Clinical trial transparency

Scientists at work

The ABPI is a strong advocate for transparency in clinical trial information.  Following a change to the ABPI Code of Practice in 2012, companies are obliged to publish all clinical trial results within one year of marketing authorisation and publically register new clinical trials within 21 days of the first patient being enrolled. This is in line with the International Federation of Pharmaceutical Manufacturers and Associations Code of Practice.

Indeed, the pharmaceutical industry has been and continues to be committed to evolving and addressing the issues relating to transparency in clinical research. The first joint position relating to clinical trial transparency was launched in 2005 and was last updated in 2009.

It is important to recognise that research is a truly global activity, with the UK supplying less than 2% of patients to global clinical trials. As part of a global industry, we are actively engaging with our European and international counterparts, as well as many other stakeholders, to input into on-going discussions around clinical trial transparency.

Our commitment to transparency

In February 2013 the ABPI committed to providing a disclosure toolkit for companies to help them meet their requirement for trial transparency under the Code of Practice.

This toolkit provides good practice guidelines, disclosure checklists and a template standard operating procedure for pharmaceutical companies. These materials will be updated regularly in line with changes to international regulatory requirements.

Clinical trial disclosure toolkit

The information provided in this toolkit for companies is provided in good faith, and every reasonable effort is made to ensure that it is accurate. The toolkit is not intended and should not be construed as regulatory or legal advice. The ABPI cannot in any circumstances accept responsibility for any errors or omissions and users should satisfy themselves as to their legal obligations.

The disclosure toolkit consists of the following 11 documents:

Folder 1

  1. Points to consider when managing disclosure – this document provides an introduction to the tasks and requirements companies should consider when planning disclosure activities.
  2. Form R100 – this template form provides a framework for assigning named individuals to the SOP tasks.
  3. Template standard operating procedure (SOP) on clinical trial registry, results posting and publications – this document provides a template SOP covering the processes for posting clinical trial information on relevant portals and registries.
  4. Process flow maps – this presentation captures template process flow maps to map companies disclosure processes  relating to trial registration and results disclosure.

Folder 2

  1. Process checklist: Trial registration – this checklist (PDF and Excel version available) outlines the key process steps to be assessed against a disclosure SOP to ensure oversight of disclosure activities undertaken around trial registration.
  2. Process checklist: Results disclosure – this checklist (PDF and Excel version available) outlines the key process steps to be assessed against a disclosure SOP to ensure oversight of disclosure activities undertaken around disclosure of results.

Folder 3

  1. Task checklist: Trial registration – this checklist (PDF and Excel version available) outlines the key tasks to be assessed against a disclosure SOP to ensure oversight of disclosure activities undertaken around trial registration.
  2. Task checklist: Results disclosure – this checklist (PDF and Excel version available) outlines the key tasks to be assessed against a disclosure SOP, to ensure oversight of disclosure activities undertaken around disclosure of results

Folder 4

  1. Self-training and Q&A materials: Template SOP – this presentation contains training materials and frequently asked questions on the template SOP document.
  2. Self-training and Q&A materials: Checklists –  this presentation contains training materials and frequently asked questions to support use of the four checklists.
  3. Useful links – this documents contains useful links to key regulatory and government publications relating to transparency and disclosure commitments.

Download the ABPI clinical trial disclosure toolkit here

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