Clinical Trial Registration & Disclosure

Disclosure of Clinical Trial Information in Clinical Trials Registries and Results Databases

A critical component of drug development is the conduct of clinical trials (also referred to as clinical studies) in humans to evaluate the safety and effectiveness of the drugs being developed by Abbott and of the drugs marketed by Abbott.

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 principles¹ regarding the disclosure of information relating to the clinical studies that we sponsor.

Clinical Trial Registration

Consistent with the requirements of Title VIII, Clinical Trial Databases, of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Abbott will register all applicable clinical studies regardless of outcome in a publicly accessible clinical trial registry (www.ClinicalTrials.gov).

These registrations will adhere to the compliance specified by the following laws and organization standards: Title VIII, Clinical Trial Databases, of the Food and Drug Administration Amendments Act of 2007 (FDAAA), WHO Technical Consultation on Clinical Trial Registration Standards (April 2005), and the Joint Position Statement on the Disclosure of Clinical Trial Information endorsed by PhRMA and IFPMA in 2005.

Consistent with the preceding standards, registration information will be provided in the following categories: unique trial number, trial registration date, secondary identifiers, sponsors, collaborators, brief title, official title, human subjects review, study description, status, study design, arms and interventions, eligibility, and contact and investigator information.

Clinical Trial Results Disclosure

Consistent with FDAAA, Abbott will disclose the results of all applicable clinical trials regardless of outcome, in a publicly accessible clinical trials results database (www.ClinicalStudyResults.org), on any product that is approved for marketing. Abbott also discloses pharmaceutical trial results from exploratory studies if they are deemed to be of significant medical importance.

Abbott posts pharmaceutical trial results within one year after the product is first approved and sold in any country, unless the posting would compromise publication in a peer-reviewed journal or contravene national laws/regulations.

Global Initiatives

In an evolving international regulatory environment, we are engaging with all stakeholders to stay abreast of new regulations. We continue to work with industry partners, trade associations, regulators, international health organizations, academics and patient groups to develop a global framework for registration and results disclosure. We also actively participate in trade association activities aimed at increasing clinical trial transparency.

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Portal helps users access information about ongoing 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 on ongoing clinical trials (registry) and results of completed trials (database).

Legal Disclaimer

This information is not intended nor should it be used to replace the advice of health care professionals. Physicians or other health care professionals making prescribing decisions should always consult the specific labeling information approved for the patient’s country.

1	Joint Position Statement on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases, as originally issued by IFPMA, PhRMA, EFPIA, and JPMA in January 2005 and as revised by same in September 2005.