StemCell Therapy

U.S. Supreme Court, ruling allows shareholders to sue Pharma and biotechnology companies for failing to report adverse drug events/ dangerous side effects.

Maker of homeopathic remedies Matrixx Initiatives, was sued by investors once it came to know their marketed nasal spray linked to a string of instances in which people using the treatment lost their sense of smell. The adverse events were reported back to the company by several medical professionals and patients, but never amounted to a statistically significant group. Matrixx argued it wasn’t responsible for reporting scattered and unreliable anecdotal evidence of adverse events. But the supremed court said No

http://www.bloomberg.com/news/2011-03-22/drugmaker-investor-lawsuits-backed-by-u-s-supreme-court-4-.html

Compare that to the Indian Law System

Madras High Court in India allowed a stay on immediate withdrawal of drugs banned  due to Severe Side Effects. The  pediatric doses of pain reliever nimesulide and anti-cold medicine phenylpropanolamine banned in  market due to harmful side effects, Indian Drugs Manufacturers Association & Confederation of Indian Pharmaceutical Industries put revenue loss to industry above safety of patients & managed to get a reversal of the ban.

http://www.business-standard.com/india/news/hc-stayimmediate-withdrawalbanned-drugs/429458/

A new survey of 500+ clinical research site professionals outlines the  impact of complex, clinical trials in clinical trial sites. The survey focused on 3-year trial trends and found key challenges in subject recruitment/retention and tracking and reporting data. Increased complexity also impacted trial financials– especially negotiating contracts and managing profitability.

The December, 2010 survey was conducted among investigators, study coordinators and other clinical site professionals from large organizations, such as Mayo Clinic and Johns Hopkins, hospitals like Rush Presbyterian and the Hospital for Sick Children, as well as multi-specialty and private practices. Clinical Research Site Training (CRST), conducted the survey.

Analysis of the survey findings shows that

• 66% of large organizations report an increase in trials conducted
• 60% of trial sites report increasing difficulty in managing trial profitability
• 40% report increasing difficulty in recruiting and retaining subjects
• Training remains a major issue, even though over 50% report an increase in training
• 80%+ of nurses want more QA training
• 60%+ of all respondents want more FDA Audits training

The survey also explored sites’ Web use for work information. In spite of increased specialized Web content about the clinical research site “world”, awareness and usage were both relatively low.

• Google (or other search sites) was the primary information tool
• Only the NIH and Clinical Trial Network sites have over 50% awareness among all site professionals
• Usage of major specialized sites averaged less than 40% for nurses and less than 20% for doctors

CRST suggest that clinical research sites should:

• Increase training on financial management, site QA, subject recruitment/retention and FDA inspections;
• Manage the convergence of increased and more complex trials by improving both new staff recruitment and experienced staff retention;
• Reach out on the Web for new/improved ways of working from both formal information sites and clinical research site communities.”

Full results of the survey are available on the CRST website http://www.crstnet.com

Contacts

CRST
Lester Levine, 484-798-7503
President
Fax: 215-477-2522
lester.levine@crstnet.com

Dr. Pauline Chen in the NY Times reports that “When Patients Share Their Stories, Health May Improve”. HC Catalyst uses the same methodology to increase patient adherence to prescription medicines.

hcCatalyst Adherence Driver uses patients to motivate other patients to stay adherent. And, we do this without remunerating, scripting or training. It’s genuine and without the liability issues associated with paid or trained spokespersons.

Details on http://www.hccatalyst.com/solutions.html

A new survey of 500+ clinical research site professionals outlines the  impact of complex, clinical trials in clinical trial sites. The survey focused on 3-year trial trends and found key challenges in subject recruitment/retention and tracking and reporting data. Increased complexity also impacted trial financials– especially negotiating contracts and managing profitability.

The December, 2010 survey was conducted among investigators, study coordinators and other clinical site professionals from large organizations, such as Mayo Clinic and Johns Hopkins, hospitals like Rush Presbyterian and the Hospital for Sick Children, as well as multi-specialty and private practices. Clinical Research Site Training (CRST), conducted the survey.

Analysis of the survey findings shows that

• 66% of large organizations report an increase in trials conducted
• 60% of trial sites report increasing difficulty in managing trial profitability
• 40% report increasing difficulty in recruiting and retaining subjects
• Training remains a major issue, even though over 50% report an increase in training
• 80%+ of nurses want more QA training
• 60%+ of all respondents want more FDA Audits training

The survey also explored sites’ Web use for work information. In spite of increased specialized Web content about the clinical research site “world”, awareness and usage were both relatively low.

• Google (or other search sites) was the primary information tool
• Only the NIH and Clinical Trial Network sites have over 50% awareness among all site professionals
• Usage of major specialized sites averaged less than 40% for nurses and less than 20% for doctors

CRST suggest that clinical research sites should:

• Increase training on financial management, site QA, subject recruitment/retention and FDA inspections;
• Manage the convergence of increased and more complex trials by improving both new staff recruitment and experienced staff retention;
• Reach out on the Web for new/improved ways of working from both formal information sites and clinical research site communities.”

Full results of the survey are available on the CRST website http://www.crstnet.com

Contacts

CRST
Lester Levine, 484-798-7503
President
Fax: 215-477-2522
lester.levine@crstnet.com

Dr. Pauline Chen in the NY Times reports that “When Patients Share Their Stories, Health May Improve”. HC Catalyst uses the same methodology to increase patient adherence to prescription medicines.

hcCatalyst Adherence Driver uses patients to motivate other patients to stay adherent. And, we do this without remunerating, scripting or training. It’s genuine and without the liability issues associated with paid or trained spokespersons.

Details on http://www.hccatalyst.com/solutions.html

AstraZeneca Pharmaceuticals LP (NYSE: AZN) and HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc. (NYSE: WLP), announced a collaborative agreement to conduct real-world studies designed to determine how to most effectively and economically treat disease

Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess treatment impact on hospital length of stay, readmissions, overall health status, cost of care and other key evidence-based outcomes.

A leader in health outcomes research, HealthCore maintains the largest data environment in the nation. HealthCore’s near real-time, fully-integrated data environment combines medical, pharmacy, laboratory results and other information drawn from 36 million enrollees in local Blue Cross and/or Blue Shield plans with concentrated populations in 16 states.

AstraZeneca Pharmaceuticals LP (NYSE: AZN) and HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc. (NYSE: WLP), announced a collaborative agreement to conduct real-world studies designed to determine how to most effectively and economically treat disease

Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess treatment impact on hospital length of stay, readmissions, overall health status, cost of care and other key evidence-based outcomes.

A leader in health outcomes research, HealthCore maintains the largest data environment in the nation. HealthCore’s near real-time, fully-integrated data environment combines medical, pharmacy, laboratory results and other information drawn from 36 million enrollees in local Blue Cross and/or Blue Shield plans with concentrated populations in 16 states.

Ever heard of people getting obnoxious amount of money to conduct research or get a PhD for pointless research. Thats what came to my mind when I first came across this news from IBM.

Just remind these were some of the winning ideas that funded by Government in US for Research papers and PhDs

1. the National Science Foundation once gave $100K grant to research why American players go to greater lengths to mod the popular MMO than do Chinese WoW players.

2.  Pressures Produced When Penguins Pooh — Calculations on Avian Defaecation”, Polar Biology, 2004

3. Suicide rates are linked to the amount of country music played on the radio, , Medicine, 2005

4. Rats can’t always tell the difference between Japanese spoken backwards and Dutch spoken backwards, winner, Linguistics, 2007

 As much as I stand to loose a chance to get a job at IBM by this post, its  so hard not to think loud, and ask IBM what the heck was wrong with your brains, when you made the decision to patent the patent.

 The Original Post Pasted from http://www.tomshardware.com/news/ibm-patents-the-patent,11868.html

IBM Files Application to Patent The Patent Process

   Reading through IT patents these days requires patience and tolerance. When you can patent common sense, there is clearly something wrong with the system. But as long as no changes are being made, you are inviting people to exploit what is available and IBM has just demonstrated what may be possible, if one of their most recent patent applications is accepted by the USPTO.

OFFICE OF , INSPECTOR GENERAL of US Department of Health and Human Services, released a report on the national incidence of adverse events for hospitalized Medicare beneficiaries, the preventability of such events, and associated costs to Medicare.

The report released last month month found that one in seven of the patients experienced an adverse event such as excessive bleeding, a hospital-acquired infection or aspiration pneumonia. Those events, both preventable and not preventable, led to about 180,000 deaths a year.

The complete report available at

http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf

The implementation of this platform enables rapid study set-up, automated CRF generation and better study recruitment and communication tools for general and special populations. Mobile workstations allow for rapid data entry and data is captured directly using bar codes and interfaces to medical equipment, such as blood pressure monitors. The Initiator platform also interfaces with the Company’s LIMS, as well as its diagnostic laboratory software and investigational drug management system.

Detailed PR available at PharmNet website

http://phx.corporate-ir.net/phoenix.zhtml?c=234619&p=irol-newsArticle&ID=1506686&highlight=

Sanofi-Aventis and Oxford University have entered into an agreement with INDOX, an academic oncology network to conduct oncology clinical and translation research in India.

The company said that through this partnership, Sanofi-Aventis will have access to experience and expertise of India’s top oncologists which will help the company in conducting clinical research. “The collaboration between sanofi-aventis, Oxford University and the Indian Cancer Centers fosters a model for academic researchers and industry to work together for the benefit of patients,” said Debasish Roychowdhury, MD, Senior Vice President, Head of Oncology, sanofi-aventis.

Sanofi-Aventis said that the company will provide financial assistance to Oxford University to manage INDOX’s eigh cancer reseach centres in India. The university, on its part, will provide training and support to investigators and reseach coordinators to help in carrying out the research.

INDOX is a partnership between Oxford University and India’s top eight cancer research centres in India.

Vicki Phelan, Managing Director, Pharmaceutical and Life Sciences Practice
with Stan Lepeak, Managing Director, Global Research

Trends in the life sciences and pharma research and development  outsourcing (RDO)

The complete report is available at http://goo.gl/MgVBu

Oracle Siebel CRM is the base application behind Oracle’s Siebel CTMS.

Prepackaged OBIEE Applications does not have a module for Clinical Analytics and so there is a need to develop a complete custom OBI application in order to accomplish the requirements. This was untill Oracle has introduced Oracle Clinical Development Analytics (CDA) which is based on OBIEE+

Oracle CDA includes prebuilt data models, prebuilt Extract-Transform-Load programs sourcing from Oracle Clinical / Remote Data Capture and Oracle’s Siebel Clinical Trial Management System

Business Intelligence can be deployed in several Core functions

• Protocol Design and Study Start-Up
• Patient and Investigator Recruitment
• Clinical Trial Management
• Clinical Data Management
• Data Analysis
• Clinical Supplies
• Regulatory and Safety

Nonclinical Use of  Business Intelligence in Clinical Trial
There are a number of ways in which business intelligence as a technology platform can be used to support the pharmaceutical value chain. There is ample evidence to show how business intelligence has been used successfully in a number of areas including:

• Sales and Marketing
• Manufacturing
• Finance
• Human Resources
• Information Services
• Executive and Portfolio Management

Clinical Use  of  Business Intelligence in Clinical Trial
Within clinical research, the strongest use of technology is in pre-clinical research, clinical, statistical programming and supporting other groups such as:

• Data management (patient profiles)
• Medical writing
• Finance
• Project management
• Patient registries and post-marketing surveillance

Without CDA an OBIEE architect needs to understand CRM data model and also the actual business process flow of a CTMS application.It is observed that usually there is a customization to an extent of 25% on the CRM application.

Original Old Article on OBIEE for CTMS which was the only Business Intelligence solutions for Clinical trial management before Oracle announced CDA is Available at http://www.obieetalk.com

Requirements gathering sessions must be interactive with group of SME’s, Team of members from business, project sponsors to mitigate any risk of
slipping the time lines. It is recommended to plan for regular client reviews and approvals of every build to avoid any gaps in the expectations by the client .

At a high level the reporting requirements may include tracking budget and finance, clinical trials, activities, investigators,Initiations, enrollments, expiration’s, terminations. Cross dimensional hierarchies from Program to Protocol to Site to Subject is commonly desired.

Major dimension tables specific to CTMS includes Program, Protocol,Site,Subject, application, Investigator. Other common dimensions include Accounts, Contacts, Activities, Time, Geography,product, etc.

Here is a screen shot of a sample rpd for CTMS

one of the very few interesting article by Microsoft Engineers on Clinical Research Industry. Certainly interesting as it is written by none other than      Les Jordan-CTO, Life Sciences Industry Unit at Microsoft . Microsoft and IBM had much longer and deepr association with Lifescience/Healthcare/Bioinformatics industry than Oracle.

But I love to see microsoft grow beyond Sharepoint for Clinical Research and the BioIT alliance. Also love to ask microsoft what is the current status of some of those applications mentioned in the blog by Les, Especially the Microsoft Clinical Trial Initiation solution

Original article from microsoft website

Interesting how weeks become months when you’re writing and updating blogs.  This CTMS project certainly hasn’t gone away, but it did go on a bit of a hiatus while my “day job” intervened.  Enough excuses.  Mea Culpa.  On to the fun!

As we discussed in the previous post, the key to a clinical trials management system is thinking of it in terms of a project – after all, the people who run the clinical trial think of it in terms of a project, and it is measured in project management terms, so why not treat it that way from an architectural point of view?

A second and equally important “requirement” is one that we are increasingly seeing as an industry trend: having EDC (Electronic Data Capture) functionality and CTMS (Clinical Trials Management System) functionality in the same system, or at the very least having EDC and CTMS closely integrate and interoperate.

The clinical trials world of today is fairly fractured.  Think of all the different systems – often standalone systems – that are used by Life Science organizations:

• EDC – Electronic Data Capture
• CTMS – Clinical Trials Management Systems
• CLIP – Clinical Investigator Portals
• Project – Clinical Trials Project Management
• Analysis – OK, it’s SAS, but how do you get the data there?  What about real-time analytics?
• IRB & DSMB – Outside organizations with their own management systems, like a Click Commerce Research Compliance Automation solution?

What if you could have a system that gets close to doing all of that – or at least being able to manage all of it – through one interface?  How much would that save in training costs, integration costs, and implementation costs?

Well – that’s the vision.  Here’s how we pull it off:

1. Start with Microsoft Office SharePoint Server 2007 and SQL Server 2008 as the foundation to build upon.
2. As discussed in the last post, we’ll use Microsoft Office Project Server as a way to organize the information and provide us with a trial specific taxonomy, along with roll-up of reporting metrics.
3. To cover the EDC aspects, we’ll utilize Microsoft Office Forms Server 2007 – which is a web facing InfoPath solution – to handle data entry and front-ending the workflow for data checks, etc.

EDC forms in Forms Server can even handle digital signatures (with compliance and security being the subject of a future post) inside the InfoPath forms.  This has implications for those organizations that are involved with SAFE BioPharma (worth checking out).

The beauty of all of this is that it is all Web Service enabled, which means that you have easier integration mechanisms with existing analysis and EDC systems:

• SAS – With integration with .NET, SOAP, and Web Services.
• Medidata – We’ve demonstrated use of their Web Services API module that utilizes CDISC.
• Perceptive Informatics – At the DIA annual meeting a couple years ago, we did a demonstration using DataLabs (now Perceptive) and InfoPath integration, using Web Services and about 5 lines of code!
• EHR/EMR Integration – While it is still on the horizon, I think it is getting closer.  Check it out.

Resources to get you started:

• Configuring SharePoint for 21 CFR Part 11 Compliance
• Project Server and Office SharePoint Server 2007 Integration
• Project Server Architecture and Programmability
• InfoPath Forms Server Form Template Authoring
• Microsoft Clinical Trial Initiation solution

Finally – there are other organizations and software vendors that are thinking along these lines.  Check out the following solutions:

• A solution in place in the US Department of Veteran Affairs
• TENALEA – Trans European Network for Clinical Trials Services
• Transenda – An Office & Project based CTMS system
• StreamLogic – A Project Based CTMS system

Next up in this series:

• Using MOSS templates for maintaining Part 11 compliance
• Extranets & Identity Management
• Architecture Diagrams & Screen shots
• Validation and compliance

I had posted last month about the Pegasystem pharmacovigilance solution.

Pega Systems the industry leader in Business Process Management (BPM) software solutions, released a Pharmacovigilance case processing software.

Pega has experience in clinical trial space, specifically in Clinical Trial Management. The solution is designed for rapid deployment to quickly leverage existing adverse event processing rules and requirements and can produce specialized documentation to help ensure compliance in a validated environment.

I have not come across any new updates after that. But apparently Accenture  has acquired Knowledge Rules, Inc., a Philadelphia-based consulting company that focuses exclusively on implementing and integrating business solutions using Pegasystems’ Business Process Management (BPM) software.

Accenture has a very large Pharmacovigilance division serving several large pharmaceutical companies. It would not be very suprising if Accenture roles out the BPM software for their pharmacovigilance services.

I think that is a possibility because Accenture  has announced plans to use the applications for all its Fortune 500 customers.

I would predict that United Health Group could be one of those customers as they are an existing customer of Pega.

Speaking of which Pega sounds like an attractive target Oracle can acquire

Ever heard of people getting obnoxious amount of money to conduct research or get a PhD for pointless research. Thats what came to my mind when I first came across this news from IBM.

Just remind these were some of the winning ideas that funded by Government in US for Research papers and PhDs

1. the National Science Foundation once gave $100K grant to research why American players go to greater lengths to mod the popular MMO than do Chinese WoW players.

2.  Pressures Produced When Penguins Pooh — Calculations on Avian Defaecation”, Polar Biology, 2004

3. Suicide rates are linked to the amount of country music played on the radio, , Medicine, 2005

4. Rats can’t always tell the difference between Japanese spoken backwards and Dutch spoken backwards, winner, Linguistics, 2007

 As much as I stand to loose a chance to get a job at IBM by this post, its  so hard not to think loud, and ask IBM what the heck was wrong with your brains, when you made the decision to patent the patent.

 The Original Post Pasted from http://www.tomshardware.com/news/ibm-patents-the-patent,11868.html

IBM Files Application to Patent The Patent Process

   Reading through IT patents these days requires patience and tolerance. When you can patent common sense, there is clearly something wrong with the system. But as long as no changes are being made, you are inviting people to exploit what is available and IBM has just demonstrated what may be possible, if one of their most recent patent applications is accepted by the USPTO.