As most pharmaceutical professionals know, environmental regulations can have a significant impact on the design and conduct of drug development studies. Laws regulating cigarette smoking in research and clinical settings are no exception. While these laws vary from state to state, and even study to study, they are an important consideration when planning drug development studies. The state of Washington is an exemplar.
And so, because of Washington state smoking laws, when TigerTox conducts clinical or preclinical studies with a study device, we have to evaluate whether the device can be allowed for advertisement or internal use at our respective sites, i.e., cigarette smoking is allowed. Our review considers any applicable local smoking laws. If the study device is not allowable under the applicable local smoking laws, our team pulls together a list containing all the sites where cigarette smoking is not permissible during the time of the study, daily smoking hours, and any other local restrictions. We then present our list to our clients to help identify potential alternative sites.
For all preclinical and clinical studies, our project managers also review the proposed study design to ensure compliance with applicable regulations. All of our client communication focuses on maximizing the quality of your data while minimizing the costs and time associated with study conduct. Strategic thinking is promoted from the time a study is conceived, throughout the study, and even after its completion. For clinical studies, this means that our team has a constant pulse on the regulations governing them.
The same is true for preclinical studies – although some of these studies require longer lead times for planning and conduct than a clinical study, being ahead of the regulations helps ensure there are no delays in study start-up or conduct. We work with clients from the beginning of the study and throughout its course to ensure all applicable regulations are met.
In addition to studying regulations and their potential impact on your study, our regulatory team can help identify if any of your study devices are subject to other regulations. Our team monitors any updates to our clients’ regulatory requirements and assesses whether there could be an impact on a study. Because we already know the potential impact of all applicable regulations, our team can help direct smart resource allocation. Finally, our team can aid our clients when advocating for changes to local regulations that are encumbering the conduct of your study.
All studies have to meet the applicable regulations and laws. For clinical studies, our team checks whether a study involves an investigational product that is a drug, biologic, or device and makes sure that the applicable regulations are followed.
For preclinical studies, our regulatory team is also well versed in basic research regulations including the Good Laboratory Practice (GLP) regulations. Broadly, these regulations generally require GLP studies to be conducted at laboratories registered with the FDA. Most commonly, a GLP-compliant lab will conduct the study, but firms like TigerTox can also conduct GLP-compliant studies. Our regulatory team can help assess the best strategy for your study. If necessary, our team can also help you communicate with the FDA and advocate on your behalf.
If you would like to keep up with changes to the applicable regulations or seek clarification on any of the federal or local laws that may apply to your study, my colleague has provided a guide to Washington state smoking laws that an affiliate at one of our sites recommended to us. This guide allows readers not only to understand the applicable laws but also provides further resources as well as a list of several common questions and their answers. It is a good starting point if you want to visit the rapidly changing smoking laws and their implications for health policy, public health behavior, and research regulations.
If you would like to learn more about how smoking laws could impact your next study, or if you are interested in seeing how more broadly applicable laws could impact your research, consider reviewing the aforementioned guide to Washington state smoking laws. It could save you valuable time later down the road.