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

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How to improve R&D productivity: the pharmaceutical industry’s grand challenge

 

 

Scott Stern Kellogg School of Management speaks about “New Drug Development: From Laboratory to Blockbuster to Generic,”

Scott Stern, Associate Professor, Kellogg School of Management, speaks on the topic of, “New Drug Development: From Laboratory to Blockbuster to Generic,” at the Judicial Symposium on The Pharmaceutical Industry: Economics, Regulation, and Legal Issues, hosted by the Northwestern Law Judicial Education Program

Health Council of Canada says some prescription drugs approved for use in Canada may be less safe than consumers think, due to poor Pharmacovigilance/Post Market Surveillance rules

Canada’s Food and Drugs Act relies on drug companies to submit adverse reaction reports, which drug users submit if they suspect they are experiencing negative side effects. Drug users also can submit the reports directly to Health Canada, but it still leaves the government to rely on outside parties to report problems.

In 2009, Health Canada received 27,496 adverse reaction reports — a number that has increased steadily over time. Health Canada needs the power to require pharmaceutical companies to conduct more post-market monitoring and to share the results, Abbott said. The council also would like to see the federal government hold the power to impose penalties for companies that do not comply.

Health Canada is already modernizing its regulations to allow for stronger monitoring after the drug goes to market. The government also has established a Drug Safety and Effectiveness Network to study the safety of drugs in the market.

The Canadian pharmaceutical industry welcomes modernized regulation, said Mark Ferdinand, vice-president of police research and analysis for RX&D, the pharmaceutical industry association in Canada.

However, Ferdinand said consumers should recognize that there is already a formal, rigorous post-market reporting system in place.

“No one has any interest in seeing a drug used inappropriately in the real world. A lot of people have invested a lot of time, effort, certainly money … to ensure what they are producing and what they are providing to patients is safe and effective,” he said.

Ferdinand said drug safety often depends on the way medicine is prescribed. He said it has to be “the right medication, for the right person, at the right time.”


Chinese drug discovery market predicted to grow 23% per annum

China’s health and medical industry is advancing rapdily within genomics, combinatorial chemistry and high-throughput screening, China has been recognised as an important location to which drug discovery is being outsourced.

The Chinese drug discovery market reached US$315.0 million in 2009 and is predicted to expand at a compound annual growth rate of 23% from 2009 to 2016.

China has opportunities for scientific expertise and complete infrastructure, which are important for drug discovery activities. Separate from India, China is also viewed as a profitable market, this will assist pharmaceutical companies improve drug finding at a reasonable cost.

 

Eli Lilly CIO Michael Heim says Lilly will increase use of cloud computing in clinical data management

Eli Lilly’s CIO Michael Heim says that the drug giant’s right to know where in the cloud its data resides, and to know the provider’s disaster recovery plans are chief issues that will drive the use of cloud computing in clinical data within drug discovery and development projects.

An interview with Michael Heim is available at InformationWeek

Clinical approval success highest for smallest firms among the top 50 Pharmaceutial companies

The top 10 pharmaceutical companies out of the world’s top 50 have lower estimated overall clinical approval success rates than do smaller firms in that group, but nonetheless appeared to have some R&D productivity advantages, according to a new study completed by the Tufts Center for the Study of Drug Development.

Despite experiencing lower overall clinical success rates, the top 10 firms terminated a greater proportion of their failures in early stage clinical testing, compared to the other 40 companies in the group, the study found. Failing early lets developers redirect resources into other projects and avoid more costly later stage failures.

While the very largest firms had lower approval success rates, they did make the decision to terminate earlier in the development process, which can help improve productivity of their new product pipelines.

The study was based on 1,734 compounds that entered clinical testing between 1993 and 2004, for the top 50 companies, which had 2006 revenues of more than $1 billion. The timeframe allowed for analysis of the full development cycle. Clinical approval success rate is the share of investigational new compounds entering clinical testing that eventually obtain FDA marketing approval.
The study, reported in the September/October Tufts CSDD Impact Report, released today, also found that:
1.  Small molecules accounted for 85% of the drugs that entered the clinical pipelines of top 50 pharmaceutical firms in the 1993-04 period.
2. Large molecule clinical approval success rates outpaced small molecules by nearly 2:1 for each top-50 pharma size group examined.
3. Across all top company size groups, transitioning compounds from Phase II to Phase III was a substantial hurdle.

the study is available at http://csdd.tufts.edu/

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