Data Transparency working group of PhUSE The European Medicines Agency will be looking at reviving its policy on proactive publishing of clinical study reports, which is currently suspended as the agency copes with huge staff losses on account of Brexit. Policy 0043 – a policy which gave access to EMA’s archived documents – is now limited to use by European Union citizens only. Additionally, excessive workload is said to be the cause for cutbacks, including the suspensions of publishing new data packages as a part of Policy 0070. The article states that this is a major interruption of the important transparency initiatives that need to be continued. World Health Organization (WHO) website, 12 of the world’s largest medical research funding agencies and international organizations pledged to implement policies within 12 months that mandate the registration and public disclosure of results for all trials they fund, co-fund, sponsor, or support. Among the signatories are the two largest private medical research funders in the world, the Gates Foundation and the Wellcome Trust. The announcement comes on the heels of the NIH Final Rule governing ClinicalTrials.gov disclosures, which went into effect in January, and underlines the commitment toward transparency of the international research community. Referencing the 2013 Declaration of Helsinki, Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure will be bringing a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows: Senator introduces legislation to amends Sunshine Act – Policy & Medicine Senator Claire McCaskill proposed the Patient Advocacy Transparency Act of 2018 this week that widens Open Payment reporting and amends the Physician Payment Sunshine Act

This week in transparency news: January 5-11, 2019

Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:

Whitepaper published giving global transparency view – PhUSE  

Last month, the Data Transparency working group of PhUSE – a global membership organization and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers and eClinical IT professionals – published a whitepaper titled Clinical Trial Transparency and Disclosure; A Global View. The whitepaper is part of their Clinical Trials Toolkit project, discussing mandatory requirements, voluntary activities, World Health Organization (WHO) registries, industry guidance, and the submission lifecycle.

Read the full transparency whitepaper.

How the UK proposes to regulate clinical trials in case of a ‘no-deal’ Brexit: Updated guidance released – Outsourcing-Pharma.com

The UK Government last week provided an update on the regulation of clinical trials in the event of a “no deal” Brexit, with a commitment to ensure any new requirements are not “unduly burdensome.”

Read Melissa Fassbender’s summary here.

Phishing: Why we should teach employees to be skeptics – Forbes.com

TrialAssure CIO Mohamad Zahreddine penned an article for Forbes.com this week discussing phishing attacks, explaining that “If a threat actor successfully phishes an employee, it can provide them access to the company’s entire network of resources throughout the enterprise.” The article goes on to give seven guidelines for how to speak with colleagues and change their behaviors.

Read the full piece on Forbes.com.