July 26, 2017 | Recent developments such as the Food and Drug Administration’s Amendments Act and the European Medicines Agency’s mandatory data sharing policies have made it difficult for clinical trial sponsors to ensure they are disclosing information and complying appropriately. TrialScope sees this as especially problematic for small and mid-sized trial sponsors.

TrialScope is a New Jersey-based company that develops software solutions for clinical trial sponsors. Having been in the clinical trial space since 2012, TrialScope has had its fingers on the pulse of trends and habits of trial sponsors.

Thomas Wicks, TrialScope’s Chief Strategy Officer, spoke with Clinical Informatics News writer Benjamin Ross about the challenges small and mid-sized firms face when adhering to the rules and policies of data sharing. Here’s an edited version of the conversation.

Clinical Informatics News: Thomas, what are some examples of transparency in the trial sponsor space? What do you mean by “disclosure” and “transparency”?

Thomas Wicks: It’s challenging because, of course, [when talking about] disclosure and transparency you’re not just in [TrialScope]’s corner of life sciences but with other applications and other users as well. What we’re focused on so far has started since around 2005 with requirements in the international community of medical journal editors, and then the FDA Amendment Act of 2007. There is a requirement that many or almost all intervention trials with humans must be prospectively registered on ClinicalTrials.gov, which is a publicly-accessible website. So all phase II, III, and IV trials must be posted there before patients can enter the trial… There’s also in Europe the European Medical Agency, who, for many years now has made public an extract of the clinical trial application that is submitted to their national authorities. There are around 30 other registries around the world, and in each case the beginning or most important element that kicked it off was the desire to have a listing of all the clinical studies that are bought either locally or elsewhere. That is, sort of a registry of trials. Now in addition, some countries like the United States and European member states have added in a requirement that results also be disclosed when the trial is finished after a certain period of time and then the results are made to the public at least in a summary form.

Those are the core elements of what we call disclosure. That’s been added to over time and so it’s shifted from just disclosure to a broader concept of transparency where pharma companies are now not just adding summaries, but they’re also making data sharing commitments where a much deeper detail of trial data is made available publicly.

How might trial sponsors encounter challenges when trying to comply to transparency or disclosure policies?

When we’re talking about small-, mid-, and large-sized pharma companies, we’re talking about three core issues. One is organizations taking a completely legalistic perspective on trial disclosure. So there are companies that take the perspective of, “We’re going to be compliant to these laws, but no more. That’s all we’re going to do, we’re going to take a purely legal perspective.” Another [issue] is if you have a global organization, not taking a global, wholistic approach to disclosure… There’s no centralized perspective on what’s going on, so taking the decentralized approach causes its own problems, especially for smaller organizations. The third issue is really one looking at it from a lack of systems. [Smaller organizations] just don’t have necessarily the robust data sources that are populated in a high quality and timely fashion.

When we unpack the first one, in our perspective, trial transparency is at its heart about making information of clinical trials available publicly, not only to the research community but also to the public. Over 90 countries have some legal requirements to disclose trial data on at least one of the 30 registries around the world. When organizations take the regulatory requirement approach, they’re missing out on the opportunity to develop relationships with the public. There’s a real loss of opportunity in patient engagement. The larger organizations, in contrast, have recognized that and have already or are in the process of implementing a much more generous understanding of trial transparency.

What is the difference between smaller and larger sponsors?

[The larger companies] are looking at it not just as a “check the box” exercise, but really saying, “This is an opportunity for me to demonstrate my commitment to research, to the community that we serve, and perhaps even gain something back, not just in terms of positive recognition, but furthering the science and having other insights come out of having patients who have been in trials or are looking at them, and feeling good about the commitments they’ve made. So larger companies have recognized that, not just because they must, but because they’re choosing to.

Are there trends you’ve seen reflecting this contrast?

I ran a [survey] where, about two years ago, I got responses from over 50 organizations, and I asked people to classify themselves by the size of their organization. It was very, very clear that smaller organizations are focused on legal compliance and large organizations are focused on a much heavier emphasis on a broader concept of transparency… A large company should be able to tell their chief medical officer where data online from trials are made publicly available, when they were made publicly available, and were they made available in compliance with regulations and company policies. Smaller companies lacking that engagement don’t necessarily have any ability to answer those questions. If they do it becomes an internal struggle where they ask “Oh shoot, what did we do?” That’s not to say that they’re not compliant, but it’s an uncontrolled process.

So larger companies are really ahead of the game, while the smaller companies are essentially playing catch up?

Yes, absolutely. Bigger companies also have resources to do that. In a large organization we have five or ten full-time people working on trial disclosure, whereas with a small company that responsibility may be with just one person, alongside other responsibilities. So there is a sort of resource question as well.

What are some solutions that can help this smaller companies overcome these challenges?

I think the first question is from a strategic perspective. More of the leadership [in these small companies] should ask themselves, “What are we doing to prioritize our relationship with patient communities, trial participants, and their physicians?” It’s our belief that one of the managers will say that in order to prioritize our relationship with [the patients and physicians] we need to communicate more often. I think that is a question that, fundamentally, needs to be asked at the executive level. Executives should also be asking themselves, what is their responsibility in transparency today, and what should it be? With that comes the question of whether or not they believe it’s just a regulatory compliance issue, or are there broader ethical and community implications? … I think fundamentally small to mid-sized companies should elevate the conversation beyond just transparency and disclosure, but into arena of thinking about relationship with [the patients].