Clinical Write Up: Clinical Trial Protocol Writing
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Clinical Study Report Tips
Let us now give you an understanding of making a Clinical Study Report (CSR). CSR on a clinical trial is a very long and detailed document giving much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. Results of trials are usually reported in a briefer academic journal paper, but methodological flaws are often glossed over in the briefer paper. The content of a CSR is similar to that of a peer reviewed manuscript. The CSR includes summary sections, appendices, and many details, but the meat of the document is comprised of sections already familiar to you: introduction and background, experimental methods, description of study subjects, efficacy results, safety results, and conclusions. The CSR should expedite the reviewer’s job. Even though all study data are in the tables and appendices at the end of the CSR, liberal use of in-text tables and figures allows the reader to find important study results without having to bounce back and forth between the text and appendices.
The clinical study report described here is an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (referred to herein as drug or treatment) conducted in patients, in which the clinical and statistical description, presentations, and analyses are integrated into a single report, incorporating tables and figures into the main text of the report, or at the end of the text, and with appendices containing the protocol, sample case report forms, investigator related information, information related to the test drugs/investigational products including active control/comparators, technical statistical documentation, related publications, patient data listings, and technical statistical details such as derivations, computations, analyses, and computer output etc. The integrated full report of a study should not be derived by simply joining a separate clinical and statistical report. Although this guideline is mainly aimed at efficacy and safety trials, the basic principles and structure described can be applied to other kinds of trials, such as clinical pharmacology studies. Depending on the nature and importance of such studies, a less detailed report might be appropriate. This guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized and easy to review. The report should provide a clear explanation of how the critical design features of the study were chosen and enough information on the plan, methods and conduct of the study so that there is no ambiguity in how the study was carried out. The report with its appendices should also provide enough individual patient data, including the demographic and baseline data, and details of analytical methods, to allow replication of the critical analyses when authorities wish to do so. It is also particularly important that all analyses, tables, and figures carry, in text or as part of the table, clear identification of the set of patients from which they were generated.
Depending on the regulatory authority's review policy, abbreviated reports using summarized data or with some sections deleted, may be acceptable for uncontrolled studies or other studies not designed to establish efficacy (but a controlled safety study should be reported in full), for seriously flawed or aborted studies, or for controlled studies that examine conditions clearly unrelated to those for which a claim is made. However, a full description of safety aspects should be included in these cases. If an abbreviated report is submitted, there should be enough detail of design and results to allow the regulatory authority to determine whether a full report is needed. If there is any question regarding whether the reports are needed, it may be useful to consult the regulatory authority. In presenting the detailed description of how the study was carried out, it may be possible simply to restate the description in the initial protocol. Often, however, it is possible to present the methodology of the study more concisely in a separate document. In each section describing the design and conduct of the study, it is particularly important to clarify features of the study that are not well-described in the protocol and identify ways in which the study as conducted differed from the protocol, and to discuss the statistical methods and analyses used to account for these deviations from the planned protocol.
The full integrated report of the individual study should include the most detailed discussion of individual adverse events or laboratory abnormalities, but these should usually be reexamined as part of an overall safety analysis of all available data in any application. The report should describe demographic and other potentially predictive characteristics of the study population and, where the study is large enough to permit this, present data for demographic (e.g., age, sex, race, weight) and other (e.g., renal or hepatic function) subgroups so that possible differences in efficacy or safety can be identified. Usually, however, subgroup responses should be examined in the larger database used in the overall analysis. The data listings requested as part of the report (usually in an appendix) are those needed to support critical analyses. Data listings that are part of the report should be readily usable by the reviewer. Thus, although it may be desirable to include many variables in a single listing to limit size, this should not be at the expense of clarity. An excess of data should not be allowed to lead to overuse of symbols instead of words or easily understood abbreviations or to too small displays etc. In this case, it is preferable to produce several listings. Data should be presented in the report at different levels of detail: overall summary figures and tables for important demographic, efficacy and safety variables may be placed in the text to illustrate important points; other summary figures, tables and listings for demographic, efficacy and safety variables should be provided; individual patient data for specified groups of patients should be provided as listings in Appendix; and all individual patient data (archival listings requested only in the US) should be provided in Appendix. In any table, figure or data listing, estimated or derived values, if used, should be identified in a conspicuous fashion. Detailed explanations should be provided as to how such values were estimated or derived and what underlying assumptions were made. The guidance provided below is detailed and is intended to notify the applicant of virtually all of the information that should routinely be provided so that post submission requests for further data clarification and analyses can be reduced as much as possible. Nonetheless, specific requirements for data presentation and/ or analysis may depend on specific situations, may evolve over time, may vary from drug class to drug class, may differ among regions and cannot be described in general terms; it is therefore important to refer to specific clinical guidelines and to discuss data presentation and analyses with the reviewing authority, whenever possible. Detailed written guidance on statistical approaches is available from some authorities.
Each report should consider all of the topics described (unless clearly not relevant) although the specific sequence and grouping of topics may be changed if alternatives are more logical for a particular study. Some data in the appendices are specific requirements of individual regulatory authorities and should be submitted as appropriate. The numbering should then be adapted accordingly. In the case of very large trials, some of the provisions of this guideline may be impractical or inappropriate. When planning and when reporting such trials, contact with regulatory authorities to discuss an appropriate report format is encouraged. The provisions of this guideline should be used in conjunction with other guidelines.
TITLE PAGE: The title page should contain the following information: − study title − name of test drug/ investigational product − indication studied − if not apparent from the title, a brief (1 to 2 sentences) description giving design (parallel, cross-over, blinding, randomized) comparison (placebo, active, dose/response), duration, dose, and patient population − name of the sponsor − protocol identification (code or number) − development phase of study − study initiation date (first patient enrolled, or any other verifiable definition) − date of early study termination, if any − study completion date (last patient completed) − name and affiliation of principal or coordinating investigator(s) or sponsor’s responsible medical officer − name of company/sponsor signatory (the person responsible for the study report within the company/sponsor. The name, telephone number and fax number of the company/sponsor contact persons for questions arising during review of the study report should be indicated on this page or in the letter of application.) − statement indicating whether the study was performed in compliance with Good Clinical Practices (GCP), including the archiving of essential documents − date of the report (identify any earlier reports from the same study by title and date).
2. SYNOPSIS: A brief synopsis (usually limited to 3 pages) that summarizes the study should be provided (see Annex I of the guideline for an example of a synopsis format used in Europe). The synopsis should include numerical data to illustrate results, not just text or p-values. 3 Structure and Content of Clinical Study Reports.
3. TABLE OF CONTENTS FOR THE INDIVIDUAL CLINICAL STUDY REPORT: The table of contents should include: − the page number or other locating information of each section, including summary tables, figures and graphs; − a list and the locations of appendices, tabulations and any case report forms provided.
4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS: A list of the abbreviations, and lists and definitions of specialized or unusual terms or measurements units used in the report should be provided. Abbreviated terms should be spelled out and the abbreviation indicated in parentheses at first appearance in the text.
Do note that the above given tips are provided only as a general guideline and would vary based on the requirement of the project. However even with these instructive steps it is not possible for researchers to do a good clinical study report and so on like how our expert research writers do. This is here where you need the help of our research company. After you have completed your clinical trial, we can also save you time by assisting with writing your manuscript. We can help complete a manuscript you have already begun or work with you from the beginning to develop a manuscript from your CSR or raw data. We have writers and editors with expertise in hundreds of areas of medicine and can add a little extra time to your day by assisting with your manuscript writing and editing at any stage. Our writers can: Start with your raw data and outline or clinical study report (CSR) to draft a submission-ready manuscript; Work from your partially written case report or manuscript to prepare and polish a completed draft for submission to your selected journal; Ensure that your manuscript is clearly written and adheres to your selected journal’s author guidelines. If you hate the tedious final stages of manuscript writing, we can help. Our editors will generate a final draft that clearly expresses your ideas in concise, grammatically correct language. We will even format your manuscript to meet the requirements of your selected journal at no extra charge. After your paper has been reviewed by the journal, we can help you polish your manuscript revisions and your response letter to the journal editor and reviewers. So why wait? Read below for more details.
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