Defining the Boundaries in Clinical Trial Data Sharing

How much of your structured data do you want to see published when you submit a clinical trial authorization request in the EU? And just as pertinently, how much information from other trials do you think you should be allowed to see?

It's a live question. The EU’s 2014 Clinical Trials Regulation has brought in unprecedented levels of transparency and accessibility to clinical trials information, and the boundaries of exactly what should be in the public domain, and when, are now being drawn. And this requires a very refined balancing act. As the EU admits as it tries to set the limits, even while "delivering high levels of transparency, the disclosure rules must ensure that personal data are protected… and sponsors’ legitimate economic interests are protected by avoiding disclosure of information considered commercially confidential."

Access to some information might seem uncontroversial—trial title; trial population; maybe trial design information, including inclusion/exclusion criteria; even endpoints. The same might be assumed to apply to details of the products used, the active substance, strength, pharmaceutical form, and posology. Similarly, information about trial status (start, restart, end of trial) or recruitment status (start, restart, end of recruitment), or even the principal investigator's contact details might not be considered to be setting the bar for access too low.

What about details of the trial sponsor, including sponsor contact point and third parties involved? Or of requests for information (and responses) raised as intermediate steps in the evaluation of a clinical trial application? And should there be any limits on outsiders learning about temporary halts, including when they are safety related. Should information on serious breaches be off-limits or not? The same question applies to when urgent safety measures are necessary, or when unexpected events, or when assessments are carried out by regulatory authorities on notifications. And should the same candor apply to inspection reports relating to non-EU countries inspection reports?

In an attempt to head off accusations of excessive secrecy or excessive openness, the EU is asking everyone for their views. It has launched a public consultation with a series of specific questions relating to these data fields—and also to how far people think it should be providing access to documents too.¹ What it has in mind here range from the banality of the cover letter of an application to the more delicate issue of clinical study reports or Intermediate data analysis results, with in between such documents as the sponsor statement of data regulation compliance, the protocol, any scientific advice, the investigator's brochure, details of the trial products safety and efficacy, the informed consent form, and the suitability of investigators and of the trial facilities.

Everyone can take part in the survey and give a yes/no answer relating to each of the fields and each of the documents. The EU wants to get it right. It says access to this sort ofinformation is important "to enable candor of patients in clinical trials, to build public trust, and to share knowledge on trial design, conduct, and results [that] should invigorate clinical research in the European Union and facilitate access to medicines to patients." The broad outlines in the clinical trials regulation now have to be given a clearer focus, it says, since the legislation's disclosure rules for the database where information to the public will be provided define only "high level principles."

Based on experience using the EU's new clinical trial information system (CTIS), "or your perspective as a clinical trial stakeholder, please express your views," says the survey. "Of the structured data and documents provided in CTIS for publication, which ones would you consider critically important for publication at the time of decision of a trial application and during the trial life cycle"—followed by an extensive list of options.

But everyone who wants to give their views will have to move fast. The survey opened only in May, and will close at the end of June.

Reference

1. https://ec.europa.eu/eusurvey/runner/TransparencyRulesPublicConsultationCTIS