Clinical Trials

Responsible Approach

The pharmaceutical and medical products industries are among the most heavily regulated industries in the world, particularly with regard to the development of new medicines and conduct of clinical trials. Abbott abides by national regulations and international standards as well as our own internal policies to ensure the highest standards of ethics, product quality, and patient safety.

Delivering a medicine from the laboratory to the patient involves discovery and development. In discovery, researchers identify and target molecules with potential for development, then conduct preclinical research on these molecules. Once a compound is determined to be a viable candidate, development gets underway, with clinical trials to evaluate its safety, efficacy, optimal dosing and other key findings.

There are three distinct phases of clinical trials. Phase I is conducted on a relatively small number of healthy volunteers to determine whether the drug candidate works in humans as it did in animals and computer models, as well as to obtain information on safety and dosage. Phase II involves a larger number of patients and continues to evaluate the safety and efficacy of the drug, often experimenting with different amounts and dosing frequencies. Phase III is the final, pivotal phase of clinical trials required by government regulators before making the drug widely available through prescription. Regulators have highly specific guidelines for clinical trials, which typically involve hundreds or thousands of patients.

Clinical trials on human subjects are a critical step in bringing safe, effective and correctly dosed medicines to patients. Safety of study subjects is always Abbott’s highest priority, and we take a number of steps to assure that our high standards of quality, safety and transparency are upheld at all stages and in all countries around the world where we conduct trials. We have standard operating procedures in place for all employees involved in conducting trials, and they receive dedicated training on these procedures.

Informed consent is crucial for both the safety of participants and the success of trials. Healthy volunteers and patients who are interested in participating in our clinical studies engage in a full discussion of the process with clinical professionals and undergo an appropriate medical screening before entering the trial. Informed consent documentation is drafted in language that’s easy for patients to understand and is also translated into different languages if required, to make sure trial subjects have the information they need to make an educated decision on whether to take part in the trial.

Trials are subject to internal as well as independent external scrutiny at every stage. Abbott’s internal ethics committees review protocols, and data-monitoring committees make sure data is fairly presented and appropriately shared. Additionally, we work with independent review boards to make sure our studies meet local, national or international guidelines.

Product Safety

Patient safety is paramount. We have a number of processes in place to make sure that we meet the highest safety and quality standards during the design and development, manufacture, delivery and labeling of our products. In 2007, we made a number of enhancements to our quality and regulatory systems, including:

• Working to harmonize quality and compliance of all product requirements on a worldwide basis. This is a significant challenge in a global market where each individual country also has its own regulations
• Simplifying our quality policies company-wide so they are easier for employees to understand and apply. These policies are clearly stated global requirements.
• Employing a “quality by design” approach, focusing on improving manufacturing efficiencies and consistent delivery of product that fulfills our customers needs.

Responsible Marketing Practices

Abbott is a leading manufacturer of infant formulas. We agree with medical and health organizations throughout the world that breastfeeding is the best form of infant nutrition and should be the first choice for babies. When an alternative to breastfeeding is necessary or chosen, we offer high-quality infant formulas and nutritional products. We comply with all relevant laws, regulations and promotional standards around the world. This includes adhering to principles of the International Code of Marketing of Breastmilk Substitutes where it has been implemented by governments.

Infant Nutrition

Working with Research Partners

Much of our clinical trial work around the world is conducted in partnership with contract research organizations (CROs). It is critical that all CROs commissioned by Abbott meet our high standards of clinical trial conduct, particularly on subject safety. There are multiple procedures in place to ensure that CROs understand and conform to all Abbott’s standards, and we perform regular reviews of all CRO conduct. Abbott employees who work with CROs receive training and consult company policies in this area, including on the selection and monitoring of CROs.

Trials in Developing Countries

Increasingly, clinical trials are being conducted in developing and emerging regions. In these countries, as everywhere in the world, we abide by the Helsinki Declaration, World Health Organization Good Clinical Trials Standards and Abbott policies to ensure the highest standard of ethics in conduct of clinical trials.

Clinical Trials Transparency

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. Abbott is committed to registering all applicable clinical studies regardless of outcome on the publicly accessible clinical trial registry www.ClinicalTrials.gov. To date, Abbott has registered over 150 trials initiated under our sponsorship and additionally independent investigators have registered over 100 trials designating Abbott as a collaborator.

Clinical Trial Registration

No later than 21 days after the initiation of patient enrollment, Abbott lists all studies in serious and life-threatening diseases that investigate primary or secondary efficacy endpoints, in compliance with Section 113 of the 1997 Food and Drug Administration Modernization Act.

These registrations will adhere to the compliance specified by the following laws and organization standards: Section 113 of the FDA Modernization Act of 1997 (FDAMA), 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, the following registration information will be provided: unique trial number, trial registration date, secondary identifiers, sponsors, collaborators, brief title, official title, human subjects review, brief summary, study phase, study type, recruitment status, study start date, study design, outcome measures, intervention type and name, condition, inclusion and exclusion criteria, target sample size, central contact and study officials. For some studies, additional fields may also be disclosed.

Following these standards, Abbott registers clinical trials active on, or initiated after, July 1, 2005.

Clinical Trial Results Disclosure

Abbott discloses the results of all clinical trials regardless of outcome, other than exploratory studies, in a publicly accessible clinical trials results database www.ClinicalStudyResults.org, on any pharmaceutical product that is approved for marketing and is sold in at least one country.

Abbott also discloses trial results from exploratory studies if they are deemed to be of significant medical importance. Abbott posts 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. Results of efficacy and safety registration trials active on or after October 2002 will be disclosed once the product is approved for marketing in at least one country.

Global Initiatives

In a constantly changing regulatory environment, we seek to engage with all stakeholders to ensure that we are not only staying abreast of regulation but also proactively moving the debate forward. We continue to work with industry partners, trade associations, the U.S. Congress, 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. In addition to English, the IFPMA Portal allows users to search in French, Spanish, German and Japanese languages, making it a unique and valuable international tool.

The Portal allows access to, and search capabilities for, two broad types of information:

1) Listings (registries) of ongoing clinical trials throughout the world, providing access to basic information, such as brief title, description in lay terms, trial phase, trial type (e.g. interventional), trial status, trial purpose (treatment / diagnosis / prevention), intervention type (e.g. drug / vaccine), condition or disease, key eligibility criteria (including gender and age), location of trial and contact information; and

2) Links to the results of completed clinical trials, which are made available in a standard, non-promotional, summary format by various on-line databases.

This search 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).

Publishing Clinical Trial Results in Journals

One way we present a full picture of clinical trial results to stakeholders is through published manuscripts in peer-reviewed journals. Within the industry, there is ever-increasing scrutiny of scientific publication integrity, and questions have recently arisen about improper influence on journal articles by pharmaceutical companies. A draft Abbott publication policy, expected to be fully approved in 2008, provides guidance for all employees on issues such as criteria for authorship, acknowledging medical writers and other contributors, access to data, and disclosing conflict of interest and clinical trial sponsorship.

The goal for this policy is to establish a corporate standard to ensure that Abbott develops publications in a consistent and transparent manner, applying the highest ethical standards.