Clinical data disclosure and transparency

The pharmaceutical industry has put greater focus on posting results of clinical trials for public disclosure. Data transparency is an important aspect of clinical research as it enables evidence-based decision making in medicine. Moreover, clinical data disclosure and transparency is of utmost importance due to legal obligations and compliance factors associated with data disclosure.

EU Regulations

The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The timing of application is yet to be determined due to initial technical issues and the COVID pandemic.

The Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will consist of the centralized EU portal and database for clinical trials as foreseen by the Regulation. EMA will set up and maintain the CTIS, in collaboration with Member States and the European Commission.

This may possibly change the format of the EudraCT XML files which are posted along with the EudraCT reports. Additionally, this may result in updates to the current tools/programs that are being used to generate EudraCT XML files.

Impact of BREXIT on EUDRACT posting

The European Commission published a notice to stakeholders on September 6th, 2018 informing pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including submission of clinical trial information to EudraCT.

The notice stated that protocol-related information from clinical trials conducted in the UK will no longer have to be submitted to EudraCT except when the trial is part of an agreed Pediatric Investigation Plan and the UK is the only country in which the protocol has been submitted.

Moreover, results of completed clinical trials conducted in the UK before the withdrawal date must still be submitted to EudraCT if the reporting of these results is due.

Challenges in the pandemic situation

With the COVID-19 pandemic taking its toll on public health and disrupting almost all industries, pharmaceutical industry has had to work in tandem for faster development of COVID-19 vaccines and treatments, expediting the need for quicker disclosure of results for all studies. This coupled with the ongoing trend of acquisitions and mergers in the pharmaceutical industry, with clinical trials data of the involved companies being handled by multiple vendors/contract research organizations (CROs). This, at times, has resulted in incorrect data reporting or discrepancies in the clinical study report (CSR) as well. All of this puts a strain on regulatory compliance deadlines for disclosure.

How Accenture took up the challenge

Accenture has supported clients in various ways to ensure smooth data disclosure while meeting submission deadlines. We have worked towards and achieved consensus amongst different stakeholders (Disclosure Team, Medical Writers, Statisticians and Programmers) on the clinical data and results analyzed.

Recently, we helped a client troubleshoot submission related issues by leveraging client’s legacy and historical data after mapping it as per CDSIC standards.

Value delivered

Accenture services evolve in line with the ever-changing Clinical Data Disclosure and Transparency requirements and we continue to assist clients in meeting regulatory deadlines, despite the pandemic situation.

We have three guiding principles to ensure smooth and seamless delivery for Clinical Data Disclosure and Transparency:

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Accountability

Support end to end reports and XML generation for EudraCT posting, faster deliverable submissions and handling critical deliverables for regulatory.

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Quality

Managing 100% quality for the deliverables, ensure internal validation and peer review are performed for the submissions including urgent submissions.

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Flexibility

Offering flexible work hours to the team so that maximum overlap provided in case of any queries to be addressed by the client team. 

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Despite changing requirements from regulatory, Accenture continues to up-skill and deliver with quality adding value to the client experience.