Introduction to Clinical Trial Disclosure

June 5, 2015 Francine Lane

Are you new to disclosure and don’t know where to start?  This is the first in a series of “Back to Basics” on clinical trial disclosure and is intended to help navigate the challenging world of disclosure.

Disclosure in clinical trials is becoming relevant to more and varied organizations.  Once the domain of large pharmaceutical and biotech companies, smaller biopharma, academic, and research organizations are paying close attention to disclosure.  Read on to find out why.

Clinical_Trial_Scrabble

What is disclosure?

Clinical trials disclosure is providing clinical trial data to a registry.  A registry can be described as a website that is accessible to the public and free of charge that contains a standard set of data describing a clinical trial.  Registries may also contain trial results information, but that is not a requirement to be a registry.

  1. Study Registration:  provide information about the study from the study protocol.

This includes information such as who is conducting the trial, where is it being conducted, and what is being studied.  A more comprehensive list of information can be found at the World Health Organization (WHO) website.  This data set is required for any registry that aspires to be a WHO Primary Registry.

  1. Results Disclosure:  provide information about the results of the study. 

A subset of results data that typically includes how the subjects move through the study (subject disposition or participant flow), the baseline characteristics of the participants (demographics), outcomes or endpoints, adverse events, and limitations of the study.  Other data may be collected, but these cover the standard data collected for the major registries.

  1. Data Requests:  provide information, upon request, on detailed results data.

This is a rather new addition to the disclosure/transparency realm and includes requests by researchers, journal editors, or other interested parties for study data that has traditionally not been available to the public.  These requests are typically for redacted Clinical Study Reports (CSRs), anonymized patient data, or other supporting documents that can be used for further analysis or research.  This information is typically provided directly to the requestor, rather than included in a registry available to the public.

How are studies registered?

Studies can be registered in one of three ways

  1. Sponsors or responsible parties (investigators) submit the data themselves.

This occurs on sites such as ClinicalTrials.gov.  Sponsors or investigators create an account and are responsible for registering their own studies in a timely manner.

Results are provided directly by the sponsor or responsible party (e.g. the principal investigator).

  1. Registration is done by the organization approving the trial. 

This is how studies are registered on the EU Clinical Trials Register.  A Clinical Trial Application (CTA) is provided to one or more National Competent Authorities (NCA) in Europe to approve the execution of the trial in a specific country.  The NCA in turn, imports part of the CTA into a database and once the study is approved, it is released to the registry for publication on the website.  The sponsor or investigator does not control the process after submitting the CTA.

This method does not disclose results, even if the registry is initially populated by another organization (such as the NCA).  Results must be entered by the sponsor or responsible party.

  1. Feed from another registry

There are some registries that get some or all of their data from a different registry.  The Registry of Patient Registries (ROPR) gets some information from ClinicalTrials.gov that can be augmented by the sponsor or investigator.  Another example is the WHO International Clinical Trials Registry Platform (ICTRP).  While not a “registry” in itself the ICTRP consolidates feeds from various data providers to populate its database.

Results may or may not be included in a registry populated by a feed depending on the information included by the data provider as well as what the target registry displays.

Want to find out more?

Request a free copy of the Introduction to Clinical Trial Disclosure whitepaper.

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