Pharmaceutical companies spend millions each year purchasing commercial marketed products for use in clinical studies. With a decreasing supply, increasing demand, and cost of these “Comparators,” there is opportunity for a counterfeit issue to arise.
There are no efficient mechanisms to acquire clinical trial comparator drugs and co-therapy, as supply chain intermediaries frequently decrease security, introduce delays and cannot provide access to key drug documentation.
The purpose of the Comparator Network Initiative is to establish reliable, rapid sourcing of quality products for use in clinical trials through a Comparator Network, ultimately enabling accelerated trial timelines and enhanced patient safety.
The Comparator Network has helped enhance patient safety due to known source of materials and comparator drug documentation. It has limited the chance for counterfeits to enter the investigational supply chain and allows for the continuity of drug supply for products used in studies.
The success of the Comparator Network lays the foundation for the sharing of materials beyond commercial product such as bulk drug product, and blinded active and placebo. These newly expanded exchanges have potential to reduce clinical trial costs and complexity, reduce the risk of unblinding and improve patient safety by ensuring that comparators are used in their intended presentations.
Access to the Comparator Network is provided for TransCelerate Member Companies only. To inquire about membership, please contact us through this email address: firstname.lastname@example.org
Common Protocol Template
The Common Protocol Template Initiative is working with industry stakeholders and regulators to create a model clinical trial protocol template containing a common structure and model language to improve accuracy in data recordation and speed study start up.
Placebo and Standard of Care Data Sharing
The Placebo and Standard of Care (PSoC) Initiative was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.