The Therapeutic Development Network (TDN) is a clinical trial platform through which leading Alpha-1 specialists, researchers, and biopharma partners work collaboratively to improve trial recruitment and design advanced patient-focused drug development programs.
The TDN leverages the Alpha-1 Research Registry and our extensive network of Clinical Research Centers to help industry partners with everything from trial design and site selection to trial recruitment.
For more information, please contact Randel Plant at rplant@alpha1.org or 1-877-228-7321, ext. 306
| Question | Alpha-1 Research Registry | Therapeutic Development Network (TDN) |
| Who can participate? | – Anyone diagnosed with Alpha-1, regardless of age | – Anyone with Alpha-1 with severe deficiency, with or without lung or liver disease – Alpha-1 carriers who are relatives of Alphas enrolled in the TDN – Alpha-1 carriers with lung or liver disease |
| What type of data is collected? | – Self-reported information regarding various aspects of your clinical history – A few medical records | – Medical record information specific to known/planned clinical trial inclusion criteria |
| Who enters the data into the database? | – Alphas answer questions regularly for as long as they participate in the Research Registry & at their convenience – Alpha-1 Research Registry team enters medical records when provided by the participant | – The TDN staff reviews the participant’s medical records and enters data into the TDN database |
| How much data is collected? | – Approximately 1,200 data points collected for each patient – Small number of medical records | – Approximately 150 data points upon enrollment – Approximately 75 data points every 3 months thereafter |
| Who has access to the data? | – Alpha-1 Research Registry staff – Third-party researchers are granted access to de-identified data to support epidemiologic studies upon approval post-application process | – TDN staff – TDN center staff; only the information assigned to their center to identify potentially eligible clinical trial participants |
| How is the data used? | – Alpha-1 Research Registry team uses the information to identify knowledge gaps and educate Alphas on key clinical issues – Epidemiologists use the data to understand Alpha-1 | – TDN team uses de-identified information to help researchers design clinical trials – TDN center staff use identifiable information to identify Alphas that may qualify for a clinical trial |
