As promised earlier this year, the Association of the British Pharmaceutical Industry (ABPI) has launched a clinical-trial disclosure toolkit to help its member companies comply with transparency requirements for information from or about clinical studies.
The initiative was flagged up in February, when the ABPI unveiled a new set of measures to help boost compliance with data-transparency clauses in its Code of Practice.
Under the Code, all member companies must register a clinical trial within 21 days of the first patient being admitted to the study, and post the results within one year of the associated drug being granted a marketing authorisation.
The disclosure toolkit, which will be updated regularly to reflect changes in international regulatory requirements (e.g., the new data transparency policy scheduled for introduction by the European Medicines Agency next year), comprises 11 documents including good practice guidelines, disclosure checklists and a template standard-operating procedure (SOP).
It is not intended as regulatory or legal advice. A Points to Consider document provided as part of the toolkit notes that country laws, the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) Joint Position paper and the ABPI Code of Practice “provide the framework and define minimum requirements” for disclosure of clinical-trial information.
However, it adds, a sponsor company “may decide to go beyond the minimum requirements”. Some companies, for example, have chosen to release information about all clinical trials, regardless of phase, design or participant type, while others “at least disclose information about all patient trials (interventional and non-interventional, and regardless of the phase of the trial)”.
It is important that any such decision is endorsed by senior management, “who will ‘own’ the company disclosure policy”, the document stresses.
The Points to Consider also address crucial issues such as third-party access to patient-level data, which calls for “a robust process to remove any information that could contribute to the re-personalisation of clinical-trial data”.
If a company does decide to share patient-level data, the document points out, it should clarify and define in a Disclosure SOP issues such as:
How patient-level data are defined.
Whether requests from any entity – commercial or non-commercial – will be considered.
What criteria the requesting party needs to satisfy in terms of evidence of capability and available ‘good analysis practice’.
What the requester needs to submit with respect to an analysis, quality-control and publication plan.
Controls to assure adequate anonymisation of patient level data and removal of other sensitive data.
Timelines for responding to and satisfying data requests.
The ABPI is “a strong advocate for transparency in clinical-trial information”, said the association’s chief executive, Stephen Whitehead.
“Earlier this year we committed to providing a clinical trial disclosure toolkit to companies and I am delighted that this is now available on our website for any company to use.”
As part of a global industry, and with the UK supplying fewer than 2% of all patients recruited to clinical trials worldwide, “we are actively engaging with our European and international counterparts, as well as many other stakeholders, to input into ongoing discussions around clinical trial transparency”, Whitehead added.
The toolkit is available to download from the ABPI website at http://www.abpi.org.uk/our-work/library/guidelines/Pages/ABPI-disclosure-toolkit.aspx.