Adverse events are one of the critical aspects in clinical trials. Proper collection of potential adverse events will allow adequate safety information on the future drug label and also allow the regulatory agency to assess drug safety in comparison to current standard of care medications. Majority of the clinical trials require all adverse events reported by the patient to be documented and reported to the sponsor. Often clinical trials teams are struggling to collect all that information due to varies reasons – patient forgot to mention it or did not realize it is important, adverse event was reported to GP or another physician, etc.
In order to collect all adverse events information it is important that patients understand how critical is this for their own safety and medication profile. It is also important that all health care providers, which the patient is visiting, are aware that the patient is participating in clinical trial.
What can be done to improve safety reporting process?
1. Educate your patients – Explain to your patients during the consent process the importance of reporting adverse events. Encourage the patient to contact the clinical trial team if there are concerns that the patient may forget to report the adverse event during the next visit.
2. Inform GP and other health care professionals who are looking after the patient – Make sure they know that the patient is part of a clinical trial and they are aware of possible side effects. You can easily do this by providing them with list of common adverse events, especially for product that is not on the market yet and there is limited information.
3. Ask someone from study team to follow up with the patient – Some clinical trials have a big treatment window and patients may not come to the hospital frequently. By the time they come to the hospital for their visit, they may forget the adverse events that have had. You can ask a nurse or someone from the study team to contact the patient and check if there are any adverse events.
4. Inform the relatives – It is beneficial to inform patient family about the importance of reporting adverse events. Sometimes relatives could be better source of information.
Preparing a list of common adverse events could be very beneficial for the study team and will allow them to keep track on possible complications. Also this will help physicians to properly evaluate the causality of the adverse event.
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 13 May 2014