Interview: Clinical Trial Transparency Is Improving, Particularly Among Larger Companies
Concerns over clinical trial transparency have been around for some time, but things are improving, particularly here in the United States as more companies embrace the idea.
Thomas Wicks, chief strategy officer of New Jersey-based TrialScope, said transparency has picked up over the past few years, particularly as large pharma companies have begun to release information about their own clinical efforts. For example, two years ago, Janssen released its first annual transparency report that highlights its pricing and marketing practices, patient access programs and costs of the company’s clinical trials. Wicks said the idea of clinical trial transparency is shifting beyond mere compliance and into “more of a true idea of transparency and data sharing beyond what’s required by law.
Being transparent with clinical trial data is something that proponents, such as Wicks and others, believe is a benefit to science. As an example, if data is published, good or bad, future researchers will know not to follow the same path, which will free them up to pursue other avenues of potential research, Wicks said.
“Part of the promise of transparency is that, if we went after a particular target in the clinic, someone won’t do that again and waste resources and put people at risk,” he said.
So far, the larger companies are embracing the transparency trend, but Wicks noted that many smaller companies are still a bit hit and miss, largely due to the size of the company and its financial resources, not as a willful disregard of the idea of transparency.
But, there is a bit of a silver lining when it comes to smaller companies. As c-suite-level executives leave larger companies to helm smaller biotechs and startups, Wicks said they bring a culture of transparency with them.
“There’s been a cultural shift in transparency over the past 10 years,” he said.
Wicks added that the more transparent are, the more public goodwill they can generate. Providing information to the healthcare ecosystem that can be accessed by patients and participants… so that information is more readily available, is the right way to go forward, he said.
In the United States, Wicks said, there has been a lot of focus on the idea of clinical trial transparency, which has improved compliance. In Europe, there are still some pockets of concern. But, Wicks said things “are beginning to shift in Europe.” He said the European Medicines Agency has sent out to companies across the continent regarding the disclosing of results. In November, a U.K. government report revealed about half of all clinical trials there are not published, which raised concerns over research integrity and risks to human health. The report decried the failure of researchers to disclose trial results regardless of the outcome. Also, the report said that a lack of published data is not only a “threat to research integrity,” but also increases risks to individuals, which is a point that Wicks has made to BioSpace on a number of occasions.
As 2019 rolls on, Wicks said pharm executives are looking beyond transparency compliance and looking at ways to leverage the data. He noted that TrialScope has several products that can benefit companies looking to do this. In September, the company launched TrialScope Engage. Described as a transparency and health literacy management solution. TrialScope Engage enables clinical trial sponsors to engage with patients, healthcare professionals, researchers and the public via a dedicated clinical trial informational website. Wicks noted that pharma companies are looking to communicate their research in more meaningful ways to benefit patients and providers, which TrialScope Engage can do.
At the end of January, TrialScope forged a strategic partnership with Vivli, a nonprofit organization focused on sharing of clinical trial data through its innovative platform. The collaboration will offer sponsors and researchers access to the most complete solution for disclosure and data sharing. By working with Vivli, TrialScope said it can provide its customers with the most comprehensive approach to disclosure and data sharing in the market.