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• Outdated or "dead" link in the Google search results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
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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
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C) Manipal University: http://www.crra.manipal.edu/manipaladva.html

Manipal Universal Learning Pvt. Ltd
Airport Road, Bangalore

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

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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.