Golden Rules for Clinical Document Development: Making the Most of Your Medical Writer

Life science i technical bulletin ISSUE N°32 /DECEMBER 2009

AUTHOR: Inge Leysen, Medical Writing Coordinator, SGS Life Science Services

Introduction

Medical writing is a broad field, as testified by the many different names applied to the profession: medical writing, scientific writing, and regulatory writing to name but a few. The field covers the development of a whole spectrum of document types from medical communication documents such as posters, slide sets and journal manuscripts to regulatory documents such as clinical study reports (CSRs) and Investigator’s Brochures (IBs). Some writers have experience with the whole spectrum; others mainly develop expertise with a subset of document types. But the ultimate challenge in any case is to tailor style and level of detail to suit the intended audience.

Medical writing not only covers various qualitative medical writing. A majority of attain the level of knowledge of a product document types, it also encompasses the specific expertise will be contributed that in-house writers in a pharmaceutical diverse therapeutic areas, diseases, by other clinical research professionals; company accumulate. They are, however, drugs and several specialized fields such each specialized in their own field. In the trained through frequent practice to as early phase clinical research, imaging, same light, the ability to acquaint oneself adjust their writing to new topics and new medical devices, or orphan drugs. In-depth rapidly and effectively with a new topic requirements. In addition, they gather a knowledge of a therapeutic area, disease is a fundamental quality for a medical broad experience of dealing with different or even a drug is undoubtedly an asset writer. Freelance and CRO-based writers obstacles or different approaches to similar but not a prerequisite for efficient and typically don’t have the opportunity to hurdles.

More Than a Writer

A medical writer should cultivate a Ability to synthesize, analyze Ability to deal with substantial time successful blend of linguistic and scientific and summarize large amounts of pressure skills. In addition, since a significant complex data Knowledge of ICH guidelines amount of a writer’s time is invested in A critical mind that does not lose (e.g., ICH E3, E14, …), regulatory sorting through large amounts of complex itself in inconsequential details requirements, and at least the data and discussing them with other basics of statistics clinical research professionals, a critical and Ability to convey a clear, meaningful communicative mind is also invaluable. message with a limited amount of From Start to Finish of a Clinical Trial text The answer to the question “when is Indispensable skills and qualities in a a medical writer involved in a clinical Ability to communicate with and medical writer are: trial?” will often be: “at the very end, reconcile comments of various when the data are analyzed and ready clinical research professionals; Life science i technical bulletin 2

to be summarized in a CSR”. But since Review the CRF Write the CSR the development of a CSR involves close The quality of the data collected A medical writer will take the collaboration of the writer with clinical trial during a clinical trial hinges on the protocol, SAP and statistical analysis, managers, data managers, biostatisticians, quality of the CRF. A small oversight and in some cases also the CRF, and regulatory affairs representatives and or an ambiguous phrase can mean rearrange carefully selected parts of clinical or scientific experts, it pays to a valid question left unanswered at them into an integrated description involve the writer earlier in the process. the end of the trial. From their first- of the conduct and outcome of the A medical writer is uniquely suited in hand experience with the ultimate clinical trial. The resulting draft will function and experience to monitor the destination of the gathered data, then be revised in close collaboration interrelation of documents with each medical writers can make valuable with the clinical research team in other and promote consistency of format contributions to a CRF. charge of the study. The ultimate and even content across a range of goal is a multipurpose document documents. Review the SAP that satisfies the demands of Medical writers can sometimes science, clarity and applicable What can a medical writer do? have a more nuanced picture than guidelines such as ICH E3. statisticians do of what readers Write or edit the clinical trial protocol of study reports will find clear and Prepare a poster, slide presentation or While the design of the trial is in straightforward. Therefore, a writer journal manuscript the hands of the clinical research can make useful suggestions at the These documents require a team and protocols are often time of SAP development. different writing style than the written by global project managers, above-mentioned documents as a medical writer can deliver added Participate in the review of blinded data their purpose is not only to present value towards document structure, listings before database lock results accurately and concisely but clarity and consistency. Apart from Data managers generally look also to capture and hold the interest directing trial conduct, the protocol at data in a context of individual of the intended audience. will be the basis for a range of other subjects while writers look from documents such as the Case Report a perspective of study groups and Across Clinical Trials Form (CRF), Informed Consent Form objectives. The combination of both (ICF), Statistical Analysis Plan (SAP), approaches before database lock The writing of documents that summarize and ultimately the CSR. Therefore a can prevent having to elaborate on information across clinical trials (such as well-written, clear, unambiguous and (apparent) discrepancies in the CSR. IBs and integrated summaries) requires consistent protocol can save a lot of the writer to take a step back from the people a lot of time and effort. Review draft statistical tables data and rearrange it into a more concise, After the statistician, the medical logical, manageable and navigable whole. Write the ICF writer will be the one spending It is essentially the same process as The writing of informed consent most time with the statistical CSR writing, but on a larger and more forms demands a simple, straight- analysis. Quite apart from detecting comprehensive scale. forward style. Here more than in any errors at an early stage, a writer’s other document, the writer needs to suggestions for organization and Besides being the actual document author, ensure not only that the information presentation of data can save both the writer often also acts as a coordinator is correct, but also that it will be writers and other users of statistical of the efforts of an interdisciplinary team understood correctly. output valuable time. throughout the document’s life cycle. Life science i technical bulletin 3

Useful Investments of Time

During document development major and Template: a good template should that meet rigorous scientific quality minor questions regarding content and incorporate preferred formatting standards and are compliant with ICH, format inevitably arise. Many of these and structure. It can even supply regulatory and company requirements. questions will recur numerous times paragraphs of preferred wording With their dedicated team of flexible, or perhaps worse, may not be asked provided the whole remains flexible. motivated and highly qualified writers who explicitly, leading to wrong assumptions have a broad experience with the whole Style guide: a style guide promotes and wasted effort. This can be prevented spectrum of medical communications consistency and can prevent a lot by investing a little extra effort at the and regulatory documents as well as of repetitive discussion thereby outset to build mutual understanding and an array of therapeutic areas, SGS can yielding a manifold return on the agreement among all parties involved. provide a wide scope of rigorous medical invested time. writing services, which can be limited to Pre-writing meeting: whatever the the writing a single document or framed type of document, it is imperative Medical writers are clinical research in the larger context of full clinical trial for efficient writing to know experts who need to be familiar with all management. beforehand what the expectations steps in the conduct of a clinical trial. In are, where the focus should be, close collaboration with an interdisciplinary which data are most relevant, etc. team, medical writers deliver documents

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