Level of transparency in clinical studies

There has been a recent shake-up in the field of publication of clinical study results: EU and US organizations, even pharmaceutical companies, have all implemented or announced plans to expand their publishing practices.

Ein Mitarbeiter eines forschenden Pharma-Unternehmens sichtet Zulassungsunterlagen. So viele Ordner sind nötig, um alle Seiten des Zulassungsantrags für ein einziges neues Medikament zu fassen.However, the communications about this sometimes appear contradictory. This is because it is not simply about "the study results": in fact, clinical studies and their results can be reported at quite different levels of detail.

The following table list the types of study information, their level of detail, and how the procedure works in matters of transparency. It applies to clinical studies in Phases II, III and IV, which are conducted on patients (as opposed to studies in Phase Iwhich are typically conducted on healthy volunteers; it also does not apply to non-interventional studies, for which again other publishing rules apply).

DocumentGives information on
(typical length)
Previous statusFuture status
Trial registrationDrugs, sponsor, study design, sites, parameters, etc., no results
(1-2 pages)
Mandatory for some years now; e.g. in clinicaltrials.gov or clinicaltrialsregister.euunchanged
Summary of results for experts, onlineDrugs, sponsor, study design, parameters, efficacy and tolerability in all study arms
(2 - 20 pages)
Summaries must be published for studies with EU participation [4] since approx. 2004 and for studies with US participation since approx. December 2007 (start date). This is required by the EU and the USA. The clinicaltrialsregister.eu register currently contains 12,683 summaries and clinicaltrials.gov 26,897 summaries (as at 06.15.2017)unchanged
Summary of results for laypersons, onlineDrugs, sponsor, study design, parameters, efficacy and tolerability in all study arms
(1-2 pages)
Short overview of the summaries of EPARs on the EMA website [1]until 2019 at the latest [2], then on a new, publicly accessible EMA database
Publication in scientific journal [3]Same as for the summary for experts, with additional discussion of results (5-10 pages)
(5-10 pages)
desirable, not mandatoryunchanged
Clinical Report (also called "Clinical Study Report")Same but in yet more detail
(1,000 pages)
Study reports on drugs, whose EU authorization procedure started from the beginning (first authorizations) and middle of 2015 (authorization extensions), are published after completion of the procedure: clinicaldata.ema .europa.euthe collection grows
Raw study data (= patient level data)Complete treatment files, pseudonymized
(10,000 pages)
Disseminated if requested but no publicationunchanged

[1] EPAR = European Public Assessment Report; EMA document which explains the reasons for the approval of every EMA-approved medicine, available here.

[2] The original plan was to implement this statutory obligation at EU level by mid-2016; however, there were delays in the setting up of the necessary web portal and the associated database by the EMA. The web portal and the database are legally regulated by the Clinical Trials Regulation, which makes provision for adjusting the deadline in the case of a delay.

[3] With peer review

[4] In the case of studies on minors, also without EU participation