Common Terminology Criteria for Adverse Events (CTCAE)

The NCI’s Common Terminology Criteria for Adverse Events (CTCAE; http://ctep.cancer.gov/reporting/ctc.html) is a longstanding empirically developed “dictionary” or lexicon, designed for use in clinical trials to aid clinicians in detecting and documenting an array of adverse events (AEs) commonly encountered in oncology.

An AE is a term that is a unique representation of a specific event used for medical documentation and scientific analyses. Each AE is graded on a scale of 1 (mild) to 5 (death related to AE).

There is growing awareness that collecting symptom data directly from patients using patient-reported outcome (PRO) tools can improve the accuracy and efficiency of symptomatic AE data collection.

The NCI’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) system provides a web-based platform to collect patient reports of symptoms they are experiencing while undergoing treatment for the purpose of enhancing adverse event (AE) reporting http://outcomes.cancer.gov/tools/pro-ctcae.html). To date, 81 symptoms of the CTCAE (version 4) have been identified to be amenable to patient reporting. These symptoms have been converted to patient terms (e.g., CTCAE term “myalgia” converted to “aching muscles”).


Source: http://outcomes.cancer.gov/tools/pro-ctcae_fact_sheet.pdf

How to Monitor new medicines and vaccines- MHRA

New chemicals and vaccines are effectively put on probation for up to two years and labelled with a black triangle to ensure prescribers are aware of the need to monitor them carefully. The black triangle symbol accompanies new medicines and vaccines in prescribing manuals, product information, and advertising material. It prompts healthcare professionals to report any potential side effects to the MHRA. This information helps to build up a broader picture of how the treatment works in the general population and enables the MHRA to act promptly, should a previously unrecognised and serious side effect come to light. The black triangle may also be assigned to a medicine that has already been licensed if it contains a new combination of active chemicals or if it is being used in a new way or for a different condition. The black triangle is not removed until the MHRA is satisfied that the medicine works safely in large numbers of people. Additionally, the MHRA also asks manufacturers to keep a close watch on side effects that may be associated with newly marketed products.

Source: MHRA Guidelines

Dictionary - Clinical Research

http://www.michr.umich.edu/tools/dictionary/G-I.htm

Understand the SAE process

When an SAE report is sent by an investigator, health worker, or employee (clinical research associate or pharm center), it is immediately assigned a number and reviewed to determine whether the event is a reportable SAE. If it is reportable, the company needs to send the SAE to FDA by one of the following methods.
• Form 3500A only (can be filed manually or electronically via the AERS system)
•A narrative report
• VAERS form (vaccines only)
• CIOMS I form (foreign reports only).

A company’s culture and experience dictate the way it meets these reporting requirements. Whatever the method it uses, a company must keep an audit trail, either manual or electronic, that shows
• the initial receipt date of the SAE
• all changes made to the original SAE by any personnel.
• all supporting documentation requested and sent in from the site.
• any internal or external correspondence.
• any internal notes, such as medical review.
• all attempts to get additional information regarding the event.
• whether the event is open or closed.

We need to code the SAEs in such a way that they become categorical in nature, such as assigning a code for the event and a MedDRA term

Source: FDA Guidelines

Pharmacovigilance software

The EMEA or the European Medicines Agency in Europe develops and maintains the pharmacovigilance database of probable serious adverse effect medicines in the market. This system is called EudraVigilance.

 

Similarly, the US medical society has its own pharmacovigilance branches namely; the FDA; the academic and non-profit organizations like RADAR and Public Citizen and the pharmaceutical manufacturers. Several companies like Aris Global, Relsys and Workflow have developed pharmacovigilance software to keep track of safety applications in the market.

 Kinds of pharmacovigilance software:

 

PV Works for example is a pharmacovigilance software system that records report safety data keeping track of adverse event reporting. It is a commercial workflow engine providing management control of pharmacovigilance processes. Flexible data entry, risk management, safety system assessment, evaluation and submission of regulatory reports are some of its important features.

 

PV Works (Vet) is another software system made to support veterinary pharmacovigilance business and technical processes meeting the necessary safety standards. Data entry, reporting, audit trail are some of its main features.

The outsourced pharmacovigilance software develops drug development expertise, safety rules and regulatory necessities, securing client access to data and regular tracking and status updates to clients or to the authority. It is an economical project development process making using of the electronic medium for handling management purposes.

 

The Assured pharmacovigilance software provides Internet access to the server for the client’s use and operation of the system for management and customer use. This software meets the standards of pharmaceutical companies, regulatory authorities and medical personnel.

 

How effective is pharmacovigilance software?

• Pharmacovigilance software minimizes the risk of adverse events (ADR) by using genetic profiles.
• It makes accurate determinations as to whether a product is safe or not.
• It determines the benefit-risk ratio quickly
• It overcomes the challenges that small firms face as far as limited financial and personnel resources are concerned.
• Pharmacovigilance software helps maintain regulatory compliance and improve operational efficiency.
• Global information can be easily shared by means of this software.
• In the age of safety concerns, more need is being felt for software that can avert probable risks and also help in worldwide networking in the medical field. Pharmacovigilance software is designed just for this.

Source: FDA and EMEA Guidelines