Optimizing Pagination for Readability: The Importance of Consistency and Accuracy in Pharmaceutical Reports
Adverse events are an important aspect of drug development and post-market surveillance. They refer to any untoward medical occurrence that may happen to a patient who is receiving treatment with a drug, whether or not the event is related to the drug. Adverse event tables are commonly used to document these events in clinical trials, and they are an important tool for identifying safety signals and assessing the risk-benefit profile of a drug.
SOC system
The use of a hierarchical system for adverse event reporting allows for a standardized and consistent approach to documenting and summarizing adverse events. It also enables easy comparison of adverse events across different studies and drugs. The SOC system can follow the MedDRA (Medical Dictionary for Regulatory Activities) classification system, which is widely used in the pharmaceutical industry and regulatory agencies.
The SOC system includes 27 different categories, including “Blood and lymphatic system disorders,” “Cardiac disorders,” “Gastrointestinal disorders,” “Hepatobiliary disorders,” “Immune system disorders,” “Infections and infestations,” “Metabolism and nutrition disorders,” “Musculoskeletal and connective tissue disorders,” “Neoplasms benign, malignant and unspecified (including cysts and polyps),” “Nervous system disorders,” “Pregnancy, puerperium and perinatal conditions,” “Psychiatric disorders,” “Renal and urinary disorders,” “Reproductive system and breast disorders,” “Respiratory, thoracic and mediastinal disorders,” “Skin and subcutaneous tissue disorders,” “Surgical and medical procedures,” “Vascular disorders,” and “Social circumstances.”
Each SOC category includes several high-level group terms, which are further divided into high-level terms and preferred terms. For example, under the “Blood and lymphatic system disorders” SOC, the high-level group term “Leukopenia and/or neutropenia” is further divided into high-level terms such as “Leukopenia,” “Neutropenia,” and “Agranulocytosis,” which are then further divided into preferred terms such as “Lymphopenia,” “Basophilia,” and “Eosinophilia.”
The use of a hierarchical system also allows for flexibility in the level of detail reported. For example, a study may choose to report adverse events only at the SOC level, providing a broad overview of the types of adverse events observed. Alternatively, a study may choose to report adverse events at the preferred term level, providing a more detailed view of the specific adverse events observed.
In clinical trial reports
Clinical trial reports, regulatory submissions, and other documents require clear and concise presentation of information to enable effective review and decision-making. However, large and complex datasets, such as adverse event tables, often present challenges in terms of page layout and pagination.
The old way
The goal can be to minimize content splitting across pages to improve comprehension and readability of reports. Keeping groups of information together aids in the review of results, and before the re-pagination algorithm was implemented, programmers had to manually insert page breaks into the input reporting data set using the PGBREAK variable. This process was time-consuming and prone to errors, especially when dealing with large datasets.
The solution
To address this issue, an algorithm can be developed to automate the process of page layout and pagination. The algorithm performs a “best fit” calculation to determine where to put the page breaks in a manner that minimizes splits across pages. This approach not only improves table production but also ensures consistency and accuracy in page layout.
Furthermore, there are times when SAS, both with ODS RTF and ODS TAGSETS.RTF, produces output that is mistakenly spread across two pages. In such cases, the new pagination algorithm can help fix this issue by ensuring that the appropriate content is assigned to each page.
Why is it important
The importance of accurate and consistent page layout and pagination cannot be overstated. In the pharmaceutical industry, these elements play a critical role in the effective communication of clinical trial results and adverse event data to regulatory agencies and other stakeholders. Failure to adhere to standards in this area can result in delays in approval or rejection of a drug, which can have significant financial and reputational consequences for pharmaceutical companies.
To ensure that pagination is accurate and consistent, it is important to establish clear guidelines and standards for page layout and pagination. These guidelines should include clear instructions on the use of page breaks, footnotes, and other elements that affect page layout. Additionally, the use of automated tools, such as the re-pagination algorithm described in this article, can help ensure consistency and accuracy in page layout across large and complex datasets.
In conclusion, minimizing content splitting across pages is essential for improving comprehension and readability of reports in the pharmaceutical industry. The development of a re-pagination algorithm that performs a “best fit” calculation to determine where to put the page breaks can help automate the process of page layout and pagination, ensuring consistency and accuracy in the presentation of clinical trial results and adverse event data. It is important to establish clear guidelines and standards for page layout and pagination and to use automated tools to ensure consistency and accuracy in these elements.
