Dear Firends,

This table provides catch-up schedules and minimum intervals between doses for children whose vaccinations have been delayed.

Best regards, 

Attachments
 Catchup4through18.pdf [106 KB] ::

Dear Firends,

This schedule includes recommendations in effect as of December 15, 2009.

Best regards,

Attachments
 7through18.pdf [100 KB] ::

Dear Firends,

This schedule includes recommendations in effect as of December 15, 2009.

Kind regards,

Attachments
 0through6.pdf [139 KB] ::

Dear Friends,

The 2010 recommended childhood and adolescent immunization schedules have been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians.

Please find attachment here.

Best regards,

Attachments
 Immunization.pdf [217 KB] ::

Dear Friends,

The European Medicines Agency (EMEA) first guideline on developing products to treat cystic fibrosis advises drug makers to use forced expiratory volume (FEV) as the primary lung-function endpoint when designing clinical trials for the drugs. A clinically relevant change in FEV should be defined and justified by drug makers, as should the frequency of FEV measurements, according to the final guideline posted on the EMEA’s website last month.

Click here for this guideline

Kind regards,

Dear Friends,

Please find attached US FDA warning letter for the month of December 2009.

Thanks and regards,

Attachments
 December 2009.pdf [25 KB] ::

Dear Friends.

The 2010 version lists about 1,100 laws, regulations, and guidelines on human subject protections from 96 countries. This year’s Compilation includes listings from 5 new countries: Dominica, Guatemala, Honduras, Kyrgyzstan, and Qatar.

Many of the listings include the web address, allowing the reader to link directly to the law, regulation, or guideline of interest.

Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world.

You can reach the version by clicking here or from this link: http://www.hhs.gov/ohrp/international/HSPCompilation.pdf

Kind regards,

Dear Friends, 

Please find attached a commentary on the relation between vegetable intake and islet cell autoimmunity,

Thanks,

Attachments
 Vegetable intake during Pregnancy.pdf [66 KB] ::

Hi,

Please find attached article on proposed treatment algorithm for the use of Dronedarone in the therapy of patients with atrial fibrillation.

Thanks,

Attachments
 dronedarone.pdf [94 KB] ::

Dear All,

Imaging with cardiac ultrasound is a critical element of cardiovascular clinical research. The noninvasive assessment of cardiac structure, function, and hemodynamics using echocardiography can provide essential data on the safety and efficacy of drugs and devices, as well as insight into mechanisms of disease and therapeutic benefit. Echocardiography may also be used to assess enrollment eligibility, provide surrogate endpoints, suggest future research directions, and assist in determining optimal patterns of clinical surveillance. However, the value of this information is highly dependent on the quality of the planning and performance of imaging, the quality of data analysis, and the appropriate incorporation of results into overall trial analysis.  A previous ASE document, "Recommendations for Use of Echocardiography in Clinical Trials," describes the importance of high-quality imaging for research. It recommends methods for some of the common applications of echocardiography, such as determinations of left ventricular ejection fraction and mass, but it does not extensively address the roles and responsibilities of core laboratories or other issues such as personnel, study design, imaging review charters, site management, information technology, and statistical analysis. No other document or guidelines statement exists to fill these gaps. Thus, there is a great need for a clear and universally accepted set of "best practices" in these areas, which form the core of this consensus-driven standards document. 

Click here for this ASE Expert Consensus Statement on Echocardiographic Imaging in Clinical Trials: American Society of Echocardiography Standards for Echocardiography Core Laboratories: Endorsed by the American College of Cardiology Foundation.

Kind regards,

Dear All,

After three years of comment review, the FDA has issued a final guidance on patient-reported outcome (PRO) instruments submitted in applications. Sponsors should define the role a PRO endpoint plays in trials so appropriate statistical methods can be planned and applied, the guidance says. The guidance revises a February 2006 draft, for which the agency received 22 comments.

Click Here for this document.

Kind regards,

NEAC has developed guidelines on conducting intervention studies that aim to contribute to better health outcomes for New Zealanders by further developing best practice in intervention studies.

In an intervention study, an investigator intervenes to prevent, diagnose or treat illness or disease, and also studies the effects of the intervention for its safety and/or benefit. A clinical trial of a new blood pressure medicine is an example of an intervention study.

The evidence that intervention studies provide is a fundamental driver of innovation, patient safety and improved care so healthcare organizations should welcome the conduct of well-designed intervention studies. Intervention studies also have the potential both to benefit and to harm participants, so it is important that they are scientifically and ethically sound.

These Guidelines aim to help investigators to think through and address the ethical issues in their studies. They bring together in one document, and build on, the best current national and international guidance on intervention studies. The Guidelines also aim to assist ethics committees, study sponsors, organisations that host research and others with an interest in intervention studies. They also address New Zealand-specific issues (eg, compensation for injury).

Document availability

Ethical Guidelines for Intervention Studies
If you would like a hard copy of this publication please email neac@moh.govt.nz