Patient narrative is a summary of AEs occurring in a clinical trial patient/subject. It is generally written for the following criteria: Death, serious AE (SAE), event(s) of special interest, AE leading to study drug/trial discontinuation, and adjudication event(s). It should be written in a structured way with clear, concise, and logical flow of information. It should follow succinct style and presentation and should provide a medical and scientific context in terms of the event(s) for which it is being written. The logical flow to describe event(s) in a patient narrative is as described below:
Cioms V Narrative Template
Download Zip: https://fulcdaevka.blogspot.com/?file=2vFxXh
Where death is reported as an outcome of a SAR, this should be considered a fatal event and expedited within the reporting timelines as SUSARs, as fatal events are to be considered unexpected unless explicitly stated in the RSI and approved by the competent authority. We have seen SARs in database listings with a fatal outcome incorrectly assessed as expected, with the organisation indicating this was due to disease progression (due to other information available in the narrative of the SAE report). However, in these instances there should be appropriate training of investigators on pharmacovigilance requirements for the trial, including SAE reporting and causality assessments. If a death is due to disease progression this means that a serious adverse event occurred, the event was disease progression and the outcome is fatal. Therefore, this is not a SAR and cannot be a SUSAR. If the investigator believes that disease progression was caused by the IMP, then disease progression is a SAR, the outcome is fatal and a SUSAR report is required (unless fatal disease progression is a SAR included in the RSI). If conflicting information is provided by the investigator the Sponsor should follow up via a query to ensure accurate reporting.
Assess the impact of CTFG Q&A on RSI on your quality system and on your clinical trial safety data to determine if there has been any under-reporting of SUSARs. If you have identified any, these should be reported as a serious breach. It is recommended that you map out the process from end to end and include all stakeholders and departments impacted. If your organisation uses an IB template, it is recommended that this is also reviewed to ensure the RSI section is in accordance with the CTFG Q&A on RSI.
Methods: Comprehensive narrative review explored the pharmacovigilance activities related to vaccines in opposition to other pharmaceuticals, with emphasis on acceptance of adverse events, rechallenge, dechallenge, causality assessment, and benefit/risk assessment.
Methods: We identified the suspected drugs reported by both consumers and healthcare professionals reported from the West Midlands area (population 6 million) in the UK from April 2013 to March 2020. Reports were categorised as either consumer or healthcare professional (HCP) and suspect drugs were categorised into their BNF chapter (5). The odds ratio and confidence interval was calculated for each BNF chapter. The number of characters in the narrative describing each reaction was also calculated.
Adverse event narratives, sometimes called patient narratives or safety narratives, are a summary of each adverse event of every clinical trial participant in a study on an investigational product. They become a critical component of a clinical study report, submitted to regulatory agencies, during the conduct of a clinical trial. Typically, medical writers are responsible for writing them from a collection of tables, listings and figures provided to them from different teams managing the clinical database or reporting on the clinical database.
To better understand the content in a narrative, it may help to visualize some of the clinical trial data associated with a subject. The patient profile (shown below) may be used to show adverse events along with other relevant clinical data. It contains much of the same information as in a narrative but in graphical form. I will use subject 101014 as an example throughout this blog post for consistency so that you may recognize the differences in presentation of our semi-automated adverse event narratives. There are quite a few adverse events experienced by the subject, three of which are serious denoted with an asterisk, and two of these are concurrent and classified as fatal.
After gathering the requirements from the guidance documents and input from medical writers on the content of paragraph text, we are ready to start the process of generating the narratives. In order to automate the generation of adverse event narratives, we need access to the clinical database, which is typically the primary data source.
One very important usage of these CDISC data standards, primarily SDTM and ADaM, can be adverse event narratives, but the requirements for narratives often are not being designed into these models. Therefore, SDTM or ADaM data must be evaluated and potentially augmented to create effective adverse event narratives. If it is not possible to get the teams that manage the SDTM (as well as supplemental qualifers) and/or ADaM data to create the necessary variables, then a third party must take ownership of this process. Since the SDTM and ADaM variability within an organization can still be high, it is necessary to make decisions about how much work should be done to harmonize the requirements of the medical writers versus delivering narrative features immediately for the sake of time. JMP Clinical is a very helpful tool to help you evaluate your data for readiness with semi-automated narrative generation and deliver out-of-the-box features immediately until there is time to modify the data and code to create the perfect adverse event narrative. In the end, it may not be necessary to reach perfection as we are able to merge any supplemental data from any of the databases with use of an optional supplemental data table input field for the adverse event narratives.
In a much earlier version of JMP Clinical, version 4, we introduced the ability to create adverse event narratives with options to select whether the user just wanted to print serious adverse events or all all adverse events as well as deciding whether to just print treatment emergent events or pre-treatment, post-treatment, etc. These options, available from dialogs (as shown below) in the software, provided flexibility for the end user to decide which content they preferred in their safety narratives. Now with JMP Clinical 7.1, these options have increased due to customer requests.
Upon seeing these more organized "by subject" narratives, customers asked for a clear and concise summary of each participant using tables formatted to indicate 1) demographic information, 2) adverse events sorted by severity of event type and then study day, and finally another table for medical history with concomittant medications and additional information for oncology therapies.
Notice that participant number 101014, shown in the examples above, falls into multiple adverse event categories and will appear in the fatality section of the document since they had at least one fatal adverse event. Customers have requested that we start organizing the adverse event narrative document by the categories of fatal, serious but not fatal, non-serious leading to discontinuation and special interest. These features get us one step closer towards semi-automating the entire adverse event narrative section of the clinical study report. In order to accomplish this, we need to summarize all participants with an event in a way that the reader can quickly assess them and the categories into which they fall. See the example below:
The latest version, JMP Clinical 7.1, which was released in August 2019, contains even more new features of adverse event narratives with built-in table views of data than shown above. Customized tables of any laboratory data or other data is now possible with a single line of code. Using our new automation API to load studies into the system and run reports, you may not have to click a single button to generate adverse event narratives again. However if you are having to triage questions from regulatory authorities and generate adverse event narratives for subjects that had not been included in the clinical study report, it is possible to use any visualization in our system to quickly generate these with the click of a button.
Wang Shirley V, Pinheiro Simone, Hua Wei, Arlett Peter, Uyama Yoshiaki, Berlin Jesse A et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies BMJ 2021; 372 :m4856
Arthur Kleinman, a psychiatrist and anthropologist, argues that rich narrative descriptions of patient history and experience can help to address the fundamental and existential issues of meaning of the illness medically and personally.
Based on the book The Hot Zone by Richard Preston, the film is a plague narrative that depicts an outbreak in Africa of a highly infectious airborne virus. The movie brought to a wide audience the public health ethical issues that might arise from an Ebola-like virus.
Elliott uses a Wittgensteinian approach to discuss issues about the moral challenges confronting modern medicine. Topics include illness and identity, psychopharmacology, the role of clinical ethicists, and narrative in medicine.
Aggregate reporting involves preparation and submission of safety reports for a given medicinal product to worldwide regulatory agencies and constitutes an essential part of safety monitoring of a medicinal product. There are specific aggregate safety reports required for a molecule in development called development safety update reports while Periodic Adverse Drug Experience Reports (PADERs) and Periodic Safety Update Reports/Periodic Benefit-risk Evaluation Reports (PBRERs) are submitted for products with marketing authorization. Based on the periodic analysis of worldwide safety reports, product label is updated to optimize safe use of a medicinal product. PADERs are aggregate safety reports to be submitted to the Food and Drug Administration (FDA) for products approved for marketing in the United States (US). PADER submission starts once marketing authorization approval is received for a medicinal product by the sponsor. Quarterly and annual PADERs should be submitted within 30 and 60 days of data lock point, respectively. PADERs mainly involve presentation of case reports with serious unlisted events (15-day alert reports) in the form of narratives or in a tabular format. The present article focuses on the background, scope, structure of a PADER, and its submission timelines; lists differences between PADER and PBRER; and describes the knowledge, skills, and attitudes required for a PADER writer. 2ff7e9595c
Comments