Over the past decade, global expansion in clinical trials has been significant. According to Clinical trials.gov, nearly half (47 percent) of trials are conducted completely outside the United States. While these global clinical trials are supporting faster and broader research, there are inherent challenges to running a clinical trial in multiple countries, including language barriers and recruitment limitations. Most importantly, the industry is finally recognizing that limitations exist in global transparency.
Global Disclosure Adds Complexities
When executing a trial within a single country, a trial sponsor is only responsible for disclosure according to that country’s requirements. The difficulty in global disclosure is when a trial sponsor has studies running in multiple countries, such as in the U.S., several European countries, and China. To publish data and remain compliant, the sponsor must now deal with each country’s registry individually. This can be burdensome for a trial sponsor because each registry requires data at slightly different points in time during the study and requires slightly different data sets.
Additionally, there is a lack of standardization when it comes to the way the data is captured and reported. When conducting multiple trials internationally, sponsors utilize local affiliates for on-the-ground, in-country support. The challenge with this is that, while each respective affiliate team can be fully compliant with individual, local requirements, its disclosed data may not align well with the data publicly available in other countries. This can add unnecessary complexities for a sponsor running a single trial in multiple regions.
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Bridging the Gap in Global Transparency
To ensure globally consistent trial transparency, the industry needs global, central management of transparency efforts. There needs to be a central place where trial sponsors and their local affiliates are tracking what is being disclosed, when it’s being disclosed, and where it’s being disclosed, so that sponsors can have a general oversight of the trial. Today, most sponsors maintain their disclosure structures differently. Many think, “Our local representative is responsible for disclosure, so I don’t need to worry about it locally,” but this approach is not sustainable. If transparency advocates, and the industry at large, took a hard look at global disclosure, it would be much easier to identify the discrepancies between each individual country’s reporting requirements and begin to create alignment.
Global management of clinical trial disclosure is desperately needed. To achieve this, consider establishing a transparency steering committee. This committee can oversee the harmonization among operations, regulatory affairs, and trial data publication. Such a committee would provide an objective oversight and understanding at any given time of how to overcome silos and manage and track trial data disclosure across an organization.
Great strides have been made in the name of clinical trial transparency, but there is still much left to be done. The implementation of data regulations and an enforcing oversight committee can have a great impact and encourage many trial sponsors to become more transparent with their trials.
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Thomas Wicks is chief strategy officer for TrialScope. He has more than 17 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management.
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