Adverse events in clinical trials could be classified as serious in which case they are called Serous Adverse Events (SAEs). These events are critical for all clinical trials because they directly contribute to drug safety profile and could rule out if the drug is acceptable or not. If there are lots of SAEs associated with specific drug then the regulatory agencies may not approve it on the market or approve it for limited patient population, which will not be affected by the safety concerns.
What are the main criteria to establish if an adverse event is serous?
1. Death – for some clinical trials death may not be considered as SAE.
3. Hospitalization – for some clinical trials with hospitalized patients, hospitalization may not be considered as SAE.
4. Disability or permanent damage
5. Congenital abnormality or birth defects – majority of the clinical trials require patients to use proper contraception when taking clinical trial drug.
6. Required Intervention to Prevent Permanent Impairment or Damage
7. Other Serious (Important Medical Events) – this is based on physician discretion and this is why it is important that physicians assess all adverse events for patients on clinical trials.
Serious Adverse Events normally require to be reported to the sponsor within 24 hours after the team was made aware of the event.
When clinical trials teams report SAEs they have to provide all relevant medical information related to the event. This may sound as simple and straightforward task but in reality it is more complicated.
What are the common problems obtaining SAE medical information?
- Patient was admitted in a different hospital or in a hospital abroad while on vacation.
- Patient is not in a condition to provide information on what assessments were done – the patient could be unconscious or in distress.
- Patient was treated in several different hospitals.
What could be done to collect all relevant information?
- Notify all relevant parties when patient starts clinical trial – it will be advantage if the GP and local hospital which patient attend, are aware that the patient is participating in clinical trial. It is also important that they are aware of the requirements for serous adverse events reporting and that this safety information is critical not only for the patient but for all patients taking this medication.
- Explain to relatives or care assistants the importance to report serous adverse events – Family members and care assistants could be vital source of information. Make sure they understand how important is to report SAEs.
One of the biggest challenges is if the patient is admitted in a hospital abroad. There is no easy way to obtain information form hospital, which is outside of the country network, but attempt could be made to contact the Ethics Committee or relevant ethics organization within the hospital. They could support communication and making the best decision for patient treatment.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 15 June 2014