drug safety report

By Ethical 11 May, 2021

Drug Safety Reporting and AE data reconciliation. The two systems and processes go hand in hand.

In the first place of the development of new medicines are clinical trials conducted for the establishment of what is commonly called the “benefit / risk ratio” of a drug and the basis of any such determination is drug safety reporting. The Adverse Event (AE) data reconciliation process comes to consolidate the drug safety data captured in both the clinical and safety databases as part of the overall drug safety reporting effort. For best efficiency, the two efforts are usually performed in parallel.

Protecting patient safety during clinical trials is one of the pillars of clinical development and the main focus of Good Clinical Practices (GCP), a set of global rules governing all clinical trials. Monitoring of a drug’s safety profile in order to protect participants from unwarranted risk, relies primarily on the collection, recording, classification, coding and reporting of Adverse Events (AE) during the conduct of clinical trials. In addition to the creation and maintenance of a safety database aimed at supporting the overall safety profile of the new drug, expedite reporting of certain types of events to health authorities is a mandatory step that ensures independent review and swift action should the suspicion arise of unwarranted risk to the participants in the trials. A robust drug safety reporting system is therefore paramount to the fulfilment of these obligations. 

Safety, efficacy and benefit-risk ratio.

All diseases create risk and burden to the health of people who suffer them. Medicines aim at reducing or canceling these but come with their own load of potentially unwanted effects. In the case of drugs the dose is very often the determining factor and special care is given during early stages of development to determining the optimal dose and regimen that maximizes the beneficial effects while minimizing any unwanted ones. 

All the beneficial effects are grouped under the term of “efficacy” and are measured using well established endpoints e.g. measurements that have been shown to accurately represent the status and evolution of the disease. The second pillar of clinical trials, called “safety” is assessed by recording and analyzing adverse events.  An adverse event (AE) is defined as “any unfavorable or unintended sign, symptom, or disease temporarily associated with the use of a medicinal product, whether or not the event is related to the product itself”.

A benefit-risk ratio is established taking into account the risks and burden due to the disease if it was not treated (or treated with another drug, in this case called a “comparator”) and the sum of adverse events collected in the drug safety reporting process. These two sides of the balance can be very different depending on the nature of the disease and the type of adverse events caused by the drugs used. One can imagine accepting more burden for the treatment for a life-threatening disease than that of a benign one. However, in all cases, the benefit-risk ratio guides the decisions of health authorities whether to allow a drug on the market or not. 

Serious Adverse Events and the drug safety reporting system.

Among all safety data collected in a drug safety reporting system, the most critical are those qualified as serious adverse events (SAE) which are those resulting in death, a threat to the patient’s life, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity, or a congenital anomaly or birth defect. The initial determination must be done by the principal investigator and appropriate action taken as soon as possible.

SAEs are managed differently from other AEs following a dedicated drug safety reporting process. Once the determination is made by the PI that an AE is serious, the sponsor of the study must be immediately alerted. In most drug safety reporting systems, safety information is captured in two parallel processes, one being integrated in the clinical data collection and cleaning (case report forms captured in the clinical database) and the other in an entirely independent process of safety monitoring and reporting to Health Authorities (safety database). 

Making sure that information captured in the drug safety reporting system is consistent in these two repositories is a multi-facet challenge impacting data quality, operations performance and compliance. The usual process of comparison and correction is called AE data reconciliation and involves several departments and competences. The process calls for a robust system for extracting and comparing AE information from the two databases of the drug safety reporting system. Such system must allow for easy, quick, precise and compliant reconciliation operations all along the study conduct and thus actively participates in the protection of patients’ safety.

Expedite Reporting and Alert

In the safety database, SAEs are coded, classified and described separately from the clinical database, and a subset of those events – the so-called SUSARs (Suspected Unexpected Serious Adverse Drug Reaction) must be reported to health authorities and involved Ethics Committees (EC)/ Investigational Review Boards (IRB) within a very short timeframe: seven calendar days if the event is death or life threatening and fourteen calendar days for all other types of events. This expedited drug safety reporting process ensures that health authorities maintain a holistic view of all ongoing investigations of a particular drug and can take swift action should the need arise.  

Beyond Clinical Trials

The accumulated knowledge of the benefit/risk ratio does not stop at the registration of the new drug but will link to a continuous monitoring drug safety reporting system called pharmacovigilance all along the life of the products on the market and sometimes even beyond.


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