Clinical Study Protocols: The Pillars of Clinical Develpment

Welcome to the 2023 Medical Writing Supplement developed as a collaboration between Samedant Ltd and Trilogy Writing & Consulting and published as part of the Winter edition of International Clinical Trials (ICT).  In this edition, we focus on the importance of well-written clinical study protocols as pillars in the pharmaceutical industry’s search for efficiencies and reduced drug development time. Our aim is to raise awareness of the far-reaching impact that well-crafted protocols can have on study quality and drug development speed.

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Medical Writing – A Bold New Path: The Future Awaits Us

The second edition of Trilogy’s special edition magazine, Medical Writing – A Bold New Path: The Future Awaits Us, was published at the beginning of 2020.

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Medical Writing: The Backbone of Clinical Development

In the end of 2016, experts from the world of medical writing were brought together to support an industry-wider initiative – a special edition magazine on Medical Writing.

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The Future of Medical Writing: A Panel of One

Of all the points in the evolution of the medical writing profession, I believe we are at the pinnacle of what promises to be the most exciting and biggest paradigm shift in medical writers’ roles and responsibilities. With an accompanying leap in the introduction and use of technology in ways we have only dreamt of until now, this is a huge opportunity for all of us. However, it will also require medical writers to expand and hone their already extensive skill sets, and for their managers to embrace new technology and empower their teams to really grow and flourish into their new roles. For those forward-thinking companies, the rewards— including increased job satisfaction, faster and more effective submissions and approvals, increased general public engagement, and productivity from their teams—promise to be significant.

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Artificial intelligence for medical writing, part two: transparency, flexibility and control

In an earlier article about artificial intelligence (AI) for medical writing1, I stressed that AI tools would assist, accelerate and augment the process of clinical documentation. I also argued that the key to the third aspect, augmentation, was the use and future acceptance of standard texts. This, of course, is going to be the hardest to implement and where most of the pushback occurs. Everyone is in favour of making the preparation of clinical documents easier and faster, but when you start talking about standardising the text, the acceptance drops precipitously. In addition, many writers feel uncomfortable with a tool that seems to be taking their thinking away from them and produces a document that they don’t understand or feel connected to. So how do we address these challenges to bring the huge potential power of AI to the writing of clinical documents? I believe that the keys are transparency, flexibility, and control.

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AI for Medical Writing: Assistance, Acceleration and Augmentation

The promise of AI for the field of medical writing has been apparent for some time and a number of teams have created tools of varying effectiveness and scope.

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Assistance, Acceleration and Augmentation

AI is set to play a significant role in regulatory and medical writing in the very near future. Dr Barry Drees of Trilogy Writing & Consulting, using his more than 30 years of experience, discusses the history of medical writing, the challenges facing his company in implementing AI industry-wide, and why computer-augmented reports are necessary.

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Truth be Told: Where AI and Automation Can Really Take Us

AI and automation are both exciting and daunting prospects in the future of medical writing, but the advantages of these tools should be scrutinised, as well as what they mean for medical writing professionals.

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How to streamline a complex process: why experienced medical writers will add value to oncology dossiers

Oncology is one of the most common areas of drug development in the pharmaceutical industry. In 2020, many of the new drugs approved by the FDA were cancer treatments.

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Lean Medical Writing: Story not Storage

The most difficult task an author can face is clearly summarising a complex and data-filled clinical regulatory document and explaining the data. Barry Drees, co-founder and senior partner of Trilogy Writing & Consulting, discusses the recent concept of ‘lean medical writing’ (LMW), and how it is being implemented and used in the pharmaceutical industry.

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The Future Awaits Us

Off the back of the release of Trilogy Writing & Consulting’s second special edition magazine, EPC sits down with Barry Drees to expand on medical writing trends in the industry.

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Help Reviewers Tell You What They Want

Reviewers of regulatory documents need to ensure that their comments are specific, actionable, and relevant, so that no critical time is spent unnecessarily throughout the document development process.

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Achieving a Work-Life Balance as Medical Writers

In any industry, there is considerable evidence of the value and improved productivity for those who maintain a healthy work-life balance, and we should not forget that a near total neglect of life is not sustainable.

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Quality-Driven Medical Writing

For years, the clinical drug development industry has been waging war against the surging drug development costs and tediously long processes.

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How to Build a Medical Writer: Medical Writing Apprenticeships – New Training for a New Breed

Everyone involved in preparing regulatory documentation in the pharmaceutical industry is always on a desperate look out for excellent medical writers with years of experience writing the documents they need.

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Help Reviewers Tell You What They Want

Review is an integral part of the medical writing process and relies on clear communication between the medical writer and the reviewer(s).

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Getting the most out of quality control specialists: Practical guidance for medical writers

Quality control (QC) is a process that usually occurs when a document is in a near-final or final state. It involves the checking of documents by QC specialists against source data (e.g., comparing data in tables and checking that analytical statements are supported by the data presented in the document) and/or for consistency (e.g., spelling, grammar, punctuation, formatting, style, and crossreferences).

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Back to the future… or the amazing lack of progress in effective document review

In 1999, as a still relatively inexperienced medical writer, I was introduced to some software that was going to revolutionise document preparation: Documentum, a collaborative reviewing tool for regulatory documents.

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The history of The Write Stuff: 10 years of bringing European medical writers together

Barry Drees reflects on 10 years as editor of the journal of European Medical Writers Association.

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The Clinical Evaluation Report: Document Writing and Compilation

Trilogy offers high-end medical writing that goes beyond just making sure a document is structured properly: it involves content-driven sanity checks, a sense of ownership of the documents  and offering strategic support on all areas of document production – from advising on best options for data presentation and helping teams focus on messages, to suggestions on best practice for review scenarios, coordinating team timelines and proactively managing cross-functional input.

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The Clinical Evaluation Report: Bringing it Together

In light of recent regulations, it is important to discuss the general aspects and strategies for writing and compiling a CER.

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Strategic medical writing for device submissions

Julia Forjanic Klapproth of Trilogy Writing & Consulting GmbH elucidates how it’s time to start using strategic medical writing in the world of device submissions.

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Getting the Writing Right

Gerry McGregor, a principal medical writer at Trilogy Writing & Consulting, explains how experienced medical writers can help medical device manufacturers to meet the new regulatory demands of producing clinical evaluation reports.

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You Get What You Give

Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, explains how to prepare good requests for information and proposals in the field of medical writing.

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Do You Measure Up?

For any service, the end user wants a way to measure the performance of the service provider to understand if they are getting good value for money.

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Successfully outsourcing medical writing

A large proportion of medical writing activities are now outsourced. This means the need for medical writing service providers is growing, and with increased demand there comes an increased supply of providers.

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Under the Hammer

Inappropriate use of reverse auctions puts suppliers at an unfair loss and disadvantages buyers.

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Reverse auctions: the perfect folly for sourcing clinical research services

Are reverse auctions (e-auctions) between suppliers of services as good as sometimes claimed?

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Cutting Back: solutions to reduce the time and costs of clinical development

Outsourcing and Functional Service Provision (FSP) of medical writing

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Medical Writing: Outsourcing Guide

What and when to outsource, how to find a medical writing partner.

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Plain Language Summaries of Publications – what has COVID-19 taught us?

Plain Language Summaries of Publications – What Has COVID-19 Taught Us? The COVID-19 pandemic has significantly impacted the whole world and the public has had to struggle with understanding scientific data on a daily basis. The impact of scientific misunderstanding became painfully apparent with the decline in vaccine uptake and so the need for clear, understandable scientific information has never been more vital. Plain Language Summaries of Publications (PLSPs) could be an elegant and much-needed solution to this problem. This article will explore what these documents are, the approaches taken to date, and the challenges that still remain. The authors will aim to answer the question – what has COVID-19 taught us?

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Communicating with Patients. Who and How?

Despite the fact that patient-friendly versions of many regulatory documents are now mandated by the regulations, the most frequently encountered reaction to communicating patient information is apathy. In this article, Dr. Lisa Chamberlain James explains why communicating with patients is key and how the new regulations will reshape the conversation about patient-friendly versions of regulatory documents. Read More

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Do We Need to Involve Patients in Clinical Study Report Lay Summaries?

Translating complex clinical regulatory documents into versions that are understandable to patients and the general public was never going to be an easy task, but it is a very necessary, important, and now legally mandated one.

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Writing for Patients: When and How

In a drive for more patient-centric healthcare practices, medical writers are increasingly required to present medical and health information in an easy-to-understand, ‘plain language’ format. The move towards patient engagement and patient involvement in healthcare decisions (‘shared care’) has triggered a raft of new guidances from regulatory authorities, accompanied by new regulations mandating that pharmaceutical companies engage with patients and the general public in a way that has been improbable up to now. While this has generally been supported and welcomed by both industry and patients, the initiative has brought with it considerable challenges.

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Lay Summaries and Writing for Patients

Lisa Chamberlain James of Trilogy Writing & Consulting and Trishna Bharadia, patient engagement consultant, examine the trend for increasing and more transparent patient information, and ask how close we have come in the past few years to producing useful and meaningful information for patients.

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The Lay Summary – Remember the Reader

Founded in 2002, Trilogy Writing & Consulting specialises in high-end medical writing. Senior partners Lisa Chamberlain James and Barry Drees examine the 10 suggested headings in the EMA regulation CTR EU No 536/2014, and outline potential issues and oversights that could potentially lead to misinterpretation.

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Lay Summaries and Writing for Patients: Where Are We Now and Where Are We Going?

We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients.

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The Lay Summary – Remember the Reader

As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (patients and others not in the pharmaceutical industry).

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Mind the Gap

Why the move for more and better patient information is gathering momentum.

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Communicating with Patients – Common Sense or a “Black Art”?

Good patient information maximises the benefits and intended use of a medicine.

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The challenges of producing periodic benefit–risk evaluation reports

This article discusses the challenges of producing a periodic benefit–risk evaluation report (PBRER) from a writing perspective. It explains that by taking into consideration the most common pitfalls encountered by regulatory assessors, companies can improve the quality of their PBRERs and reduce regulatory requests in the future.

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Regulatory submissions of non-interventional post-authorisation safety studies: Challenges for data interpretation and comparisons with clinical data

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns.

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The Pharmacovigilance Medical Writer: Medical Writer, Project Manager, Regulatory Expert

Pharmacovigilance is a critical element of drug development and marketing. The evaluation and monitoring of patient safety and a drug’s benefit/risk is a highly regulated global task, which is required continuously throughout a drug’s lifecycle.

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Using social media as the patient’s voice in the benefit-risk assessment of drugs: Are we ready?

There is no doubt that the public interest in healthcare-related issues is growing. This, coupled with the surge in the use of social media, leaves the pharmaceutical industry with a set of unique opportunities and challenges.

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Strategic Medical Writing in the Post-Authorisation Phase

The latest legislation for the most common post-authorisation documents (RMP, PSUR, safety studies).

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Using Questionnaires in Clinical Research – A Guide through the Data Jungle

Emphasis is growing on quality of life, treatment costs, real-life effectiveness and patient outcomes.

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Planting the Seed: Post-Marketing Research

The importance of good planning and communication for the success of postmarketing research.

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How to Streamline Regulatory Authority Meetings

Streamlining meetings with regulatory authorities is a continually evolving process. But what role do briefing documents play, and what is the best way to produce these effectively? The development of investigational new pharmaceutical products is a long and winding road, and regulatory authorities play a role throughout the process. If sponsors wish to obtain approval for a marketing application from a particular region, they need advice and guidance from the regions’ regulatory health authorities. This request for advice and guidance usually results in one or more meetings. Since these meetings aim to provide guidance and information for the sponsor to help direct and mould the product’s development, they occur at critical stages of the regulatory process on the way to a submission for approval.

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The FDA, EMA, and PMDA Questions: How to Respond During Review of CTD Submission Dossiers

While the ICH’s Common Technical Document (CTD) is an internationally agreed format for preparing application dossiers needed for obtaining approval to market a drug, the ensuing review process is specific to the country or region in question. Irrespective of the differences in process between countries and regions, questions will almost always be issued during the review process, with a request for written responses.

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Taming the Complexity of Preparing CTD Submission Dossiers

Process optimisation and effective management and organisation strategies are essential components when preparing CTD submission dossiers for drug approval. “Be prepared.” In his book, Scouting for Boys, Robert Baden-Powell introduced this motto in 1908 as the basis for successful boy scouting.

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Implications of Policy 0070 for the Writing of Clinical Dossiers

EMA Policy 0070 requires the publishing of all clinical reports submitted as part of MAAs, so it is important to highlight what new challenges this may bring for the writing of these documents.

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Implications of policy 0070

Julia Forjanic Klapproth, of Trilogy Writing & Consulting, and Jo Anne-Marie Blyskal, from Teva Pharmaceuticals, take a detailed look at the implications that policy 0070 transparency requirements will have on clinical dossiers – and what this means for those preparing them.

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The Challenge of CTD Submissions and Responding to Questions from the Authorities

The Common Technical Document is an international standard for the summary documents needed to obtain regulatory approval of medicinal products. These summary documents involve presenting key information drawn from a large body of data, with input from a range of stakeholders within a project team.

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Battling with clinical submissions: War rooms and other tricks of the trade

Submission dossiers – the most interesting and challenging documents for a medical writer.

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Finding the Answers

Responding to authority questions – how medical writers can streamline the relay race.

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Reaping the Benefits from Improved Clinical Study Protocols

Clinical study protocols are important cornerstones on the journey of collecting the clinical data needed to elucidate the benefit-risk profile of medical treatments/devices. Not only do they lay down the plan for the study at hand, they serve as a repository of knowledge for the strategic intentions and will be used for multiple down-stream activities. They are the basis for trial registration, provide guidance to those running the study, and will be used by participants, ethics committees/institutional review boards, funders, regulators, journal editors, and systematic reviewers to appraise the study.

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Streamlining Clinical Study Protocols and Reports

Recent pharma initiatives have been established to help ensure that clinical study protocols and reports are always presented in a similar way, making for easier assimilation and assessment.

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Words of Wisdom: writing Protocols

The ABCs of writing effective Clinical Study Protocols

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The Clinical Development Plan – The Importance of Getting it Right

The challenge of mixing marketing, pre-clinical, production, pharmacovigilance, and regulatory groups throughout the CDP process should not detract from its simplicity when clinical experts work together in tandem.

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What you Need and When – The Key Documents in the Drug Lifecycle

Clinical development is a complex and expensive undertaking, involving many years of research that culminate with clinical trials, the objectives and results of which all have to be documented.

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A New Standard for Medical Writing

Discrepancies in the ways in which the documentation for clinical drug development is structured and presented have hampered understanding and progress for decades.

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Medical Writing in the Old World

Although there has been what amounts to medical writing here for a long time, it is a relatively new concept as a specialized profession.

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The Investigator’s Brochure – A multidisciplinary document

The Investigator’s Brochure (IB) B is primarily written to enable investigators to assess risks and benefits.

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Regulatory Questions and Answers: The Investigator’s Brochure

Advice on the appropriate format for the Investigator’s Brochure.

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Writing Pediatric Study Plans (PSPs) – The Impact of the Revised 2016 FDA Draft Guidance

An initial Pediatric Study Plan (iPSP) is an outline of the paediatric study or studies that the drug development sponsor plans to conduct in the US to confirm the suitability of drug usage in the paediatric population.

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Medicines for Children

Preparing the Paediatric Investigation Plan (PIP) application.

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Risk Management Plans – New challenges for a new era

The complexity of the new RMP, not least the summary for the lay reader, is challenging writers.

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Improving Transparency and Benefit/Risk Assessments with the New Risk Management Plan

Personalised health care – “shared decision-making” with patients relies on them being well informed.

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Biosimilar Development – An Overview

Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use.

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