EFPIA/PhRMA: Joint Principles for Responsible Clinical Trial Data Sharing

EFPIA/PhRMA: Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients
Media Release: July 24, 2013

Excerpt
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) today strengthened their long-standing commitment to enhancing public health by endorsing joint “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”

“Companies routinely publish their clinical research, collaborate with academic researchers, and share clinical trial information on public websites,” said Christopher Viehbacher, President of EFPIA and CEO of Sanofi. “By endorsing the Principles, biopharmaceutical companies commit to enhance these efforts by making additional information available to the public, patients who participate in clinical trials, and to qualified researchers.

Under the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.

Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data will be encouraged to publish their findings.

Companies will work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials.

The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration [FDA], European Medicines Agency [EMA], or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.

Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication….

Implementation of the commitments begins on January 1, 2014. The Principles are available at http://transparency.efpia.eu/responsible-data-sharing and http://onphr.ma/18yru3e.

http://phrma.org/press-release/EFPIA-and-phrma-release-joint-principles-for-responsible-clinical-trial-data-sharing-to-benefit-patients

GPEI Update: Polio this week – As of 24 July 2013

Update: Polio this week – As of 24 July 2013
Global Polio Eradication Initiative
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
[Editor’s extract and bolded text]
:: In Nigeria, the first circulating vaccine-derived poliovirus type 2 (cVDPV2) case of 2013 was reported, from Borno state. It is linked to cVDPV2 currently circulating in Chad. Previously, no cVDPV2 cases had been reported from Nigeria since November. See ‘Nigeria’ section for more.

Nigeria
:: One new cVDPV2 case was reported in the past week – the first in the country in 2013. Previously, no cVDPV2 cases had been reported since November 2012. This most recent cVDPV2 case had onset of paralysis on 6 June (from Borno).

:: This latest case is linked to cVDPV2 currently circulating in Chad, which have also been detected in Cameroon. In addition to the case in Borno, cVDPV2 linked to this transmission chain had previously been isolated from an environmental sample in Kano in March, indicating circulation in Nigeria.

Horn of Africa
:: Eight new WPV1 cases were reported in the past week (seven from Somalia and one from Kenya), bringing the total number of WPV1 cases in the region to 81 (72 from Somalia and nine from Kenya). The most recent case in the region had onset of paralysis on 3 July (from Kenya).

:: One of the newly-reported cases from Somaliland, in the north, the first in that area associated with this outbreak and close to the border with Ethiopia. Additionally, some of the newly-reported cases are from inaccessible areas of south-central Somalia.

:: In Somalia, NIDs are currently ongoing (21-25 July), targeting children under the age of five years. Specific radio messages had been developed with the involvement of the Ministry of Religious Affairs, as this latest campaign is being implemented during Ramadan.

:: The next SIAs in Kenya are planned for 27-30 July, targeting host communities around the Dadaab camps.

:: Campaigns across the Horn of Africa, including in Ethiopia and Yemen, will continue throughout August.

WHO: Global policy report on the prevention and control of viral hepatitis

Global policy report on the prevention and control of viral hepatitis
World Health Organization
Number of pages: 220
Publication date: July 2013
Languages: English
ISBN: 978 92 4 156463 2

The periodic evaluation of implementation of the WHO strategy requires an initial baseline survey of all Member States. In mid-2012, WHO, in collaboration with the World Hepatitis Alliance, conducted such a survey, asking Member States to provide information relating to the four axes of the WHO strategy. In particular, Member States were asked whether key prevention and control activities are being conducted. This report presents the results.

The first chapter provides an introduction to viral hepatitis and to the global response to this group of diseases. The second chapter provides a global overview of the survey findings. Chapters three through eight present findings from the six WHO regions, including summaries of data from all responding countries. Additional survey data, study methodology information and the survey instrument can be found in Annexes A–E.

pH1N1 – a comparative analysis of public health responses in Ontario to the influenza outbreak, public health and primary care: lessons learned and policy suggestions

BMC Public Health
(Accessed 27 July 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article  
pH1N1 – a comparative analysis of public health responses in Ontario to the influenza outbreak, public health and primary care: lessons learned and policy suggestions
Paul Masotti, Michael E Green, Richard Birtwhistle, Ian Gemmill, Kieran Moore, Kathleen O¿Connor, Adrienne Hansen-Taugher, Ralph Shaw BMC Public Health 2013, 13:687 (27 July 20 Abstract (provisional)

Background
Ontario’s 36 Public Health Units (PHUs) were responsible for implementing the H1N1 Pandemic Influenza Plans (PIPs) to address the first pandemic influenza virus in over 40 years. It was the first under conditions which permitted mass immunization. This is therefore the first opportunity to learn and document what worked well, and did not work well, in Ontario’s response to pH1N1, and to make recommendations based on experience.

Methods
Our objectives were to: describe the PIP models, obtain perceptions on outcomes, lessons learned and to solicit policy suggestions for improvement. We conducted a 3-phase comparative analysis study comprised of semi-structured key informant interviews with local Medical Officers of Health (n = 29 of 36), and Primary Care Physicians (n = 20) and in Phase 3 with provincial Chief-Medical Officers of Health (n = 6) and a provincial Medical Organization. Phase 2 data came from a Pan-Ontario symposium (n = 44) comprised leaders representing: Public Health, Primary Care, Provincial and Federal Government.

Results
PIPs varied resulting in diverse experiences and lessons learned. This was in part due to different PHU characteristics that included: degree of planning, PHU and Primary Care capacity, population, geographic and relationships with Primary Care. Main lessons learned were: 1) Planning should be more comprehensive and operationalized at all levels. 2) Improve national and provincial communication strategies and eliminate contradictory messages from different sources. 3) An integrated community-wide response may be the best approach to decrease the impact of a pandemic. 4) The best Mass Immunization models can be quickly implemented and have high immunization rates. They should be flexible and allow for incremental responses that are based upon: i) pandemic severity, ii) local health system, population and geographic characteristics, iii) immunization objectives, and iv) vaccine supply.

Conclusion
“We were very lucky that pH1N1 was not more severe.” Consensus existed for more detailed planning and the inclusion of multiple health system and community stakeholders. PIPs should be flexible, allow for incremental responses and have important decisions (E.g., under which conditions Public Health, Primary Care, Pharmacists or others act as vaccine delivery agents.) made prior to a crisis.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

A cross sectional survey of attitudes, awareness and uptake of the parental pertussis booster vaccine as part of a cocooning strategy, Victoria, Australia

BMC Public Health
(Accessed 27 July 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article  
A cross sectional survey of attitudes, awareness and uptake of the parental pertussis booster vaccine as part of a cocooning strategy, Victoria, Australia
Ellen J Donnan, James E Fielding, Stacey L Rowe, Lucinda J Franklin, Hassan Vally BMC Public Health 2013, 13:676 (23 July 2013)

Abstract (provisional)
Background
The Victorian Government Department of Health funded a diphtheria, tetanus and acellular pertussis vaccine for parents of infants from June 2009 to June 2012 as part of a cocooning strategy for the control of pertussis. The aim of this study was to assess parents’ attitudes and awareness of the vaccination program, and to estimate vaccine uptake.

Methods
A cross-sectional survey of 253 families with a child born in the first quarter of 2010 residing within five metropolitan and four rural local government areas in Victoria was conducted. Univariate analyses were performed to describe the relationship between demographic variables, knowledge and awareness of the disease, the vaccine program and vaccine uptake. Multivariate analyses examining predictors for awareness of the vaccine program and for the uptake of vaccination were also conducted.

Results
One hundred and five families were surveyed (response rate 43%). Of these, 93% indicated that they had heard of ‘pertussis’ or ‘whooping cough’ and 75% of mothers and 69% of fathers were aware the pertussis vaccine was available and funded for new parents. Overall, 70% of mothers and 53% of fathers were vaccinated following their child’s birth, with metropolitan fathers less likely to be vaccinated as rural fathers (RR = 0.6, p = 0.002). Being a younger mother (p = 0.02) or father (p = 0.047), and being an Australian-born father (RR = 1.9, p = 0.03) were found to predict uptake of the vaccine in parents.

Conclusion
Parents indicated a reasonable level of knowledge of pertussis and a willingness to be vaccinated to protect their child. However, vaccine uptake estimates indicated further opportunity for program improvement. Future cocooning strategies would benefit from specifically targeting fathers and metropolitan maternity hospitals to increase vaccine uptake. Wider promotion of the availability of vaccine providers may increase uptake to maximise the success of cocooning programs. Further investigation of the effectiveness of the cocooning strategy in decreasing infant morbidity and mortality is required.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

Determinants of government HIV/AIDS financing: A 10-year trend analysis from 125 low- and middle-income countries

BMC Public Health
(Accessed 27 July 2013)
http://www.biomedcentral.com/bmcpublichealth/content

Research article  
Determinants of government HIV/AIDS financing: A 10-year trend analysis from 125 low- and middle-income countries
Carlos Ávila, Dejan Loncar, Peter Amico, Paul De Lay BMC Public Health 2013, 13:673 (19 July 2013)

Abstract (provisional)
Background
Trends and predictors of domestic spending from public sources provide national authorities and international donors with a better understanding of the HIV financing architecture, the fulfillment of governments’ commitments and potential for long-term sustainability.

Methods
We analyzed government financing of HIV using evidence from country reports on domestic spending. Panel data from 2000 to 2010 included information from 647 country-years amongst 125 countries. A random-effects model was used to analyze ten year trends and identify independent predictors of public HIV spending.

Results
Low- and middle-income countries spent US$ 2.1 billion from government sources in 2000, growing to US$ 6.6 billion in 2010, a three-fold increase. Per capita spending in 2010 ranged from 5 cents in low-level HIV epidemics in the Middle East to US$ 32 in upper-middle income countries with generalized HIV epidemics in Southern Africa. The analysis found that GDP per capita and HIV prevalence are positively associated with increasing levels of HIV-spending from public sources; a 10 percent increase in HIV prevalence is associated with a 2.5 percent increase in domestic funding for HIV. Additionally, a 10 percent increase in GDP per capita is associated with an 11.49 percent increase in public spending for HIV and these associations were highly significant at the .001 percent level.

Conclusion
Domestic resources in low- and middle-income countries showed a threefold increase between 2000 and 2010 and currently support 50 percent of the global response with 41 percent coming from sub-Saharan Africa. Domestic spending in LMICs was associated with increased economic growth and an increased burden of HIV. Sustained increases in funding for HIV from public sources were observed in all regions and emphasize the increasing importance of government financing.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.