MMS Blog

  • Clinical Trial Disclosure: More “FDA” Needed in Past & Present Acts?

    Posted on 11/29/2012 9:54 AM

    Federal mandates calling for transparency of clinical trial information have been in place in the United States since 1997, but a recent move will finally give the current FDA (Food and Drug Administration) law some teeth to enforce compliance. In September, the US Department of Health & Human Services (HHS) transferred authority from HHS control to the FDA to oversee information that is filed to ClinicalTrials.gov (“clinical trial registry data bank”), and seek out those who fail to file, o

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  • How to Build a Document Review Team: A Medical Writing Guide

    Posted on 10/11/2012 10:45 AM

    Whether it’s the completion of a clinical study report (CSR) for a clinical trial, or the completion of a submission document for a drug development program, medical writing represents the culmination of many people’s work over the course of many years. Due to the number of stakeholders involved across multiple functional areas, medical writing tends to be a consensus‑driven process, representing many contributor’s thoughts and ideas. Building the right review team can significantly contribute t

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  • Clinical Disclosure Reporting: Are You Prepared to Meet the Expanding Requirements?

    Posted on 9/7/2012 10:54 AM

    A group of House Democrats led by Congressman Edward Markey (D-Mass.) on Aug. 2 introduced the Trial and Experimental Studies Transparency (TEST) Act of 2012 (H.R. 6272), legislation that "updates and expands the clinical trial registry data bank—ClinicalTrials.gov—with stronger reporting requirements," according to a press release dated that same day (1). This proposed legislation is yet another step to address the increasing demand for greater transparency of clinical trial information. As we

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  • What NOT to Do When Writing a Clinical Study Report

    Posted on 8/17/2012 11:52 AM

    Clinical study reports (CSRs) describe the methods and results for each individual clinical trial. CSRs are included in the clinical part of the submission, so it’s important they are well written and easy to understand. As almost every clinical trial protocol is unique, the CSRs that describe their results will also need to be uniquely crafted. There are ICH guidelines (ICH E3) about what to do in the CSR but here are a couple of informal tips about what NOT to do when writing a CSR: Ignore th

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  • Setting Ground Rules for Medical Writing Document Review

    Posted on 8/8/2012 12:01 PM

    A medical writer often has to be a jack of all trades in order to ensure accurate, on-time completion of clinical documents. Document review provides a critical opportunity for the medical writer to elicit value-added review from team members. The medical writer can lead strategically by clarifying team members’ roles and responsibilities, setting clear expectations for reviewers, and setting “ground rules” for document reviewers at the outset of the project. The below are suggestions for medica

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  • Herbal Medicine in Clinical Trials: Regulation and Challenges

    Posted on 8/2/2012 12:05 PM

    According to the World Health Organization (WHO), traditional medicine refers to health practices, approaches, knowledge, and beliefs incorporating plant, animal, and mineral based medicines, spiritual therapies, manual techniques, and exercises, applied singularly or in combination to treat, diagnose, and prevent illnesses or to maintain well-being. If the material being used is of plant origin, then it is called traditional herbal medicines. In the Chinese pharmacopoeia (2005 edition), nearly

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  • Drug Patent Evergreening: An Overview

    Posted on 7/26/2012 12:24 PM

    First let’s see what patent ever-greening is and how it came into existence? Patent ever-greening refers to a strategy of obtaining multiple patents that covers various aspects of the same product. Even though it is not a formal concept of patent law, patent owners utilize this process to extend their monopoly privileges. Some examples include seeking subsequent patents on derivatives of existing drugs, altering the mixture of isomers, identifying compounds with the same molecular formula but

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  • Part 1: DIA 2012 Annual Meeting, Recap and Highlights

    Posted on 7/19/2012 12:28 PM

    The 2012 Drug Information Association (DIA) Annual Meeting in Philadelphia is in the books, and I am very grateful to have had the opportunity to speak at a lecture session in the Medical Writing and Medical Communications track. The 90-minute session, titled, “Medical Writing Competencies and Best Practices in the Global Environment”, focused on specific, applied ways that medical writers can employ strategies for efficient drafting, review, and management of documents. From developing and ef

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