Global Citizenship
Innovating for the Future
Clinical Trial Registration & 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.
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.