Follow us on




Q of the week

Q: How Do You Get Shingles?

Get the Answer: 

Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

 Forums
Welcome Guest   [Register]  [Login]
EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 20:12:20
Managing Clinical Trials   by  on 2010-07-16 00:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 18:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 17:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 17:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 09:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 09:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-21 03:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-19 07:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-19 06:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 15:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-05 04:52:16
CONSORT III (2010)   by  on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 20:12:14
 Subject :The Importance of Strong Study Feasibility on Patient Enrollment in In.. 2009-10-15 00:24:51 
Sreedhar
Newbie
Joined: 2009-10-09 16:27:58
Posts: 3
Location
Subject :The Importance of Strong Study Feasibility on Patient Enrollment in India

The Importance of Strong Study Feasibility on Patient Enrollment in India 

In order to understand which studies will enroll in India, you have to understand disease prevalence rates first. Unfortunately, India does not currently produce wide ranging information via government or industry organizations which will provide an accurate assessment of disease prevalence and incidence. Instead, a more classic feasibility must be conducted directly through the investigative sites. Many factors including newness of some sites, cultural customs and trust require the feasibility questionnaire to be distributed in person and information gathered through an interview rather than simply sending along a form via fax or email. Using an organization with personnel across the country and with good contacts at each of the sites can make the process more efficient and often result in better data. Like in the US, enrollment projections given by Indian investigators typically need to be scaled back considerably, but often the aggregate projections are still much higher. Good feasibility data will also include the meeting frequency of each sites IRBs (some IRBs may only meet once every 2-3 months) and the related fees, also an important part of getting the study up and running quickly.

This hands-on feasibility process typically results in the selection of better sites. But far greater in importance is the need for ongoing support of each site to ensure faster enrollment. As mentioned earlier, site management companies are now assisting sponsors with placement of a full time highly trained CRC at each site to work along side the investigator, conduct chart reviews, follow up with potential patients, conduct screenings and help administer informed consent among other things. This type of day-to-day support is essential to ensuring the right patients are enrolled.

regards

Dr.sreedhar 
IP Logged
Page # 


Powered by ccBoard