Every year thousands of people across the world take part in clinical studies. These studies may involve patients, healthy people, or both. Health care professionals carry out these carefully designed studies to help answer questions about new treatments, such as:
- if treatments are effective
- if treatments have any side effects
- if new treatments are better than the standard available treatments
Each clinical study must follow specific guidelines called a protocol. Each protocol is reviewed and approved by independent institutional review boards and ethics committees before any patients can be enrolled in the study. This is to protect the rights and safety of the study participants. Additionally, each clinical study is submitted to the competent regulatory authority in each study site’s country for approval.
Clinical studies are conducted following an international standard called ICH-Good Clinical Practice and are regulated by national law (ICH stands for “International Conference on Harmonisation”).
For a registry of clinical studies, go to Clinicaltrials.gov or the EU Clinical trial register can be accessed via this link. If you are interested in learning more about clinical research you can visit https://www.eupati.eu/.
Once the study protocol is approved by above mentioned boards and authorities, the hospital or medical research center will start to identify patients to participate in the study. The informed consent process is in place to ensure that all patients are fully briefed about the study and understand the nature of their participation in both oral and written form. The informed consent document in written form contains, for example, information about:
- the study, including its purpose, duration and study drug
- study procedures
- potential benefits and potential risks
Patients will be given time to read the informed consent document, to discuss their participation with family or close relatives, and take time to make their decision.
If the decision is made to join the clinical study, the patient will be asked to sign the informed consent document. In studies like the PETITE study, where patients are newborn babies, the document will be signed by the baby’s parents or guardian.
Once you have signed the consent, you may choose to stop study participation at any time for any reason without the decision affecting your baby’s care.
How Can You Help Advance Research?
You can help advance research by participating in a clinical research study. This is a crucial way to test and further develop new treatment options for newborns and to improve the lives of babies with neonatal seizures. Participation in a clinical research study like the PETITE study can impact the ability for new treatments to become approved for use in babies.
There are a number of benefits to participating in a clinical study: Your baby will be assessed by highly qualified medical practitioners or doctors and receive high quality standard of care; in addition, your baby will be monitored by continuous video EEG for the entire Evaluation Period. Your baby’s participation will be beneficial to the community as it will allow scientists and pharmaceutical companies to increase their knowledge of diseases and develop new medications.