This week, Clinical Trials Arena will shine a spotlight on the issues surrounding the new General Data Protection Regulation (GDPR), to be implemented in May 2018. Since the new regulation was announced, multiple organizations across various industries have tried to discern how exactly GDPR will impact business operations. For the life sciences industries in particular, there is a large amount of uncertainty concerning how GDPR will influence, say, how patient data is gathered and generated.

Throughout this week, CTA will provide the answers as key thought leaders share their two cents on GDPR, while advising how to prepare for its implementation. Experts, such as, Jackie Mulryne, Richard Dickinson, and Zoe Walkinshaw (Arnold & Porter Kaye Scholer LLP) explain the impact of GDPR on clinical trials. Meanwhile, Mustafa Ghafouri explains what GDPR will mean for patient confidentiality.

But first, be sure to visit CTA later today when Editor, Henry Kerali, sheds light on five key things to know about GDPR.

In the meantime, catch up on some CTA’s most recent stories delving into the challenges concerning clinical trial data… (click on the headline to finish reading).

Peace at Last? – Final Guidance on Lay Summaries of Clinical Study Results Released

After a long wait, it was at the beginning of August that the final guidance on lay summaries of clinical trial results was released as part of the EudraLex Volume 10 update (see references). Everybody in the new field of lay summaries had eagerly awaited the arrival of the final guidance as it was expected to remove a lot of insecurity on the interpretation of the EU clinical trial regulation.

The EU clinical trial regulation 536/2014 was the first regulation worldwide that mandates a “summary of study results that is understandable to laypersons” for all clinical trials conducted in the European Union. This was a big step towards transparency and greater patient friendliness. For the first time a document summarizing the results of a clinical study needs to be developed explicitly for a lay audience.

Disclosure of Clinical Trial Data by the EMA: Where are we now?

When, and in what circumstances, a third party can access clinical trial data submitted to the European Medicines Agency (EMA) once a product has been authorized continues to be a hot topic in the European Union (EU). The EMA has stated that one of its key goals is the publication of clinical trial data once the decision-making process is complete. This is because, it is said, it is important to establish trust and confidence in the regulatory system so the public has a better understanding of the regulatory decision-making process.

The EMA’s position has received the support of academic researchers and patient groups. There appears to be a perception that companies have, in the past, hidden “unhelpful” data and have not been pro-active in publishing negative results, so that many believe companies cannot be trusted to independently release data about their products…

Data Integrity Control Strategies – A Matter of Gaining Control

Data integrity is currently one of the hottest topics in GMP compliance and regulatory inspectors are committed to ensure pharmaceutical companies comply with regulatory requirements (as seen in Figure 1). Furthermore and most importantly, data integrity compliance is for the sake of the patients. Data integrity compliance and thereby trustworthy, accurate and complete data are necessary for assuring the safety, efficacy and quality of medicines and medical devices. In the pharmaceutical industry, a lot of emphasis has been put into control strategies within multiple areas: process validation, equipment qualification, production process control, and analytical strategies often applying a wide array of analytical methods. The concept is not widely applied for data integrity controls, but is a valuable tool that forces you to address focal points of data integrity compliance.

A Transformative Landscape: Clinical Analytics Systems as the Future Tool for Clinical Trial Management

Given our current technological landscape, it is difficult to imagine that approximately 20 years ago, electronic data capture (EDC) was just emerging as a novel tool for clinical trial management. Prior to this, paper collection of data at study sites, followed by duplicative manual data entry and analysis by the sponsor was the norm. Technological innovation of computer systems has made capturing and analyzing data for clinical trials easier, faster and more robust. This has resulted in improvements in data cleanliness and the speed at which the data can be analyzed while enhancing the assurance of patient safety. These advancements have also made it possible to collect even more data from more sources than ever before. Consequently, the implementation of a data analytics system on top of these many data sources used in a clinical trial can provide a transformative landscape for the future management of clinical trials and may facilitate reducing time to database lock, provided it is well designed and thought out.

 

PHOTO CREDIT: Descrier