The Investigational New Drug Process


This post is part of 'Domain | General' series

Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.

In the IND application, developers must include:

  • Animal study data and toxicity (side effects that cause great harm) data

  • Manufacturing information

  • Clinical protocols (study plans) for studies to be conducted

  • Data from any prior human research

  • Information about the investigator

The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:

  • Approval to begin clinical trials.

  • Clinical hold to delay or stop the investigation. 

A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.

The developer is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports.

This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.

source: fda.gov





Filter a category
AllSASnRSDTMSASDomainADaMStatistics

List of other posts


Domain


General
What are CDISC standards?
What is a clinical development plan?
What is a clinical study report?
What is a clinical trial registry?
What is the importance of baseline characteristics in a clinical trial?
Drug discovery
Drug Development
Preclinical Research
The Investigational New Drug Process
What is ICH?
Efficacy data vs Safety data
What is a clinical trial?
Why are clinical trials conducted?
What is a clinical trial protocol?
Who conducts clinical trials?
Inclusion/Exclusion Criteria in a clinical trial
What are the phases of clinical trials?
What happens after a clinical trial is completed?
FDA Drug Review
Key steps in developing new drugs and biologicals

Trial design aspects
What is a crossover clinical trial?

Terminology
What is a cohort?

SAS


Definitions
What is a computer?
What happens when we execute a SAS program?
What is software?
What is SAS?
What is data?
What is data entry?
What is data retrieval?
What is data management?
What is "Report"?
What is statistics?
What is Statistical Analysis?
How do we use SAS?
What kind of questions can SAS help us answer?
How do we provide instructions to SAS?
What is a SAS program?
What does a SAS program contain?

General
Attributes of a SAS dataset
Rules for SAS dataset names
Rules for SAS variable names
Rules for SAS library names
Rules for character SAS format names
Reserved SAS dataset names
Rules for numeric SAS format names
What can SAS dataset options do?
Attributes of a SAS variable
Automatic conversion of data types in SAS
How does SAS expect our data to be organized?
Introduction to SAS interface
By groups in SAS

Informats
Rules for character SAS informat names

Proc freq
Count the number of times a particular value occurred in a variable of a dataset

Proc contents
Check the list of variables in a SAS dataset

Proc datasets
Delete all sas datasets from a library
Delete specific sas datasets from a library
Save specific sas datasets (and delete others) of a library
Rename SAS datasets using proc datasets change statement

Log issues
WARNING: No matching members in directory.

One-line definitions
What is a SAS library?
What is a libref?
What is an input statement?
What is infile statement?
What is set statement?
What is length statement?

SDTM


General
How to derive baseline flag in SDTM
How to create SEQ variable in SDTM
New domains in SDTM IG 3.3
What is a codelist?
How to derive study day variable in SDTM
What is SDTM?
Why do we need SDTM?
How to convert original results to standard results using conversion factors

Demographics
What information does SDTM.DM (Demographics) contain?

Adverse Events
What is causality assessment?
What information does SDTM.AE (Adverse Events) contain?

Disposition
What information does SDTM.DS (Disposition) contain?

Concomitant Medications
What information does SDTM.CM (Concomitant/Prior Medications) contain?

Procedures
What information does SDTM.PR (Procedures) contain?

ADaM


General
What is ADaM?

ADSL
What is ADSL as per ADaM standard?

BDS
What is BDS as per ADaM standard?

Statistics


General
Alpha and beta errors
What is correlation?

SASnR


Introduction
What is R?
What is an R package?
What is tidyverse?
What are the core packages of tidyverse?
What is haven package of tidyverse?
How to install tidyverse?
How to load core tidyverse packages into the R session?

Reading data
Import/Read SAS dataset into R

Creating sample data
How to create some sample data in SAS and R tidyverse

Subset variables (columns)
How to select only required variables/columns in SAS and R tidyverse?
How to drop unwanted variables/columns in SAS and R tidyverse?

Subset observations (rows)
How to select/subset required rows in SAS and R tidyverse

Appending data
Append two datasets in SAS and R tidyverse

Merging/joining data
Merge/full join two datasets in SAS and R tidyverse
Merge/inner join two datasets in SAS and R tidyverse
Merge/left join two datasets in SAS and R tidyverse

Sort (order) observations
Sort/order observations based on the values in a single variable in SAS and R tidyverse

Transpose/Restructure data
Restructure/transpose long data to wide data
Restructure/transpose wide data to long data

Obtain frequencies
Obtain frequencies/counts based on one variable - one-way frequencies in SAS and R tidyverse
Obtain frequencies/counts based on two variables - two-way frequencies in SAS and R tidyverse

Descriptive statistics
Descriptive statistics for a numeric variable using SAS and R tidyverse