10. Roadmap of the Submission Process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

DOH’s “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices”

10.2 Pediatric Investigation Plan (PIP)

From the research conducted, no specific guidance is available in relation to PIPs. What is implied is that trials involving pediatric participants are subject to the same application process and approval procedure as clinical trials in the adult population. 

The DOH’s “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” contain the following provisions regarding clinical trials with minors:

“V. CLINICAL TRIALS WITH VULNERABLE GROUPS (VULNERABLE SUBJECTS) OF PATIENTS

21. Minors - Clinical trials on minors may be undertaken provided that:

• 21.1 The protocol has been approved by the IRB/REC after discussion of the clinical, moral, and psycho-social impact on childhood, in which at least two pediatricians have taken part;
• 21.2 A direct benefit is expected from the clinical trial for the group of patients that will be included in it;
• 21.3 The clinical trial is directly related to the clinical condition of the minors;
• 21.4 The medicinal product tested is intended to be used for diagnosis, treatment, or prevention of diseases that are specific to minors;
• 21.5 The purpose of the trial is to verify data obtained from clinical trials on individuals who are able to give informed consent or data obtained through other research methods, and the results obtained from clinical trials on adults and their interpretation may not also be considered valid for minors and young persons;
• 21.6 The trial is planned in a way to minimize pain, inconvenience, fear, and other foreseeable risks associated with the disease, and the level of risk and physical pain have been predefined and are constantly controlled during testing; 
• 21.7 No financial or other incentives are provided.” 

10.3 Clinical Study (Interventional or Observational)

DOH’s “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices”