Transparency Clinical Trials Registration and Results Disclosures
Clinical Trial Registration 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 health care 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).
- Any other applicable national law.
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
- Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (Updated June 10, 2010) (PDF)
- International Council of Medical Journal Editors (ICMJE), Uniform Requirements for Manuscripts.
- Pharmaceutical Research and Manufacturers of America (PhRMA) Principles on Conduct of Clinical Trials.
Clinical Trial Registrations
Abbott will register all applicable/covered clinical studies, regardless of outcome, in a publicly accessible clinical trials registry (www.ClinicalTrials.gov). For pharmaceuticals, this means that we will register Phase 1 studies conducted in patients and all Phase 2-4 interventional trials subject to FDA regulation at a minimum. For medical devices, this means we will register prospective interventional clinical studies of health outcomes, subject to FDA regulation at a minimum, except feasibility studies, and FDA-designated pediatric post-marketing 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/covered 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 subject to FDA regulation at a minimum. 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, subject to FDA regulation at a minimum, except for feasibility studies. In addition, we will post results for FDA-designated pediatric post-marketing surveillance studies of medical devices.
Prior to the availability of disclosing clinical trial results for pharmaceuticals on (www.clinicaltrials.gov), Abbott disclosed certain clinical trial results on the Clinical Study Results Database created by the Pharmaceutical Research and Manufacturers of America (PhRMA), (www.ClinicalStudyResults.org); however, this database was phased out on 20 December 2011. The clinical trial information previously posted to (www.ClinicalStudyResults.org) through August 2011 is available via this link and is organized via the generic name of the product.
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 and engages in continuing efforts to ensure compliance with global initiatives for clinical trial transparency. 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 Clinical Trials Portal. This portal helps users access information about ongoing pharmaceutical clinical trials and the outcomes of completed trials through custom searches. 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.