GVP and Literature Monitoring in a Global World

The pharmaceutical industry is a rapidly evolving market that must meet demands worldwide. In recent years, pharmacovigilance has emerged as a critical element to sound clinical practice in the modern public health landscape. The overall aim to standardize Good Pharmacovigilance Practices (GVP) worldwide is to improve patient care and safety related to use of medicinal products.

Not all safety concerns and signals can be identified during clinical trials, thus measures to evaluate and screen post-market products must be implemented. It is currently recommended by the US Food and Drug Administration (FDA) that sponsors use internal spontaneous case reports as well as outsourced reports from external medical literature and clinical studies to monitor and possibly further evaluate signals of adverse drug effects 1.

New legislation for pharmacovigilance went into effect in the European Union (EU) in July 2012, including a series of modules and processes for GVP to ensure safe and consistent pharmacovigilance procedures in support of approved products.

The European Medicines Agency (EMA) Module VI – Management and reporting of adverse reactions to medicinal products is devoted solely to guide measures for GVP and focus on methods to enable safe routine pharmacovigilance procedures. According to Module VI, external literature searching of this nature would begin on submission to marketing authorities and continue thereafter 2. The weekly screening must encompass recognized scientific literature as well as international symposia and smaller local publications which may present unique and significant information 3.

The need for pharmacovigilance surveillance in external literature is apparent. However, current challenges and future considerations are constantly evolving. Globalization of clinical research and marketing has expanded drastically since 2003 4. The growth of internet publications, and the inconsistent nature of medical literature across various regions, all create valid concerns on how to adequately examine all writings.

1 United States. USDA. FDA. CDER. CBER. Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (March 2005). Web.

2 European Medicines Agency. Guidelines on good pharmacovigilance practices (GVP). EMA/501523/2015 (11 August 2015). Web.

3 European Medicines Agency. Heads of Medicines Agency (HMA). Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1). EMA/873138/2011 Rev 1. Web.

4 Drain, Paul K., Marion Robine, King K. Holmes, and Ingrid V. Bassett. "Trail Watch: Global Migration of Clinical Trials." Nature Reviews Drug Discovery 13.3 (2014). Web.

There are databases that exist with extensive medical literature, yet most of these writings are from well-known and accessible authoring companies. These databases do not encompass symposia, conferences, or smaller publications internationally mandated in the guidelines. Also, it is largely misunderstood that global literature, especially in smaller economic regions, follows a standard when it comes to the medical literature. Publication frequency is erratic, websites do not exist or are out of date, and often regional, professional, or membership restrictions are placed on acquiring literature, raising a challenge for pharmaceutical sponsors.

The key to detailed monitoring in order to satisfy regulatory concerns must encompass multiple aspects:

1. The geographic area as well as therapeutic focus of medical literature must be relevant to sponsor product and active ingredients.
2. The products and active ingredients must be properly translated into the local language and all linguistic variations per language need to be assessed and accounted for.
3. The search must also be constructed in a manner to capture all references to company product in advertisements or sub-text.

As the standards for GVP continue to expand, the penalties for non-compliance in global trials can be severe. The processes needed to continuously monitor the published literature creates strategic and quality benefits to outsourcing to a global partner. TransPerfect Life Sciences is structured as an ideal partner for such literature surveillance due to:

• Global Presence – TransPerfect is the world’s largest privately held language solutions provider, with offices in over 90 cities around the globe, thus having the global reach to provide direct local support on an international scale.
• Linguist Translations – The scope for monitoring literature encompasses clinical trials and marketed products in a multitude of regions around the world. TransPerfect has a network of over 5,000 certified linguists and subject-area specialists that can assess the relevance of the medical literature and provide quality translations of articles/journals, ICSRs, and safety cases within clinical trials, as well as other applications.
• Clinical Expertise – For more than 20 years, TransPerfect Life Sciences has supported the global development and marketing of drugs, treatments, and other products designed to improve and save lives. Our team is comprised of experienced individuals with diverse life sciences backgrounds to manage your literature monitoring and offer best practice recommendation.
• Technology – The medical journals and client deliverables to summarize discoveries can be stored in TransPerfect’s secure 21 CFR Part 11 compliant cloud-based platform, Trial Interactive. This creates a protected, streamlined process for linguists to upload and deliver documents, and for clients to access and download material. There are additional Trial Interactive features such as Q&A, reporting, and workflows that can be leveraged for client processes or needs. Other modules and use cases include safety databases, eTMFs, and investigator portals.

Pharmacovigilance standards to monitor post-marketing concerns will further develop as the industry evolves to protect and improve patient care. The services to provide superior quality and timely discoveries must evolve in parallel in order to be in compliance with regulatory obligations.