Single patient Clinical Trial are not new idea, FDA did not focus since such trial canot prove the efficacy and safety of medicine over a large pool of patient with sufficient data. But I was forced to re-think after reading the article http://www.technologyreview.in/biomedicine/12537/ why cant we use the the concept mentioned in to overcome the ethical and other challenges in current mode of trials.
So I decided to ask the question to the linkedin audience http://www.linkedin.com/answers/technology/biotech/TCH_BIO/667022-9262868?browseIdx=0&sik=1272969161323&goback=.amq
- 001 F.D.A. Says Millions Got Unapproved Drugs, Should the new bioequivalence and bioanalytical guidelines for 2010, be made more stringent [Last Updated On: April 15th, 2010] [Originally Added On: April 15th, 2010]
- 002 F.D.A. Says Millions Got Unapproved Drugs, Should the new bioequivalence and bioanalytical guidelines for 2010, be made more stringent [Last Updated On: April 16th, 2010] [Originally Added On: April 16th, 2010]
- 003 GSK, MedTrust launch iPhone/iPad app for cancer trials [Last Updated On: June 11th, 2010] [Originally Added On: June 11th, 2010]
- 004 GSK, MedTrust launch iPhone/iPad app for cancer trials [Last Updated On: June 11th, 2010] [Originally Added On: June 11th, 2010]
- 005 22 Million Australian Cloud computing initiative to benefit life science researchers [Last Updated On: June 19th, 2010] [Originally Added On: June 19th, 2010]
- 006 GE Healthcare announces SaaS Electronic Medical Records Management [Last Updated On: June 19th, 2010] [Originally Added On: June 19th, 2010]
- 007 22 Million Australian Cloud computing initiative to benefit life science researchers [Last Updated On: June 19th, 2010] [Originally Added On: June 19th, 2010]
- 008 GE Healthcare announces SaaS Electronic Medical Records Management [Last Updated On: June 19th, 2010] [Originally Added On: June 19th, 2010]
- 009 Stem Cell Therapy: Age of Human Cell Engineering is Born [Last Updated On: June 25th, 2010] [Originally Added On: June 25th, 2010]
- 010 Using Stem Cells Scientists Grow a Rat Lung, Humans are Next [Last Updated On: June 29th, 2010] [Originally Added On: June 29th, 2010]
- 011 How useful would be the Single-patient clinical trials for improving the hopes of Personalized medicine [Last Updated On: August 12th, 2010] [Originally Added On: August 12th, 2010]
- 012 Life Sciences at Oracle Open World 2010 [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 013 ChIP Enrichment Analysis can speed up drug discovery [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 014 GE’s healthymagination initiative lead Smart Patient Room to improve patient safety goes live at Bassett Medical Center [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 015 The SaaS impact on solution selling for ISVs (via Inner Lining) [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 016 Oracle starts the Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 017 Life Sciences at Oracle Open World 2010 [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 018 ChIP Enrichment Analysis can speed up drug discovery [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 019 GE’s healthymagination initiative lead Smart Patient Room to improve patient safety goes live at Bassett Medical Center [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 020 The SaaS impact on solution selling for ISVs (via Inner Lining) [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 021 Oracle starts the Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs [Last Updated On: October 11th, 2010] [Originally Added On: October 11th, 2010]
- 022 70% of Pharmaceutical organisations outsource at least one PV activity. This level is expected to increase to 80% by 2012 [Last Updated On: November 7th, 2010] [Originally Added On: November 7th, 2010]
- 023 Insurance coverage for healthcare IT software, to protect healthcare IT companies from damages inflicted by their software [Last Updated On: November 7th, 2010] [Originally Added On: November 7th, 2010]
- 024 India announce Heart Surgery for $1000 USD [Last Updated On: November 7th, 2010] [Originally Added On: November 7th, 2010]
- 025 Indian Healthcare IT market & Oracle’s presence in Indian Healthcare [Last Updated On: November 7th, 2010] [Originally Added On: November 7th, 2010]
- 026 70% of Pharmaceutical organisations outsource at least one PV activity. This level is expected to increase to 80% by 2012 [Last Updated On: November 7th, 2010] [Originally Added On: November 7th, 2010]
- 027 Insurance coverage for healthcare IT software, to protect healthcare IT companies from damages inflicted by their software [Last Updated On: November 7th, 2010] [Originally Added On: November 7th, 2010]
- 028 India announce Heart Surgery for $1000 USD [Last Updated On: November 7th, 2010] [Originally Added On: November 7th, 2010]
- 029 Indian Healthcare IT market & Oracle’s presence in Indian Healthcare [Last Updated On: November 7th, 2010] [Originally Added On: November 7th, 2010]
- 030 Harvard Medical Schools new automated safety surveillance system provides faster early warnings in the postmarket evaluation of medical device safety [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 031 SalesForce.com partner introduces CRM for clinical trial management on Force Platform [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 032 Widespread fraud in the Clinical Trial of Drugs is pervasive event in United States [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 033 Scott Stern Kellogg School of Management speaks about “New Drug Development: From Laboratory to Blockbuster to Generic,” [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 034 collaborative clinical trials management software for Central Laboratories [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 035 MNC Pharma tries to capture the $1.9 billion Indian OTC market by selling Drugs through India’s 170000 post offices [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 036 Clinical Trial and Pharmacovigilance process automation [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 037 Microsoft in Clinical Trials Management System (CTMS) and Electronic Data Capture (EDC) [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 038 Oracle Business Intelligence Enteprise Edition (OBIEE) for Clinical Trial Management System (CTMS) [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 039 trends in the life sciences and pharma research and development outsourcing (RDO) [Last Updated On: November 29th, 2010] [Originally Added On: November 29th, 2010]
- 040 Sanofi-Aventis ties up with Oxford Univ for oncology research in India [Last Updated On: December 17th, 2010] [Originally Added On: December 17th, 2010]
- 041 PharmaNet unveils touch screen capable data capture platform for Phase I Clinical Trials [Last Updated On: December 17th, 2010] [Originally Added On: December 17th, 2010]
- 042 Adverse Events in Hospitals- United States Department of Health Report slams current measures in US hospitals [Last Updated On: December 23rd, 2010] [Originally Added On: December 23rd, 2010]
- 043 IBM Files Application to Patent The Patent [Last Updated On: January 9th, 2011] [Originally Added On: January 9th, 2011]
- 044 How to improve R&D productivity: the pharmaceutical industry’s grand challenge [Last Updated On: February 7th, 2011] [Originally Added On: February 7th, 2011]
- 045 Clinical Trial and Pharmacovigilance process automation [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 046 Microsoft in Clinical Trials Management System (CTMS) and Electronic Data Capture (EDC) [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 047 Oracle Business Intelligence Enteprise Edition (OBIEE) for Clinical Trial Management System (CTMS) [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 048 trends in the life sciences and pharma research and development outsourcing (RDO) [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 049 Sanofi-Aventis ties up with Oxford Univ for oncology research in India [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 050 PharmaNet unveils touch screen capable data capture platform for Phase I Clinical Trials [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 051 Adverse Events in Hospitals- United States Department of Health Report slams current measures in US hospitals [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 052 IBM Files Application to Patent The Patent [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 053 How to improve R&D productivity: the pharmaceutical industry’s grand challenge [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 054 AstraZeneca Announce Real-World Evidence Data Collaboration [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 055 AstraZeneca Announce Real-World Evidence Data Collaboration [Last Updated On: February 14th, 2011] [Originally Added On: February 14th, 2011]
- 056 Medication adherence improves, When Patients Share Their Stories [Last Updated On: March 13th, 2011] [Originally Added On: March 13th, 2011]
- 057 Questions for the CRO [Last Updated On: March 13th, 2011] [Originally Added On: March 13th, 2011]
- 058 Clinical Research Sites Struggle With Increasing Trial Complexity yet most depend on, Google (or other search sites) as the primary information tool [Last Updated On: March 13th, 2011] [Originally Added On: March 13th, 2011]
- 059 Medication adherence improves, When Patients Share Their Stories [Last Updated On: March 13th, 2011] [Originally Added On: March 13th, 2011]
- 060 Questions for the CRO [Last Updated On: March 13th, 2011] [Originally Added On: March 13th, 2011]
- 061 Clinical Research Sites Struggle With Increasing Trial Complexity yet most depend on, Google (or other search sites) as the primary information tool [Last Updated On: March 13th, 2011] [Originally Added On: March 13th, 2011]
- 062 Law of the land can help or destroy the Pharmacovigilance system [Last Updated On: March 27th, 2011] [Originally Added On: March 27th, 2011]
- 063 Law of the land can help or destroy the Pharmacovigilance system [Last Updated On: March 27th, 2011] [Originally Added On: March 27th, 2011]
- 064 Indian Government’s new dose of strong medicine to bring cheers to Foreign Pharma CEOs who cut their teeth by struggling to convince Indian pharma to change sales practices [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- 065 Indian Government’s new dose of strong medicine to bring cheers to Foreign Pharma CEOs who cut their teeth by struggling to convince Indian pharma to change sales practices [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- 066 Drug Reps Soften Their Sales Pitches, as pharma learns from Disney [Last Updated On: January 15th, 2012] [Originally Added On: January 15th, 2012]
- 067 Drug Reps Soften Their Sales Pitches, as pharma learns from Disney [Last Updated On: January 15th, 2012] [Originally Added On: January 15th, 2012]
- 068 Oracle Unveils Oracle® Health Sciences Omics Data Bank as Part of Oracle Health Sciences Translational Research Center [Last Updated On: January 29th, 2012] [Originally Added On: January 29th, 2012]
- 069 Oracle Unveils Oracle® Health Sciences Omics Data Bank as Part of Oracle Health Sciences Translational Research Center [Last Updated On: January 29th, 2012] [Originally Added On: January 29th, 2012]
- 070 One Way to Teach Your Boss About Social Media [Last Updated On: February 12th, 2012] [Originally Added On: February 12th, 2012]
- 071 “The Banks Can Do It, Why Can’t Hospitals?” [Last Updated On: February 12th, 2012] [Originally Added On: February 12th, 2012]
- 072 Internet on any Display Device, or internet on TV at low cost can it transform Healthcare or Clinical Research [Last Updated On: February 12th, 2012] [Originally Added On: February 12th, 2012]
- 073 Is Life Sciences the New Frontier for Analytics? [Last Updated On: February 12th, 2012] [Originally Added On: February 12th, 2012]
- 074 Internet on any Display Device, or internet on TV at low cost can it transform Healthcare or Clinical Research [Last Updated On: February 12th, 2012] [Originally Added On: February 12th, 2012]
- 075 Is Life Sciences the New Frontier for Analytics? [Last Updated On: February 12th, 2012] [Originally Added On: February 12th, 2012]
- 076 bluebird bio Appoints David Davidson, M.D., as Chief Medical Officer [Last Updated On: February 17th, 2012] [Originally Added On: February 17th, 2012]
- 077 SOCIAL CRM and its Impact on Pharmaceutical Industry [Last Updated On: February 19th, 2012] [Originally Added On: February 19th, 2012]
- 078 privacy controlled social networking to connect patients with caregivers [Last Updated On: February 19th, 2012] [Originally Added On: February 19th, 2012]
- 079 SOCIAL CRM and its Impact on Pharmaceutical Industry [Last Updated On: February 19th, 2012] [Originally Added On: February 19th, 2012]
- 080 privacy controlled social networking to connect patients with caregivers [Last Updated On: February 19th, 2012] [Originally Added On: February 19th, 2012]