New medicines are our lifeblood at AstraZeneca—both small molecule and biological products that address the unanswered needs challenging patients, families, and caregivers.
Product development in the pharmaceutical environment is a long and complex process—taking upwards of 10 years, consuming many resources, and ultimately requiring safety and efficacy in preclinical and clinical settings. Early research on thousands of compounds is winnowed down until just a handful of products are developed over time. Research is terminated wherever compounds aren’t sufficiently effective in treating the target disease or they present unacceptable side effects.
Our clinical trials are guided by global standards and by our concern for the lives of the patients who put their trust in us. A clinical trial is conducted only after we’ve gathered satisfactory safety and efficacy information from preclinical research and have filed the required applications with our regulators. We’re not only working to protect trial participants from unnecessary risks. We’re also making certain that those who participate in our trials fully understand what clinical trial participation means—before they give their consent—and that their participation is guarded by strict privacy policies.
Running the trials
AstraZeneca is committed to making information about our clinical trial activities publicly available. We publish information on the registration and results of all new and ongoing AstraZeneca-sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development, and drugs whose further development has been discontinued. We post results, whether they are favorable or unfavorable to AstraZeneca. These disclosure requirements are set out in our global Bioethics Policy and compliance is mandatory across the company.
Because we operate in an ever-changing environment, we continue to monitor closely developments and advances in this area, so that AstraZeneca remains at the forefront of best practice in clinical trial transparency.
Since June 2010, trials are registered on the U.S. National Library of Medicine’s website prior to the first patient being enrolled in a trial and to other websites within timelines as required by law. We also post basic information on our own dedicated website.
Results of trials with already-marketed medicines are posted within one year of completion. Results of trials with medicines in development are posted within 30 days of first regulatory approval for the new medicine. When a medicine in development has been discontinued, results are published within one year of the public announcement of the decision, unless analysis and interpretation of the data are not sufficiently complete, in which case we post a brief explanation for the delay and the anticipated date when the results will be posted. For marketed medicines and recently approved medicines, where we consider there to be good cause to delay posting of results, we will seek necessary approval according to applicable law. Where approved, we post a brief explanation for the delay and the anticipated date when the results will be posted.
Our commitment is to deliver ethical sales and marketing practices that meet or exceed the standards set by external regulations and codes of practice, all designed to protect and advance patient health. AstraZeneca U.S. codes of practice are in line with our global code of conduct and policies.
The AstraZeneca Promotional Regulatory Affairs (PRA) team assists with interpreting and applying FDA regulations pertaining to prescription drug advertising and promotions. This team of individuals with regulatory, scientific, and legal backgrounds focuses specifically on approving promotional or scientific materials for release, to ensure that these meet all applicable internal and external code requirements. The PRA team provides unbiased advice and support to the Sales and Marketing, Medical, and R&D organizations to support the planning and development of promotional and non-promotional materials and activities intended for, or involving, health care professionals, health care professional organizations, government officials, community organizations, or the general public.
AstraZeneca works with physicians to educate other health care professionals on the use, safety, and benefits of our medicines. Patients ultimately benefit when physicians are well-informed and knowledgeable about our medicines, treatment options, and standards of care. Before physicians can speak on our behalf, they must participate in extensive training on our medicines, our policies, and the laws and regulations that apply to company-sponsored presentations.
AstraZeneca believes it is appropriate and ethical to compensate health care professionals for the work they do on our behalf. Physicians who speak about our products are compensated at a fair market value based on the physician’s qualifications and the amount of time required to provide the service. We have policies in place to ensure that our payments to physicians do not create conflicts of interest or otherwise influence the decisions these physicians make in treating patients. In addition, we are working to ensure full transparency surrounding payments to physicians, and in other areas where patients and other interested stakeholders have voiced concern over manufacturer influence.
For example, AstraZeneca now posts the following information in the transparency section of our site:
- Payments and other transfers of value provided to US-based physicians
- Payments to US-based medical and research institutions
- Contributions to nonprofit organizations
- Details of new and ongoing clinical trials sponsored by AstraZeneca
- Biannual reports of our independent medical education grants to educational provider organizations
- Political contributions
- Post-marketing study commitments
AstraZeneca is committed to reporting product safety information and adverse events promptly. Information on possible side effects is conveyed to AstraZeneca from many different sources, including doctors, pharmacists, regulatory authorities, and patients. We also identify potential safety issues through our clinical trials, by reviewing reports in medical journals and scientific literature, and by monitoring health care databases maintained by doctors, health insurance companies, and regulators. Additionally, our global Code of Conduct requires AstraZeneca employees to report possible adverse effects related to our medicines.
After launch, we continually monitor use of our medicines for any side effects not identified during the development process, ensuring that accurate and up-to-date information concerning the safety profile of our drugs is provided to regulators, health care professionals, and, where appropriate, patients.
Clinical trials, although extensive, cannot replicate the complete range of patient circumstances and rare side effects that can often be identified only after a medicine has been launched and used by far more patients and over longer periods of time.
Our global patient safety database is designed to gather this information centrally—both for our use and for regulators. Our system includes mechanisms for highlighting events that require immediate attention.
If the information we receive suggests that a medicine’s benefit/risk profile has changed, actions taken (in consultation with regulatory agencies) can include carrying out further clinical trials, modifying prescribing information, and communicating with health care professionals and others who need to know of the change. In certain situations, it may be appropriate to stop a clinical trial or withdraw a product from the market.