covered trials (including both investigational and marketed drugs and devices) are posted on the database within one year of the completion of the trial; delays are allowed for an additional year for interventions that have never before been approved for any use
- Key impact: Reporting results of investigational products is a significant expansion of existing requirements of only reporting marketed drug/devices
- Instruct the Secretary of HHS to undergo a rule-making to require foreign trials that are used to support an application for marketing in the U.S. to comply with disclosure requirements
- Key impact: This is a significant addition since 80% of the drugs entering the US market in 2008 were clinically tested overseas
- Ensure enforcement of law by instructing NIH and the FDA to provide a report to Congress regarding the implementation and compliance with the database requirements
- Key impact: Non-compliance can get costly with up to $10,000/day penalties (3)
- Key impact:
According to an article published in the January 2012 issue of the BMJ (“Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study”), a review of trials registered on ClinicalTrials.gov in 2009 and covered by the 2007 FDA Amendments Act (“FDAAA”) showed that of the 738 trials classified as subject to mandatory reporting, only 163 (22%) had reported results. Through the new regulations proposed in the TEST Act, and the enforcement to follow, compliance and the quality, timing and completeness of clinical disclosure information will surely be tested. And the increased demand for transparency is not just limited to the US, with 18 mandatory country registries existing worldwide and a growing number with pending legislation.
Q. How can sponsors of clinical trials ensure compliance (e.g., mitigating risk) with current posting requirements, while managing the increase demand for transparency in both the US and worldwide?
A. As the demand for transparency has increased incrementally throughout the years, it is critical that operations in the following areas are put in place to offset the increase in risk:
- People: Need a mix of project managers to facilitate workflow and medical writers to author summaries.
- Processes: Ensure an integrated workflow that can encompass tracking, assessments, document management, summarization, review & approval, quality control, data transfer, query exchange, site/status updates…and re-use of information for international reporting. We recommend a centralized team to manage workflow and oversee all process, systems, quality and compliance.
- System: Can serve as a centralized and definitive (“single source”) catalogue of your summary information, with functionality to facilitate all workflow.
Lastly, as legislation continues to evolve, it is important to know what future areas of disclosure are being debated as future legislation could follow; here is a list of items under consideration:
- Posting of non-technical (e.g., ICHe3) summaries (source: NIH Rulemaking)
- Final study reports & raw datasets (source: British Medical Journal)
- Patient recruitment targets and performance of all investigators (source: PloS Medicine)
Consider a services partner to help you manage your clinical trial disclosure reporting needs!
- http://www.diahome.org/productfiles/8357/diaj_11725.pdf – (file moved or longer available)