Conduct of Clinical Trials & Postmarketing Commitments
Our scientists are leveraging the latest technologies and scientific advances to discover and develop new medicines.
Clinical Research is a Key Component of Developing New Medicines
A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Sometimes these studies include healthy volunteers but most of the studies are conducted in patients with the diseases we are studying.
Local authorities, such as the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the U.S. Food and Drug Administration (FDA), as well as those in many other countries, use the data gathered in these trials to determine whether or not to approve the drug for use in their countries. To ensure these studies are conducted to the highest standards of protection for individuals who participate in the studies, AbbVie strictly follows important rules governing clinical research. These include the World Medical Association’s (WMA) Declaration of Helsinki, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local rules and regulatory requirements.
We are Committed to Good Clinical Practice
Throughout the clinical trials process, patients remain our highest priority. Good Clinical Practice (GCP) is a global ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with this standard provides public assurance that the rights, safety and well -being of trial subjects are protected, consistent with global ethical standards and regulatory requirements. Compliance also assures the credibility of the clinical data. AbbVie is committed to ensuring Good Clinical Practice is strictly adhered to within all AbbVie-sponsored clinical trials.
The clinical development process is divided into phases that help us learn important information in a step wise fashion. Depending on the drug and disease being studied, the process might begin with a single dose in healthy volunteers. For other disease states such as cancer, the studies may start with patients and allow dosing for as long as the patient is getting benefit from the drug. There is not a single method that can be used for all drugs and diseases. However, there are some general steps that are important for the development of all drugs depending on the trial participants and the aspects of the drug being assessed. Clinical trials can take place prior to the approval of a drug (premarket) and after the approval of a drug (postmarket).
- Phase 1 studies are the first time an investigational drug is given to humans. These studies help determine how often a drug should be given and if there are important side effects that doctors and patients need to be aware of.
- Phase 2 studies have the primary objective of exploring the therapeutic effect and to further evaluate safety of a drug in patients with the disease or condition intended for treatment.
- Phase 3 studies are conducted in larger groups of patients and are conducted to confirm the safety and efficacy of a drug in the treating the intended disease. Because Phase 3 studies are larger, they allow investigators to find and understand less common side effects of the drug. This is important information for doctors and patients to know before use in the wider general population. Phase 3b studies are either studies conducted while a drug is under review by a regulatory authority or are studies conducted in patients that do not fall within the proposed or approved drug label.
- Phase 4 postmarketing studies are conducted after a drug is approved to gain additional information, including the drug’s effects across various populations and side effects associated with long-term use in the drug’s approved indication.
Partnering with Patients in Clinical Development
When developing new medicines, we partner with patient groups and patient advisors. This enables us to understand the patient experience and their needs. This understanding informs the clinical trials that we conduct and ensures that we’re developing new medicines to make a remarkable impact for patients. Find more information about AbbVie clinical trials here.
Partnering with Clinical Trial Investigators
AbbVie partners with leading scientific and medical professionals around the world to conduct clinical trials. AbbVie establishes collaborative partnerships with our clinical trial sites and values their significant contributions to our scientific innovation.
To participate as a clinical trial investigator/investigative site on an AbbVie trial, register your interest here.
Following approval of a drug or biologic product, the US Food and Drug Administration (FDA) or other regulatory agencies may request and/or require the sponsoring company to conduct further studies that are designed to gather additional information about the product’s safety, effectiveness and/or optimal use. These Postmarketing Commitment (PMC) studies build upon the data that was submitted for approval.
To view our Postmarketing Commitments in the United States (and those of our prior sponsor, Abbott Laboratories), see our PMC Summary Table.
The Postmarketing Commitment Summary Table includes our active PMCs and provides the following information, organized alphabetically by product name:
- Name of Product New Drug Application (NDA)/ Biologics license application (BLA) Number
- Description of Commitment
- Date Commitment Given
- Projected Completion Date
- Commitment Status
Please note that the status and/or number of our PMCs shown on the FDA website may differ from the information displayed on our PMC Summary Table due to the timing of content review and website updates. The status categories used in the PMC Summary Table are consistent with categories used by the FDA.
Information about our Postmarketing Commitments will be updated twice a year to reflect new commitments as well as the progress we have made in fulfilling our existing PMCs. Once the FDA determines a PMC is fulfilled or should not be completed, or if we terminate a study before completion date, those PMCs will be removed from our PMC Summary Table.
The Postmarketing Commitments listed in the PMC Summary Table include nonclinical (nonhuman), clinical (medical) and epidemiological studies that we have agreed to conduct to gather additional information about the safe and effective use of our approved products. This website does not contain technical chemistry, manufacturing and controls PMCs or PMCs for products for which our company does not hold the US regulatory approval.