Novartis, Pfizer, and Eli Lilly partner for new clinical trial software platform

57% Americans would be interested in participating in a clinical trial. However, most clinical studies struggles to recruit sufficient patients. The issue has attracted a number or software as well contract service firms that specialize in clinical trial recruitment, even using social medial tools. Then there is long going debate and efforts for integrating EHR data into clinical trial and identifying potential suitable target population of patients directly from de-identified EHR data

In order to connect patients and researchers, Novartis, Pfizer and Eli Lilly and Company, are partnering in the U.S. to provide a new platform to improve access to information about clinical trials. The platform will enhance clinicaltrials.gov and is expected to be launched by early 2014 with a database of about 50 clinical research studies from the participating companies.

The new platform will provide more detailed and patient-friendly information about the trials, including a machine readable “target health profile” to improve the ability of healthcare software to match individual health profiles to applicable clinical trials.

As part of the project, patients can search for trials using their own Blue Button data. To preserve data privacy de-identified Blue Button data, used only as an “index to search,” will not be stored anywhere outside of the patient’s application.

Other sponsors of clinical research studies may upload information about their trials, while software companies develop tools to deliver this information to interested patients.

India announce new formula for compensating death during clinical trials

 India has released formula to determine quantum of compensation in cases of SAEs of deaths occurring during clinical trials

The formula is available at (http://www.cdsco.nic.in/formula2013SAE.pdf)

The Guideline is available at (http://www.cdsco.nic.in/compention.pdf)

As per the new rule the compensation is calculated as

Compensation = B * F * R/99.37

Here, B = Base amount (Rounded) which is fixed as INR 800000. This base amount has been fixed with consideration of minimum wages act.

F = Factor depending on the age of the subject as per the Annexure given, which is based on Workmen Compensation Act.

R = Risk factor depending on the seriousness and severity of the disease, presence of co – morbidity and duration of disease of the subject at the time of enrolment in the clinical trial between a scale of 0.5 to 4.0 as under:
0.50 – Terminally ill patient (Expected survival not more than 6 months)
1.0 – Patient with high risk (Expected survival between 6 to 24 months)
2.0 – Patient with moderate risk (Moderate risk if not defined)
3.0 – Patient with mild risk (Mild risk is not defined)
4.0 – Healthy volunteers or subject of no risk

Here, 99.37 is the factor for age 65 in the table of worksmen compensation act. The concept used is that the base amount INR 8,00,000 should refer to the age of 65 years which corresponds to factor 99.37.

Thus, considering an example:
If the age of the subject is 30 years, the factor F as per the factor given in the table comes to 207.98
If the subject is Healthy, R = 4.0
Thus,
Compensation = 8,00,000 * 207.98 * 4.0 / 99.37 = 6,697,554/-

However, in case of patients whose expected mortality is 90% or more within 30 days, a fixed amount of INR. 200000 should be given.

If calculations are done, the compensation amounts range from Rs. 400,000 to a maximum of Rs. 7,360,000 depending on the following factors:
a) Age
b) Risk factor

The CDSCO has still not released any clarity on the calculation of compensation amount in case of clinical trial related injury (Which does not progress to death)

Content from email by: SenseCR

Clinical Research Sites Struggle With Increasing Trial Complexity yet most depend on, Google (or other search sites) as the primary information tool

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 www.crstnet.com

Contacts

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

 

 

AstraZeneca Announce Real-World Evidence Data Collaboration

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.

 

PharmaNet unveils touch screen capable data capture platform for Phase I Clinical Trials

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 ties up with Oxford Univ for oncology research in India

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.

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

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

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