Could you start with an introduction to TrialScope?

At the highest level, TrialScope has two priorities: one is to help trial sponsors comply with disclosure regulations and internal transparency policies across the globe, and the other is to support the relationship between sponsors and patients. We work with a variety of clinical trial sponsors, including seven of the top ten pharmaceutical companies on the compliance front, and over one third of trials posted by clinicaltrials.gov are posted by our customers.

Traditionally, we have worked with the bigger top 30 or 40 pharmaceutical companies, because they have the largest volume of work and our flagship system presents a great advantage in helping them to be more efficient. The smaller companies tended to have more manual processes, which were adequate as long as the perspective was not global and executive management did not expect ongoing visibility into compliance. The perception of disclosure can vary, but all life science entities, from academic institutions to biotechnology companies and big pharma, are obliged to disclose data on clinical trials involving humans. The challenge in managing disclosure is that simply complying with transparency regulations may suffice to meet legal obligations, but does not address the focus of transparency advocates on the ethics of disclosure and obligations to the patients.

What are the major gaps between the law and what might be considered best practice?

The requirement in the United States is that sponsors must post protocols for phase two, three and four trials that were active on or after September 27, 2007.  There are certain qualifications to this requirement, for example, specific interventions are excluded, but that is in essence the status quo. Results must then be disclosed within 12 months of the primary completion date, which is the last visit of the last patient for purposes of data collection on the primary outcome of the study.  Again, there are exceptions to this timeline, in part based on the approval status of the product and on the sponsor filing a certification of delay or good cause extension.

However, transparency advocates would want to know, for example, why phase one studies are not being disclosed, because they also involve studies in humans. The World Medical Association sets an ethical standard for studies in the Helsinki Accords, including a policy requiring that all studies with humans must be registered publicly and results must be disclosed. Many companies refer to the Helsinki Accords in their corporate ethics statement, but do not consistently register protocols or disclose results for all studies with human participants.  For example, the U.S. and EU laws do not require the disclosure of clinical information for all Phase 1 trials, which means that datas for many of these trials are not publicly available, though according to the Helsinki Accords these should be disclosed.  Transparency advocates and an increasing number of forward-thinking trial sponsors promote the disclosure of data for all interventional trials to advance science, avoid the unnecessary repetition of studies, and to honor the commitment of trial participants.

How does TrialScope’s PharmaCM platform help clients to manage the risk and disclosure surrounding clinical trials?

The data volume is very large, particularly for large sponsors managing hundreds or even thousands of trials. PharmaCM allows companies to take data out of their source systems, such as clinical trial management systems and clinical results systems, and import them into an environment in which the data can be edited to the specific requirements for disclosure and then routed for approval. Our system assists with data accuracy and pushes this information out to the registries.  It is designed to assist with timelines and ensure compliance with the law. Our system can actually translate data from clinicaltrials.gov to fit the European requirements and vice versa.  The software service is hosted by us, so customers do not have to develop their own solution.

Our focus has historically been assisting larger sponsors to comply with regulations in the United States and Europe.  To assist sponsors of any size conducting trials in multiple countries we are now also launching our new product, ATLAS Global Compliance, which helps companies manage global disclosure compliance across different sites and markets. There are at least 25 regions in which data must be proactively posted, and others in which data is made publicly available by the regulatory authorities. This new solution is designed to provide global visibility into the transparency requirements across these regions, calculating upcoming disclosure dates and assessing past compliance.

TrialScope CONVERT is also a useful tool to drive greater efficiency. Could you provide some further insight into this platform?

Whilst we are a commercial vendor, with tools that organizations can subscribe to, we also conduct research that we share freely. One capability of our system is to translate the results that sponsors have prepared for clinicaltrials.gov to the standard required by the European platform, EudraCT. We have made this results translation freely available to the sponsor community as a public service. Anecdotally, we have been told that CONVERT has saved sponsors between six and eight hours per study.

How does the idea of patient centricity play into TrialScope’s results portal?

One of the realities of disclosure is that the results data have so far not been directly useful to patients because they are available in a scientific format and clinical language that is not easily understood by everyone. To address this issue, the Europe Union has established a requirement that results of clinical trials must be made available to trial participants as a plain-language summary that can be easily understood. While this requirement is specific to trials conducted in the EU, many sponsors are choosing to make plain-language summaries available for all their trials, in recognition of trial participants and the patient communities.  We created the Trial Results Summaries portal with the intent that any individual that has partaken in a trial can find such a summary explaining the outcome of their trial.

What is the strategy for TrialScope going forward?

We aim to be a trusted and irreplaceable partner to all clinical trial sponsors globally by providing a single source of relevant clinical information to trial registries and participants, focusing on regulatory compliance and patient-centered transparency.