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

Processed EHR text can be used to develop CDS tools Read more: Processed EHR text can be used to develop Clinical decision support tools with automated text processing

See on Scoop.itinPharmatics

Free text in electronic health records, with the help of natural language processing (NLP) technology, can be used to create accurate clinical decision support (CDS) tools, according to a study published this week in the Journal of the American Medical Informatics Association

See on jamia.bmj.com

Why mHealth hasn’t created an Instagram (yet)

See on Scoop.itinPharmatics

Read about why a Qualcomm Life executive says mobile health doesn’t yet have an Instagram, and why it eventually will.

See on www.medcitynews.com

Microsoft Lync Pilot Aids AstraZeneca Sales Rep, Researcher Collaboration – Health Care IT – News & Reviews – eWeek.com – eWeek Mobile

Via Scoop.itinPharmatics

Biopharmaceutical vendor AstraZeneca has launched a unified communications pilot using Microsoft Lync to improve collaboration among pharmaceutical sales reps, doctors and researchers.
Via mobile.eweek.com

American Diabetes Association to provide millions of website users medication monitoring service using Quintiles’ Digital Patient Unit -

Via Scoop.itinPharmatics

 Quintiles and the American Diabetes Association announced a strategic agreement in which Quintiles’ Digital Patient Unit will provide the Association’s millions of website users access to Quintiles’ medication monitoring service.

 

The Association’s constituents who opt in for the service will receive free safety checks of their medications to identify potential interactions and other risk factors, which are already provided to the 2.5 million registered users of Quintiles’ www.MediGuard.org. Registrants will also be eligible to participate in select direct-to-patient programs to benefit their medical conditions and advance global diabetes patient care.

 

The Association’s constituents may opt in to this service from the Association’s website www.Diabetes.org

Via www.quintiles.com

Oracle acquire cloud based clinical operations and analytics vendor ClearTrial

Via Scoop.itinPharmatics

On March 29, 2012, Oracle announced that it has agreed to acquire ClearTrial, a leading provider of cloud-based Clinical Trial Operations and analytics products that make the planning, sourcing, and tracking of clinical projects and financial performance…

Via www.oracle.com

Follow

Get every new post delivered to your Inbox.

Join 672 other followers

%d bloggers like this: