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                    D e n t a l    F o l l i c l e               

             The        Monthly     E- Journal Of  Dentistry                  Vol -  V    Number-  I V  September 2010

In this Issue:

  • Editorial

  • News

  • DentistryUnited  Ranks 8   on GOOGLE

  • Laughter - The best Medicine

  • The field of Clinical Research as an alternative career for dentists - Dr.Richard Jimris

  • Video Of The Month - Orthognathic Surgery Series

  • The New Laws .On Teeth Cleaning Five Of Them . -  Milwaukee Journal - Oct 10, 1921
     

 

Editorial :

   A recent survey into the "shape" of the Indian "graduate" dentists  in the "Silicon  Valley" of India Bangalore gave a stunning result. In a single BPO more than 400  Dentists working . A deeper study revealed that many dentists have been leaving the profession for greener pastures like Medical Transcription and Clinical research Associates. Out of all the options the CRA is something I felt , "wise" "young" "Dental brains" could revolutionaries the practices if they are placed in the right "dental materials" manufacturing companies.

Although there is nothing like "practice" , in this issue we have a very interesting paper on CRA.

I hope your enjoy this issue. 

mailto: dentistryunited at gmail dot com

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Yours truly

Dr. Syed  Nabeel

Editor of Dental Follicle & WebMaster www.DentistryUnited.com

News :

         

A chat with Arizona's dental school deans - Phoenix...

BIOLASE Announces $9 Million Order

Medline Enhances VAP Prevention Oral Care Kits With New CHG...

Lecture and Reception on New Orthodontic Technology

 

 

 

DentistryUnited @  Ranks 8 on GOOGLE

Laughter - The Best Medicine :

Patient: Doctor, what does the X-ray of my head show?

Doctor: Absolutely nothing!


 

 

                                         

 

 

The field of Clinical Research as an

 

alternative career for dentists

By Dr.Dr.R.Richard Jimris
BDS PGDCTM ( post graduate diploma in clinical trails management )
 

 

ABSTRACT

Clinical Research involves methodical and systematic study of drugs, devices, biologicals, vaccines used in the diagnosis, prevention or treatment of disease.During the process of clinical research , the health professional is treating an individual with an aim to develop an intervention for the patient of tomorrow.The purpose of this article is to enlighten dentists that they can develop an alternate career in the field of clinical research apart from attending to patients with dental ailment.

 

INTRODUCTION

Any new drug or device intended to be used on patients has to pass through various stages before reaching the market and clinical research involves the study and process of getting the new medicine for the benefit of patients.

New drug discovery begins in the laboratory with scientists of different areas together to identify cellular and genetic factors that play a role in specific diseases.Preclinical stage of drug development involves testing of an investigational drug in the lab in both in vitro and in vivo conditions to ensure that it would be safe to administer to humans.Toxicity studies in animals are conducted to identify potential risks to humans.

Clinical development is carried out in different phases consisting of :

Phase 1- these studies are designed to verify safety and tolerability of the study drug and find out the maximum tolerated dose.Testing includes observation of pharmacodynamic and pharmacokinetic properties of drug using healthy volunteers for short periods of time.

Phase 2- these studies are carried out to determine further safety and effectiveness of the investigational new drug or the study drug in treating the condition and establishes the minimum and maximum effective dose.Testing is done with upto hundreds of patients suffering from the condition the study drug is designed to treat.

Phase 3- these studies are done in large patient population to assess the efficacy and safety of an investigational drug and is compared with the one of the currently available standard treatments.

After going through these phases, the applications are submitted to regulatory agencies

( in India, the Drug controller General of India )  to obtain approval to market the new drug.

 

WHO INITIATES THESE TRIALS

This is done by a sponsor who may be an individual or a company that initiates , manages and finances a clinical study . The sponsor company provides the clinical trial documents like the protocol, case record form , informed consent form, patient record diary etc to the person responsible to conduct the study at the trial site.

 

WHO IS RESPONSIBLE TO CONDUCT THE STUDY

This is done by the investigator ( usually a medical doctor ) It is the investigator’s responsibility to understand the time and other resource demands the study is likely to make and ensure they can be made available throughout the duration of study. Good medical care of subjects ( patients who are recruited for purpose of research or trial ) should be provided by the investigator, progress report and final report should be submitted after completion of the trials.

 

WHO ASSISTS THE INVESTIGATOR IN THE TRIALS

This is done by any health professional, and includes dentists aswell.  The dentist can work as a clinical research co ordinator under the guidance of an investigator.

The clinical research coordinator or the CRC works at the trial site which can be a corporate / private or a government hospital and his role in brief are-

-identification of the RIGHT site at the right time fulfilling all the criteria set forth by clinical trial guidelines and the protocol

-should decide on the number of patients to be enrolled for a particular trial

-select an appropriate investigator for the study or trial

-should consider infrastructure available at the site like space available, equipment, laboratories, pharmacy, internet facility etc.

-negotiate with the sponsor company on the finances involved in the conduct of the trial.

-enroll patients and also retain them for the study purpose

-responsible for the entire drug accountability.

 

 

Health care professionals and dentists can work as clinical research associate also.He or she is appointed by the sponsor company and monitors the entire day to day conduct of the trial at the site, monitors the case record data and ensures that the trial is conducted in conformation to the protocol and other guidelines.

 

OTHER AREAS WHERE A DENTIST CAN WORK

The dentist can work in the field of pharmacovigilance which aims at identifying new information about adverse drug reactions and serious adverse events ( resulting in death of subjects, life threatening conditions, etc ) Great contribution can be done to assess the benefit , harm, effectiveness , risk of medicines, encouraging their safe, rational and more effective use.

 

The dentist can also work as scientific medical writer and can undertake these works-

-medical journal abstracts and articles

-advertising copy for medications

-medical education material for doctors and other healthcare professionals

-internet content for health care professionals

-prepare the clinical trial protocol etc

 

In short the sponsor company initiates a trial, the investigator conducts the trial with the help of clinical research coordinator and the data management team and gives the final report to the sponsor company and the whole process involves great amount of money and an experienced dentist can also work as project manager in carrying out the successful project and take care of the financial part of the trial aswell.

 

Global pharma companies are turning to developing countries like India, for the conduct of clinical trials due to available man power, more patients with new diseases and ofcourse the low cost involved. Astra Zeneca, Johnson and Johnson , Glaxosmithkline, Sanofi aventis are some companies into clinical trials with India.

Clinical research on drugs can go on upto 10 years and to speed up the process, quick recruitment of subjects ( patients ) is very important and India provides vast number of patients for the purpose and it is estimated that the cost can be reduced upto 60 percent when it is done in a developing country like India than the United States.

 

CONCLUSION

Well trained medical community, increased government incentives , and regulatory support for research in India is the reason to generate a revenue of 1.5 billion dollars in this year 2010

 

The major trials are in the field of oncology and diabetes medications and are successful in the major cities like Mumbai, Chennai, Bangalore but their growth in tier2 cities like Mysore is yet to reach the target.

 

REFERENCES

1.Basic principles of clinical research and methodology by SK Gupta, Institute of clinical research, Bangalore.

2.www.criteriumusa.com/clinical_research_india.php

 

About the author:

Dr.Richard Jimris is a practicing dentist in the city of Mysore at ZION DENTAL CARE, Bogadi, Mysore for the past 8 years and has obtained his pg diploma in clinical trials management from institute of clinical research, Bangalore and is credited with having understood the FDA ( food and drug administration ) process, USA and is a member of institute of clinical research, UK

 

 

VIDEO OF THE MONTH - Orthognthic Surgery Series

 

 

 

 

 

The New Laws .On Teeth Cleaning Five Of Them .

 

Milwaukee Journal - Oct 10, 1921

The Above is from the archieves of dentistry. Do read above as The old ways of cleaning have proved Inadequate......