The Therapeutic Development Network (TDN) is an advanced patient-focused clinical trial platform through which leading Alpha-1 clinicians, researchers, and biopharma partners collaborate to improve trial recruitment and design advanced patient-focused drug development programs.
At its core, the TDN serves a dual mission. First, it aims to quickly identify, and match Alphas interested in clinical trials with suitable opportunities. Second, it partners with the pharmaceutical industry and academic researchers to develop trials that reflect the experiences diagnostic and treatment journey of the Alpha-1 community and to execute these studies efficiently at treating centers with highly qualified staff. This precise, patient-centered approach streamlines recruitment, while ensuring that clinical trials are designed for maximum patient benefit and are conducted at the highest standards of care.
The TDN leverages two of our most impactful programs – the Alpha-1 Research Registry (collection of data describing the natural history of Alpha-1) and our extensive network of Clinical Research Centers. TDN participants are also participants in the Registry and the TDN Center network is a sub-set of Clinical Research Centers.
The TDN and the Alpha-1 Research Registry are vital in driving meaningful research, empowering participants, and moving closer to new treatments and therapeutic solutions for Alpha-1. Participation in the TDN and Registry directly supports the discovery of new therapies and progress towards a cure for Alpha-1. Together, these initiatives are paving the way for breakthroughs in the fight against Alpha-1.
Joining the TDN is a meaningful way to influence valuable research while staying informed about opportunities tailored to your health status and preferences. You are taking an active role in shaping future clinical trials and exploring opportunities to participate in research. When new clinical trials are available, those who may be a good fit will be contacted directly by an enrolling TDN Center and the A1F TDN team. Participation in any clinical trial is entirely optional and requires your consent, ensuring your involvement is always up to you.
Alphas who wish to join the TDN can do so via their care center, if it is part of the TDN Center network, or through our TDN Virtual Center. Participation begins with signing the TDN informed consent form, which allows the collection of targeted medical information and enables future contact for matched clinical trials. Every few months, TDN participants are contacted for updates on their health and to ensure their medical records remain current.
Individuals that wish to participate in the TDN must meet a narrow set of inclusion criteria including participation in the Alpha-1 Research Registry – a critically important program that supports A1F’s mission to build a comprehensive database detailing the natural history of Alpha-1.
| 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, and 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. The 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 and third-party researchers are granted access to de-identified data to support epidemiologic studies upon approval post-application process | TDN staff and TDN Center staff only use 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 |
For more information, please contact Randel Plant at rplant@alpha1.org
