Clinical studies - Cardiac Safety Research Consortium

Volume 10 Issue 4

JOURNAL FOR

CLINICAL STUU DIES

Your Resource for Multisite Studies & Emerging Markets

PEER REVIEWED

Success with Adaptive Registries in

Rare Disease Research

Comparison and Compilation of RA and QA Requirements for Marketing Authorisation of Medical Devices

India, Singapore and Saudi Arabia

Methods to Reduce Placebo Response in

Antidepressant Treatment Trials

Writing Pediatric Study Plans

The Impact of the FDA 2016 Revised Guideline

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Contents

JOURNAL FOR

CLINICAL STUU DIES

Your Resource for Multisite Studies & Emerging Markets

MANAGING DIRECTOR Martin Wright

PUBLISHER Mark A. Barker

EDITORIAL MANAGER Virginia Toteva virginia@

DESIGNER Jana Sukenikova

RESEARCH & CIRCULATION MANAGER Orla Brennan orla@

ADMINISTRATOR Barbara Lasco

FRONT COVER istockphoto

PUBLISHED BY Pharma Publications Unit J413, The Biscuit Factory Tower Bridge Business Complex 100 Clements Road, London SE16 4DG Tel: +44 0207 237 2036 Fax: +0014802475316 Email: info@

Journal by Clinical Studies ? ISSN 1758-5678 is published bi-monthly by PHARMAPUBS

4 FOREWORD

WATCH PAGES

6 The Comprehensive In Vitro Proarrhythmia Assay: An Update

While the International Council on Harmonisation (ICH) S7B/E14 regulatory landscape has successfully prevented new drugs with an unrecognised propensity to induce the rare but potentially fatal ventricular arrhythmia Torsade de Pointes (Torsade) from entering the market, important and unanticipated limitations have become clear. Rick Turner, an Expert Consultant at DRT Strategies, Inc. and a member of the CSRC's Executive Committee, discusses that the CiPA approach represents a paradigm shift involving strategies that have the potential to improve early detection of genuine proarrhythmic risk.

8 Success with Adaptive Registries in Rare Disease Research

Clinical research in rare diseases has become intensely competitive, with stakes that are high both for sponsors and patients. Sean Kennedy at Syneos Health describes the adaptive registries which enable meaningful and efficient evidence generation for these specialised patient populations within a real-world context.

10 Working with the Regulators

Regulators such as the FDA and EMA are often perceived as roadblocks on the route to drug approval. Their role is not to make life for drug developers difficult, as they are stakeholders in the development process, responsible for ensuring the safety and efficacy of new medicines. Bruno Speder at SGS Clinical Research explains why early and frequent consultations with the regulators by pharma companies and their clinical research organisations (CROs) and contract manufacturing organisations (CMOs) will make the path to market smoother.

12 Developing Brown Fat Treatment for Tackling Obesity

Obesity has now reached epidemic levels worldwide. Consequently, there has been an alarming upsurge in major non-communicable diseases including type 2 diabetes, non-alcoholic fatty liver disease, coronary heart disease and cancer ? all of which negatively impact life expectancy. Karin Gillner at Symcel AB describes the activation and expansion of brown adipose tissue (BAT) as a method which has been shown to have beneficial metabolic impact.

14 Draft Guidance Addresses Inclusion of Adolescents in Oncology Trials

The opinions and views expressed by the authors in this magazine are not neccessarily those of the Editor or the Publisher. Please note that athough care is taken in preparaion of this publication, the Editor and the Publisher are not responsible for opinions, views and inccuracies in the articles. Great care is taken with regards to artwork supplied the Publisher cannot be held responsible for any less or damaged incurred. This publication is protected by copyright.

Volume 10 Issue 4 July 2018 PHARMA PUBLICATIONS

With an eye toward helping industry, investigators, and institutional review boards (IRBs), the US Food and Drug Administration (FDA) has unveiled draft guidance on the inclusion of adolescents in adult oncology trials. Elizabeth Hollis of Clarivate Analytics reveals in this article the importance of that as it is estimated that about 5000 US teens between the ages of 15 and 19 are diagnosed with cancer each year.

REGULATORY

16 The Impact of the New European Union Medical Devices Regulation (EU MDR) 2017/745 and MDR 2017/746

The European Economic Area (EEA) ? which includes the European Union (EU) and three of the four states of the European Free Trade Association (EFTA) ? has long been considered one of the largest global medical device markets. For device manufacturers, gaining and maintaining access to this important market is an obvious objective.



Journal for Clinical Studies 1

Contents

However, this also requires staying on top of regulatory changes to ensure timely product certification, says Sheena Dempsey at RWS.

20 Writing Paediatric Study Plans (PSPs) ? the Impact of the FDA 2016 Revised Guideline

Children make up approximately one-quarter of the world's population, but despite this the majority of drugs used in children are usually prescribed `off-label' and have not undergone rigorous testing within this population for safety and efficacy in well-controlled clinical trials. In this article, Diana Radovan and Rachel Beeby MSc at Trilogy Writing & Consulting discuss that drugs that work in adults may not necessarily work in children, and simply reducing the adult dose to account for children's reduced weight erroneously assumes proportional safety and efficacy.

MARKET REPORT

26 Advantages and Challenges of Outsourcing Post-marketing Study Activities

In the past, life science companies went through numerous clinical trial phases before gaining market approval and launching their products. Once those products were on the market, testing them was seldom a concern. However, in recent years, the necessity of proving that a drug works in the real world has become vital for a number of reasons. Todd Middleton at Cutting Edge Information discusses that among other goals, these studies assist in maintaining marketing authorisation, earning product reimbursement, collecting real-world evidence and improving market share.

30 Clinical Trials in Russia ? Report On 2017

Igor Stefanov at Synergy Research Group reveals that the Russian MoH approved 700 new clinical trials of all types including local and bioequivalence studies during 2017, demonstrating a 22% decrease in comparison with the same point of the last year.

THERAPEUTICS

42 FDA Actions to Improve Prescription Drug Labelling for Pregnancy

When healthcare providers look to prescribe a medication, ideally their decision is clear cut because ample clinical data exist in the relevant study populations. In reality, however, it is not uncommon that certain patient populations are not yet well captured. Deborah A. Komlos at Clarivate Analytics describes that this is the case for pregnant women, who usually are actively excluded from clinical trials. Actions by the US Food and Drug Administration (FDA) in recent years, including the issuance of new regulations and guidance documents, aim to remedy this shortcoming.

46 Methods to Reduce Placebo Response in Antidepressant Treatment Trials

Exaggerated and highly variable placebo response remains one of the biggest challenges in the development of drugs for major depressive disorder, resulting in numerous failed and negative trials. Henry J. Riordan and Roland Avrumson at Worldwide Clinical Trials reveals the recent FDA guidance, which suggests that substantial responses are typically seen in placebo groups in antidepressant trials.

TECHNOLOGY

50 Improving the Outcome of Translations in Clinical Studies

With the advent of increased globalisation of clinical trials, all stakeholders have adopted greater reliance on outsourced translations. Translations have become an essential link in the chain of development when successfully launching global products. Valerie Thorpe at Transcom explains that for any product that is propelled onto the global life-science stage, the pathway invariably includes conducting clinical study translations which must meet stringent local requirements in all of the countries where the clinical trial is conducted.

32 Transparency and Public Interest: Striking a Balance

54 Digital Revolution in Healthcare

As from next year, life sciences firms will be expected to prepare plainlanguage summaries (PLSs) for all Phase I?IV interventional trials, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014 (EU CTR Article 37). Pooja Phogat & Vidhi Vashisht of Kinapse explain why these requirements for plain-language summaries of clinical studies, aimed at a broad, non-technical audience, could create new risk for sponsors.

Like any other industry, the medical field is also becoming inevitably digitised. Digital transformation within the healthcare profession is something we can count on seeing in the future. We're already witnessing the confluence of emerging technology with healthcare and an increasing awareness of our own bodies, and this trend will only continue to develop and expand. In her article, Adhiti Sharad Kumar says that consumers seem readier to accept digital products than just a few years ago.

34 Using Open-source Software in Clinical Research

Clinical research more than ever relies on software tools during preparation, conduct and analysis of clinical trials. However, building and maintaining software for a highly regulated industry is expensive. In this article, J?rg Mielebacher at PCQ Pilots talks about the benefits of open-source software.

38 Comparison and Compilation of RA and QA Requirements for Marketing Authorisation of Medical Devices: India, Singapore and Saudi Arabia

56 Industry Joins Forces to Improve Collaboration Between Sponsors and CROs

As the complexity, size, length, and globalisation of clinical trials have steadily increased, so too have trial costs. A recent study estimated the average cost of bringing a drug to market at around $2.6 billion. Rik van Mol at Veeva Vault Europe discusses why sponsors are increasingly relying on contract research organisations (CROs).

58 Research Networks in the Digital Healthcare Environment: A Review

In order to market any medical device, marketing authorisation from a regulatory authority is required. The process of gaining authorisation is complex and multistep, and requires review of information by competent authorities. Dr Balamuralidhara V et al. from JSS School of Pharmacy, compare the marketing authorisation systems for medical device in emerging markets, i.e. India, Singapore and Saudi Arabia.

Teaching hospitals and academic institutions which band together to conduct research reap the benefits of the increasing digitalisation of healthcare. In this article, Luis Magalhaes, Randy Ramin-Wright and Le Vin Chin at Clinerion Ltd. examine the attendant benefits and challenges, with particular focus on electronic health records and the privacy issues relating to patient data.

2 Journal for Clinical Studies

Volume 10 Issue 4

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