According to the FDAAA TrialsTracker, 60.5 percent of clinical trial results in the United States are published. With nearly 40 percent of sponsors non-compliant and a recent FDA guidance on civil money penalties, the need to educate the pharmaceutical industry on the importance of transparency is very real.
To answer some growing transparency questions, we turn to Zach Weingarden, Product Solutions Manager at TrialAssure.
What are some of the most common issues affecting organizations with transparency in clinical trials?
With most clinical trial registries, the rules can be complicated, having no single definitive source. When conducting a large, global clinical trial, registering those clinical trials may need to occur in multiple places. This all depends on which countries that the sponsor has sites in and where the drug is marketed.
On top of that, deadlines, data requirements, and processes can vary significantly across registries, with some requiring a working knowledge of the local language. These factors make it challenging to centralize the transparency process, but without doing that manually or through proven systems, oversight capabilities can get lost.
Resourcing can become a challenge as well. At study completion, a sponsor’s focus is on the next steps in the drug’s development plan. Whether that means publishing, planning subsequent studies, or working on a submission package, I have seen transparency take a back seat many times.
Even with a dedicated transparency team, input is needed from the study teams to ensure that the information to be disclosed is accurate. Adding to this, redaction of certain clinical documents is becoming more and more mandatory, which means an anonymization process must occur.
Do these same issues exist at the university level? How does it differ?
These transparency issues are much more pronounced in universities and colleges throughout the world. In fact, a recent article pointed out that only 9 percent of completed clinical trials at universities have posted their trial results. These institutions tend to have more pressure to publish in a recognized journal, and generally have fewer resources to dedicate to clinical trial disclosure or anonymization initiatives.
Additionally, there are many other registries in the U.S. for specific conditions, such as cancer, that usually carry their own requirements tied to public funding. So, for academic institutions, these types of registries are usually more important than the international ones.
For the government registries, these often already limited disclosure teams need to navigate a complex network of researchers and investigators to validate information. Oftentimes, these individuals are no longer involved. Overall, it can be uncertain whose responsibility it is to complete transparency work at the university level.
What do you think the transparency landscape in the pharmaceutical industry will look like in 10 years?
I think that the industry will care more about the utility of information, as opposed to just the availability like we do today. The pharmaceutical industry as a whole will likely take a more standardized approach to clinical trial design, meaning more consistency with outcome measures and endpoints across clinical trials.
Standardization allows the results from studies conducted by varying sponsors will be sharable without a huge analytical burden. From a patient perspective, I also expect that clinical trial registries will be more intuitive and will really help to drive recruitment. It has the potential to be easier to see if a patient qualifies for an ongoing clinical trial, or to find results from a trial that they participated in.
Lastly, I believe that in the future all the global registries will be integrated on a single platform that is searchable in any language.