Industry Reports

The Thomson CenterWatch 2007 Survey of Investigative Sites in the U.S. finds that: sites have rated Kendle, Covance, Omnicare as Top CROs to work with.

Basics & Books to Read

Basics:

Clinical Trials Terminology for SAS Programmers

http://www.lexjansen.com/pharmasug/2004/tutorials/tu03.pdf

Pharmaceutical Programming: From CRFs to Tables, Listings and Graphs, a process overview with real world examples

http://www.lexjansen.com/pharmasug/2005/posters/po12.pdf

SAS ® PROGRAM EFFICIENCY FOR BEGINNERS

http://www.ats.ucla.edu/STAT/sas/library/nesug00/bt3005.pdf

SAS Books:

SAS Certification Prep Guide: Base Programming

SAS Programming in the Pharmaceutical Industry

The Little SAS Book

More:

Visit: "SaS9 Learn to Lead"

http://sas9.blogspot.com/

Preparing for SAS Base Certification?

1. The best way to prepare for certification is: To read the book: SAS Certification Prep Guide: Base Programming for SAS 9 . This book helps in understanding the basics of SAS Programming.
2. After mastering the book, one can try solving questions in this blog: http://sascert.blogspot.com/ (which is very useful). There are about 120 questions and it is worth reading.
3. For all who wd plan to take the exam: "Only practical programming make someone a better programmer".

SAS Certified Base Programmer Credential for SAS 9

2 hours duration
70 multiple-choice questions
Must answer 46 correctly to pass

SAS Programming I: Essentials

Course Contents

Getting Started with SAS

• overview of the SAS System
• introduction to SAS programs
• running SAS programs
• mastering fundamental concepts
• diagnosing and correcting syntax errors
• exploring the SAS environment (self-study)

Getting Familiar with SAS Data Sets

• explaining the concept of a SAS data library

Producing List Reports

• getting started with the PRINT procedure
• sequencing and grouping observations
• identifying observations (self-study)
• using special WHERE statement operators (self-study)

Enhancing Output

• customizing report appearance
• formatting data values
• creating HTML reports

Creating SAS Data Sets

• reading raw data files using column input and formatted input
• examining data errors
• assigning variable attributes
• changing variable attributes (self-study)
• reading Microsoft Excel spreadsheets (self-study)

Programming with the DATA Step

• reading SAS data sets and creating variables
• executing statements conditionally
• dropping and keeping variables (self-study)
• reading date fields from Microsoft Excel spreadsheets (self-study)

Combining SAS Data Sets

• concatenating SAS data sets
• merging SAS data sets
• combining SAS data sets using additional features (self-study)

Producing Summary Reports

• introduction to summary reports
• generating basic summary reports
• using the REPORT procedure
• creating reports using the TABULATE procedure (self-study)

Introduction to Graphics using SAS/GRAPH Software (Self-Study)

• producing bar and pie charts
• enhancing output
• producing plots

Additional Resources:-

Using SAS Enterprise Guide

• creating the files needed for the course
• understanding functional areas in SAS Enterprise Guide
• naming a project
• working with existing code
• resizing windows in SAS Enterprise Guide
• modifying code
• executing SAS code
• viewing SAS Enterprise Guide output
• diagnosing and correcting syntax errors
• reating SAS programs
• accessing data sources with the LIBNAME statement
• renaming a code node in the Process Flow window
• submitting programs
• saving projects
• the Output Delivery System (ODS) and SAS Enterprise Guide
• copying SAS programs within a project

Introduction to Graphics Using SAS Enterprise Guide

• producing and modifying a vertical bar chart
• producing and modifying a pie chart
• producing a horizontal bar chart
• producing a two-dimensional plot

SAS Programming II: Manipulating Data with the DATA Step

Course Contents

Introduction

• review of SAS basics
• review of DATA step processing
• review of displaying SAS data sets
• working with existing SAS data sets

Controlling Input and Output

• outputting multiple observations
• writing to multiple SAS data sets
• selecting variables and observations
• writing to external files

Summarizing Data

• creating an accumulating total variable
• accumulating totals for a group of data

Reading and Writing Different Types of Data

• reading delimited raw data files
• controlling when a record loads
• reading hierarchical raw data files

Data Transformations

• manipulating character variables
• manipulating numeric variables
• manipulating numeric variables based on dates
• converting variable type

Processing Data Iteratively

• performing DO loop processing
• performing SAS array processing

Combining SAS Data Sets

• match-merging two or more SAS data sets
• performing simple joins using the SQL procedure (self-study)

Learning More

• identifying additional resources

For further details: http://support.sas.com/certify/index.html

For SAS Beginners: Self-Paced e-Learning

For Beginners, who would like to learn SAS BASE Programming, http://www.sas.com/: provides Self-Paced e-Learning Courses.

1. Open this page in Internet Explorer and click on "SUPPORT & TRAINING".
2. This hyperlink will take you to another page: http://support.sas.com/
3. In the left corner of the page, you can find LEARNING CENTER: Training which when clicked would expand to:

   Self-Paced e-Learning (click here to sign up)

4. Not registered yet? Sign up now.
5. Once this form is filled, the user can see Free Tutorials
   "TUTORIAL: Getting Started with SAS(R) Free:",=> Add to Cart.
6. Now, click onYour Cart Symbol on Top Right corner...
7. Then Checkout & go Back to the Self-paced e-Learning home page and start learning the courses.

This blog:

"welcome to SAS world": http://learningworld-baithi.blogspot.com/ is also an useful link. Few interesting topics include: SAS Clinical Questions & SAS Programming

SAS: Numeric conversion of variables containing special characters and alphabets

1. Sometimes, a programmer have to convert few lab results (variable: which are in character) to numeric form.
2. These variables may contain numbers(123456789.) as well as special characters(*/()*&%$,:'+-<>") and alphabets.
3. In such case, the following code does the numeric conversion of that variable:

if indexc(result,"ABCDEFGHIJKLMNOPQRSTUVWXYZabcdefghijklmnopqrstuvwxyz*/()*&%$,:'+-<>") = 0 and result ne " " then do;

numericresult=input(result,best.);

end;

This is how I started coding......... in SAS

data marriedlife;
input motherinlaw sisterinlaw;
datalines;
1220000 560000
;
run;
***** deriving husband *******;
data husband_temp;
set marriedlife;
if motherinlaw ne . and sisterinlaw ne . then do;
husband = motherinlaw + sisterinlaw;
end;
drop motherinlaw sisterinlaw;
run;

data laterinlife;
input salary pension;
datalines;
1570000 650000
;
run;
***** deriving life *******;
data mylife_permanent;
set laterinlife;
if salary ne . and pension ne . then do;
husband = salary + pension;
mylife=husband;
end;
drop husband;
run;

Just for fun ;)

Hell to Hell: A joke that all CRO employees would love to read

One politician, One thief & One CRO employee died & went straight to Hell.

Politician said:
"I miss my country. I want to call my country and see how everybody is doing there."

He called and talked for about 5 minutes, and then he asked:
"Well, devil how much I need to pay for the call????"

The devil said:
"Five million dollars".

The Politician wrote him a cheque and went back to sit on his chair.

Thief was so jealous and he started screaming:
"My turnnn! I wanna call my group members, I want to see how everybody is doing there"

He called and talked for about 2 minutes, and then he asked:
"Well, devil, how much do I need to pay for the call????"

The devil said:
"Ten million dollars".

With a smug look on his face, he made a cheque and went back to sit on his chair.

CRO employee was even more jealous & started screaming:
"I want to call my office friends, managers and partners"

He called other CRO employees and talked for twenty hours:- about job, audit files, timelines, new clients....., he talked & talked & talked,then he asked:
"Well, devil how much do I need to pay for the call????"

The devil said:
"Twenty dollars".

CRO employee was stunned & said:
"Twenty dollars Only ?????" !!!!!!!!

Devil said:
"Calling from Hell to Hell is considered as Local Call".

[Courtesy: http://m-nicky.livejournal.com/1926.html]

-

Biometrics, the final touch..... of clinical research

Biometrics department in a CRO is a place where all clinical trial data's are analyzed using software’s (like SAS). The study protocol, Case Report Forms (CRF), Statistical Analysis Plan (SAP) & mock are read by the programmers for data analysis. This data analysis involves:

I. Deriving the dataset:

For example: The raw dataset may contain two variables namely,

a) Birth date of the patient &
b) Visit date of the patient

but it may not contain a variable called: “age”.

In order to derive the variable “age” from birth date and visit date, programmer's write code [age = int ( (visitdt - birthdt) / 365.25 ) + 1;]. Like wise many other variables are derived from the raw dataset to make a derived dataset. These derived datasets make table programming much easier.

II. Listing:

Next step is the listing of data's from the derived datasets (with little or no SAS programming).

III. Tables:

Here the programmer’s subset data according to the mock.

Listings and Tables are done based on these data's:

1) Demographics
2) Patient disposition
3) Vital signs / Lab test
4) Adverse event
5) Study drug
6) Disease progression / Death
7) Efficacy

The ultimate aim of Bio (Biological) metrics (Measurement) is to find out:

1) The difference between treatment groups
2) Change from baseline to end of study and
3) Comparison of patient subsets

How to remove the deleted page from Google's cache?

Our personal information (submitted to some job search sites) could be seen in Google search. To remove it, first the page has to be deleted from the website. Even after deleting, the page might continue to remain in Google's cache (and they appear in the search result). To delete the page from Google's cache, the following link can be used....

Webpage removal request tool:

https://www.google.com/webmasters/tools/removals?pli=1

This tool is used to remove:-

• Sensitive information from Google
• Outdated or "dead" link in the Google search results
• Inappropriate webpage or image that appears in SafeSearch filtered results

Learning Basics of Clinical Trials

Online Test on "Human Participant Protections: Education for Research Teams" developed by NIH is a valuable resource for:

1. Investigators
2. Nurse
3. Data managers and
4. Statisticians

It helps the user learn:- History, Basics, Informed consent, IRB Review, Ongoing Protections and International Research in Clinical Trials

Login> http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp

List of Universities providing Clinical Research Courses

A) Institute Clinical Research India: http://www.icriindia.com/parttime.htm

ICRI
Indiranagar, Bangalore
---
B) University of Pune: http://clinicpune.org/

1. Department of Bioinformatics,
University of Pune, Pune

2. H.V. Desai Eye Hospital
Mohammad Wadi, Hadapsar, Pune

3. A335 Shivalik Enclave,
New Delhi

4. Sankara Nethralaya, 18,
College Road, Chennai

5. T John College 88/1 Gottigere,
Bannerghatta Road Bangalore
---
C) Manipal University: http://www.crra.manipal.edu/manipaladva.html

Manipal Universal Learning Pvt. Ltd
Airport Road, Bangalore

---

D) Academy for Clinical Excellence: http://www.aceindia.org/

---

Bombay College of Pharmacy,

Kalina, Santacruz, Mumbai

Y Clinical Research in India

Clinical Research is another emerging field of Life science. The word Clinical trial means “evaluation of new drug”. There are different stages in Drug discovery which are listed as below:

• Drug Target Identification and Validation (Target is a biological molecule which plays an important role in the genesis or development of an illness)
  
  

• Developing Leads from Hits, Lead Optimization and Development ('Hit' is a chemical compound that shows activity in primary screen and 'Lead' is a compound with confirmed activity that warrants development)

• Drug Development Process: This process includes- Chemistry and synthesis of drug molecules, In vitro and animal model efficacy, Defining the appropriate dose, Defining the right animal models, In vivo dosage, Pre- clinical drug development stage, Nonclinical drug development stage, Clinical drug development stage, Manufacturing & Filing an Investigational new drug Application
  
  In the above mentioned drug development process, the Clinical drug development stage i.e., the clinical trials is an expensive processes which involve 4 phases
  
  · Phase 1 Safety and Tolerance Study - (20 to 30 healthy volunteers are involved in the study to check for safety & dosage)
  
  · Phase 2 Efficacy Studies - (100 to 300 patient volunteers are involved to check for efficacy & side effects)
  
  · Phase 3 Definitive Safety and Efficacy Studies - (1000 to 5000 patient volunteers are involved for monitoring reactions to long term drug use)
  
  · Phase 4 studies – (are done once the drug has received market approval)
  
  It takes about 15 years and $800 million dollars for researchers to find out a single drug but the cost of conducting the clinical research in India would be quite lesser because India provides number of well trained life science graduates & other required facilities at a lower cost.