What is the USFDA criteria Clinical trial models are based on

1. What is the USFDA criteria/ Clinical trial models are based on Before we go into clinical trials and its criteria, let us first understand what clinical trial is. The word trial brings many questions in mind. Trial means experiment? Is it safe? Do one should participate? Why is this allowed? Who controls this? It is well known in its definition that it is research study in which people participate where some patients suffering from some ailments and present available medicine does not help while new medicine under development is promising. This patient can volunteer for such trial as it may turn out beneficial for patient. As we all know such trials are governed by regulatory bodies. USFDA is considered such reputed regulator which is recognised in almost whole globe. USFDA itself never conducts any trial but as regulator it has set several criteria for conducting those trials. Let us look at those criteria to understand more about those trials. It is conducted through protocol, which is written and approved plan for executing, documenting, and reporting.

2. The protocol will decide type (age group, male or female, and number of patients (depending on the trial Phase) can enter, schedule and tests and drug under study, dosage to be used, how long and what is expected Volunteers who participate also must agree to certain rules of trial similarly the body which is conducting the trial are also governed by set of rules set by regulators like USFDA. These activities are very technical and many devices manufacturer or researcher may be expert in their study but may not be aware of regulatory requirements and guidelines. In such scenario, there are USFDA consulting firms are available who can support such projects. Drug development starts in research institutes and starts with scientific studies and once it meets basic criterial of known drawbacks like toxicity etc. it is put to animal trial called preclinical trial. Based on success of this actual human clinical trial starts. Like Phase 1 (20- 80 people) Phase II (100-300 People) Phase III (1000-3000). After successful Phase III trial regulators approves drug and the Phase IV trial starts where the researchers track the use of this on patients and its efficacy drawback. There are various models are designed for trials like placebo where some people selected randomly are given some safe excipients without drug. Neither the doctor nor patient knows about whether he/she is on placebo. This is one of the fastest ways to know the effect of new drug. Randomisation: In this case treatments are assigned to patients by chance and not by preferred selection. This is done to avoid Bias assigning volunteers. Blinded or masked, double blinded. This model is designed to prevent research team, or volunteers from influencing results. In case of blinded trial participant does not know what, they are given. In double blinded case even researcher and participants both do not know only pharmacists administering knows. Most important part of the clinical trial is clinical evaluation of entire study. This is one of the important steps of plan or protocol as evaluation only decides the success or failure and approval is based on that. So clinical evaluation is evaluation of trial data by experts which may include external experts, other research experts (peer review) apart from original experts. It is available for public library under study’s official name and protocol id number. There are some important steps which are defined as guideline like MDR and MDDEV. 1.Define scope of data evaluation and create a plan. 2.Identify data to be appraised and literature search study 3.Appraise data and summarise data sheets. 4.Perform analysis to see if they meet initial requirements. 5.Compile Clinical evaluation report. Thus, this entire exercise is for the benefit of patients involved, researcher to find out better way to treat, diagnose, and understand human disease.

3. IZiel adopts an analytical mindset thus enabling us to root out all possible non- conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals.