ABPI clinical-trial disclosure toolkit

Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.

This was initiated in February, when the ABPI unveiled a new set of measures to help improve compliance with data-transparency clauses in its Code of Practice.

As per the code, all member businesses must register a clinical trial within 21 days of the first patient being admitted to the trial and post the results within a year of the novel drug being granted a marketing authorization.

The disclosure toolkit would be updated regularly to depict changes in international regulatory requirements like the new data transparency policy scheduled for a launch by the European Medicines Agency , comprises 11 documents including disclosure checklists, good practice guidelines and a template standard-operating procedure (SOP).

What are the minimum requirements?

It is not intended as regulatory or legal solution. A Points to Consider document provided as part of the toolkit notes that country laws, the International Federation of Pharmaceutical Manufacturers and Associations’ Joint Position paper and the ABPI Code of Practice give the framework and define minimum requirements for disclosure of clinical-trial information. But it adds a sponsor company might decide to go beyond the minimum requirements. Some businesses have chosen to release information about all clinical researches, regardless of phase, design or participant type, while others at least disclose information about all patient trials either interventional and non-interventional and regardless of the phase of the trial.

To mentions, any such decision is endorsed by senior management who would own the company disclosure policy,as stated by the the document.

Patient-level data

The considerable points also address critical issues for example third-party access to patient-level data, which calls for a robust process to remove any information that could contribute to the re-personalization of clinical-trial data.

If a business decide to share patient-level data, the document points out, it should clarify and define in a Disclosure SOP concerns such as :

  • Explanation of patient-level data

  • Whether requests from any entity either commercial or not will be considered.

  • What criteria the requesting party needs to content in terms of evidence of capability and availability of good analysis practice.

  • What the requester requires to submit with respect to an analysis, quality-control and publication plans.

  • Controls to assure adequate anonymity of patient level data and removal of other sensitive data.

  • Timeliness for providing response and satisfying data requests.

Strong advocate

The ABPI is a strong supporter for transparency in clinical research information, as stated by Stephen Whitehead, the association’s chief executive.

He added that earlier this year they committed to provide a clinical trial disclosure toolkit to businesses and he’s delighted that this is now available on their website for any company usage. Whitehead added that as part of a global industry and with the UK contributing fewer than 2% of all patients recruited to clinical researches worldwide, they are actively engaging with their European and international counterparts to input into ongoing discussions around clinical research transparency.

Clinical data transparency is an important issue for all.

  • It important to ensure that any research practices are transparent, responsible, and fully compliant with applicable laws, regulations and guidelines.

  • It needs dedicated and trained staff for purposes of timely registration of clinical trials, communication of trial results, and publication of all sponsored trials and research studies.

  • A proper collaboration with external medical researchers to advance clinical research and enhance public health.

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