Part 2: Virtual Clinical Trial - A Breakthrough in Clinical Trial Industry


In continuation to my earlier post on Virtual Clinical Trial, I came across recent news, that Pfizer will re-launch virtual trial programme in 2013 (Click the link for detailed information) which focus on recruiting and communicating with patients entirely through internet. After a pilot virtual clinical trial programmed in US it will now re-launch it in EU Region.

I how this time, Pfizer get a success over Virtual Clinical Trial Programme.

Just wait a sparking 2013 soon. Keep reading.

DCGI ordered to limit dose of paracetamol in Prescription Combination Products and to give Box Warning...

As per the 59th meeting of DTAB (Drug Technical Advisory Board) on 24th June, 2011 at New Delhi, it was considered to limit the dose of paracetamol in prescription combination products and to give box warning for its liver toxicity.

A notification issued by DCGI Dated 23.09.2011, stated that proposal was based on a news release by USFDA on 13.01.2011, it had directed manufacturers of prescription combination products in USA containing Acetaminophen (paracetamol) to limit the content of Acetaminophen no more than 325mg in tablet or capsule alongwith inclusion of a box warning highlighting the potential for severe liver injury and a warning of potential of allergic reactions to be added to the label of all prescription combination product containing Acetaminophen.  

Regulatory Impact to Manufacturers:

All prescription combination products having paracetamol dose above 300mg per unit dose

Changes need to make:

1.       Reduce Paracetamol content to or below 325mg per unit dose
2.       Include Label warning for its liver toxicity

Implementation Period:

Government allowed higher dose will be phased over 3 years to avoid shortage of pain medications to patients.

Your Valuable Comments will be the driving force to encourage me to post more.

Thanks.

Virtual Clinical Trial – A Revolutionary Breakthrough in Clinical Trial Industry

Conducting clinical trials in a virtual environment is not a dream now. Using patients virtually in clinical trails will be possible through information and communication technologies available today. Through virtual clinical trials, it will be possible for patients to participate in clinical trials without making a visit to physical places. Securing patient’s consent virtually through video/multimedia and online testing will be possible soon. Clinical Investigators will send all study drugs to patient’s home instead of dispensing it at clinical site. Investigator will manage the study reports remotely, and share clinical trial data with patients, making them enable to add data to their personal health records.

Simulating clinical trails on computers can forecast their results, potentially optimizing drug development and saving the pharmaceutical industry billions.1

Recently, Pfizer announced that it is conducting the first-ever randomized clinical trial under an investigational new drug (IND) application that manages study participation entirely using electronic tools and allows patients to participate in the clinical trial regardless of their proximity to clinical sites. The pilot project, initiated following review from the U.S. Food and Drug Administration (FDA), uses mobile phone and web-based technology to collect necessary data for the trial without clinic visits.2

To make these virtual clinical trials successful without much hassles, several organizations work together for collaborative partnerships, like ProtonMedica and PPD joined together to introduce New Virtual Clinical Trial Training Solution.3 Previously, PPD added iPhone application to patient recruitment toolbox as part of efforts to use technology for patient recruitment and other clinical trails processes. Using the Apple iPhone and iPad application potential study participants and investigators can search a database of clinical trials. This application, social media and other technology can improve patient recruitment and other trial processes, but there is still uncertainty in this emerging areas.4

References:
  1. http://www.outsourcing-pharma.com/Preclinical-Research/Virtual-clinical-trial-technology-vindicated
  2. http://www.thestreet.com/story/11145647/1/pfizer-conducts-first-8220virtual8221-clinical-trial-allowing-patients-to-participate-regardless-of-geography.html
  3. http://www.hypergridbusiness.com/2011/03/protonmedia-to-develop-virtual-clinical-trial-training/
  4. http://www.outsourcing-pharma.com/Clinical-Development/PPD-adds-iPhone-app-to-patient-recruitment-toolbox

Excellent Move by Government of Gujarat to ban entrance tests and interviews for admission to primary schools


Once again, Mr. Narendra Modi, Chief Minister of Gujarat proved his excellent administrative skills, through immediate notification on ban of entrance tests, interviews for admissions in primary schools.
Primary schools especially of English medium usually have policy of entrance test and interview of not only student but for parents also, will be adversely impacted through the rule on ban of tests and interviews. This kind of stringent move must be a part of Gazette notification issued by government of india for rights to education bill in 2009.  

Due to this special rule, Primary schools (of all mediums and all boards) can not be allowed to interview children or their parents for admissions from the new academic session beginning June this year.

Schools can give admissions to children on the basis of first-come-first-served basis or by draw of lots. Primary education will work on a whole new set of rules from next academic year after the Gujarat government put out a notification to enforce the right of children to free and compulsory education act, 2009. The new rules apply to all school boards, including state CBSE, ISCE and others.

Private schools will have to reserve 25 per cent of their seats for underprivileged children in primary sections. This is aimed at integrating poor students into the mainstream. "All the parents should be given admission forms without any questions. Any form of capitation fee is also prohibited," the notification of February 18 says. The rule wants school to declare under what categories students are getting admissions.

Looking forward this kind of moves throughout India, will make India a powerful country, as education is most basic right of any child after food.

Welcome 2011

Dear Friends,

NEW is the YEAR,
NEW are the HOPES AND ASPIRATIONS,
NEW is the RESOLUTION,
NEW are the SPIRITS,

NEW YEAR is meant for CELEBRATIONS and SPENDING JOYOUS TIME with our LOVED ONES.

May the beauty of NEW YEAR be with you forever and your wishes of PEACE, HEALTH and HAPPINESS ring true.
NEW YEAR is the TIME
to UNFOLD NEW HORIZONS and realize NEW DREAMS,
to REDISCOVER the STRENGTH and FAITH within you,
to REJOICE in SIMPLE PLEASURES and GEAR UP for the NEW CHALLENGES.
Wishing you and your family, a truly fulfilling 2011.

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