Monday, 23 November 2009

Abbott Laboratory research in HIV, ANTIBIOTIC,General anaesthestic, NSAID

Abbott One of the Best Places to Work for Scientists
Abbott has again been named to The Scientist magazine's "Best Places to Work in Industry," this year ranking sixth among companies with more than 5,000 employees.
Clinical Trial Registrations and Results Disclosures
Abbott understands that a critical component of medical product development is the conduct of clinical trials (also referred to as clinical studies) in humans to evaluate the safety and effectiveness of medical products for the diagnosis, treatment, and prevention of disease.

Abbott is committed to being transparent about the clinical trials we sponsor. We recognize that there are important public health benefits to making clinical trial information available to healthcare providers, patients, and the public. Therefore, Abbott has adopted these principles regarding the disclosure of information relating to the clinical studies that we sponsor.

Our registrations and results disclosures will adhere to the following laws:

Public Law 110-85, Section 801, Clinical Trial Databases, of the Food and Drug Administration Amendments Act of 2007 (FDAAA), and
22 M.R.S.A. § 2700-A, State of Maine, An Act Regarding Advertising by Drug Manufacturers and Disclosure of Clinical Trials.
In addition, Abbott respects the influence of the following organizations regarding registrations and results disclosures. However, where policies of the following organizations conflict with the above laws, Abbott will defer to the laws.

WHO Technical Consultation on Clinical Trial Registration Standards (April 2005),
Joint Position Statement on the Disclosure of Pharmaceutical Clinical Trial Information (Nov 26, 2008) , and
International Council of Medical Journal Editors (ICMJE), Uniform Requirements for Manuscripts.
Clinical Trial Registrations
Abbott will register all applicable clinical studies, regardless of outcome, in a publicly accessible clinical trials registry (www.ClinicalTrials.gov). For drugs, this means that we will register all phase 2-4 interventional trials. For medical devices, this means we will register prospective interventional clinical studies of health outcomes, except feasibility studies, and FDA-designated pediatric postmarketing surveillance studies. Registration information will be provided according to the laws and policies mentioned above.

Clinical Trial Results Disclosures
Abbott will disclose the results of all applicable clinical trials, regardless of outcome, in a publicly accessible clinical trials results database (www.ClinicalTrials.gov). For pharmaceuticals, this means that we will report results for all phase 2-4 interventional trials for our approved products. Consistent with the Joint Position Statement on the Disclosure of Pharmaceutical Clinical Trial Information, we will also report the results of any exploratory pharmaceutical clinical trials if we deem the findings to have significant medical importance (e.g. an important safety finding). For medical devices, this means we will report results for prospective interventional clinical studies of health outcomes, except for feasibility studies. In addition, we will post results for FDA-designated pediatric post-marketing surveillance studies of medical devices.

Global Initiatives
In an evolving international regulatory environment around clinical trial disclosure, Abbott engages with the aforementioned stakeholders to stay abreast of new requirements for registrations and results disclosures. We continue to work with industry partners, trade associations, regulators, international health organizations, academics and patient groups to develop a global framework for registrations and results disclosures. Abbott also actively participates in trade association activities aimed at increasing clinical trial transparency.

As a member of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Abbott supports the IFPMA Portal. This portal helps users access information about ongoing pharmaceutical clinical trials and the outcomes of completed trials through custom searches. Since the Portal was launched in September 2005, the IFPMA has worked to expand its functionality and ease-of-use. Improvements subsequently added to the Portal include four additional language interfaces, plus features such as search by trial location and e-mail alert.

The Portal is provided by IFPMA on behalf of its member companies and associations. The portal offers a single entry point for the public to access comprehensive information regarding pharmaceutical clinical trials and results of completed triALS. For more information visit http://www.abbott.com/global/url/content/en_US/20.10:10/product/Products_A-Z_List.

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