Accelerating Translational Research through Community Engagement and Advocacy Leadership
Genetic Alliance and Sage Bionetworks are accelerating drug development through community engagement and advocacy leadership in translational research. Our goal is to revolutionize the translational research paradigm through consumer activism. We do this by providing consumers and advocacy leaders with the tools and information needed to empower informed participation in research.
What Is Translational Research and Why Is It Important?
Translational research is the process by which the fundamental biological insights generated through basic research are transformed into products that improve human health. Translational research promises to reduce the burden disease places on affected individuals, their caregivers, and communities. The products of translational research will improve all aspects of healthcare, including earlier diagnosis through genetic testing, better management of disease with superior biomarkers, and improved treatment options via novel, more individualized therapies. Translational research is essential if we as a society are to realize the promise of a healthcare system that is affordable, sustainable, and accessible to all.
Empowering Participation and Fostering Collaboration in Translational Research
Public participation and widespread data sharing are critical for the future of translational research. The public is the chief stakeholder in biomedical research, assuming the majority of the risks involved in clinical research and realizing the greatest benefit from new therapeutic discovery. However, beyond donating clinical samples and data, few mechanisms exist to engage research participants in the research process. Data, after it is generated, resides with the clinical trial sponsor. Although the technology exists to enable broad data sharing, clinical data is rarely reused. Data sharing, when it does occur, is governed by ethics and institutional review boards that cannot possibly account for the preferences of individual research participants.
We believe that research participants should be allowed to manage when and how their clinical data is used. The technological platforms need to allow research participants to govern the use of their data exist. Genetic Alliance is committed to educating the public on the importance of data sharing and creating meaningful mechanisms for engaging participants in research. And although collaboration is not the norm in biomedical research, Genetic Alliance is partnering with other organizations committed to greater openness to pave the way for greater data sharing in research. To learn more about these topics and how Genetic Alliance is empowering public participation and fostering collaboration in translational research, click on the links below.
- Power to the People: Participant Ownership of Clinical Trial Data
- Accelerate medical breakthroughs by ending disease earmarks
- Electronic Consent Channels:
Preserving Patient Privacy Without Handcuffing Researchers
- Biomedical technology and the clinic of the future [PDF]
- Personalized investigation [PDF]
- How the Social Web Supports Patient Experimentation with a New Therapy [PDF]
- Sharing Health Data for Better Outcomes on PatientsLikeMe [PDF]
On April 15-16, 2011 SAGE Bionetworks, a nonprofit organization committed to creating an open access integrative bionetwork, hosted their annual Congress to reflect on the progress of the past year and discuss the changes that will need to be made in the coming year. Genetic Alliance President & CEO Sharon Terry helped lead the working group on public engagement. View footage of this year’s Sage Congress.
The Clinical Trial Comparator Arm Partnership (CTCAP) is a new public-private partnership lead by Sage Bionetworks and Genetic Alliance. The goal of this partnership is to compile an open repository of datasets from the comparator arm of clinical trials. Learn more about this partnership.
Genetic Alliance is also a founding member of the Archipelago To Proof of Concept in Medicine (ARCH2POCM) public-private partnership pioneered by Sage Bionetworks. ARCH2POCM is a public-private partnership that seeks to organize an open access scientific and clinical network for taking high risk/high reward disease targets through to clinical validation of mechanism. Learn more about this partnership.
Registries and Biobanking
In addition to empower research participants, Genetic Alliance has also developed tools to help advocacy groups take on a more active role in translational research. In 2003, we launched the Genetic Alliance Registry and BioBank (GARB) to provide disease advocacy groups with the platform and technology needed to build and steward their own registries and biobanks. GARB was founded on the principle that advocacy-run registries and biobanks would initiate, accelerate, and transform translational research. Click here to learn more about GARB.
Enthusiasm for participation in research and data sharing is often tempered by the concern that our clinical information will leave us vulnerable to discrimination. While it is important to take care that data from participants is not abused or misused, widespread data sharing is undoubtedly needed to advance translational medicine, so a balance must be struck. The Genetic Information Nondiscrimination Act (GINA) of 2008, signed into law on May 21, 2008, establishes the basic legal protections to prevent health insurers from denying coverage or adjusting premiums based on an individual’s predisposition to a genetic condition and prohibits employers from discriminating on the basis of predictive genetic information. To learn more on this topic and existing protections against discrimination, please visit Ginahelp.org.
Learn More About How Advocacy Organizations Are Impacting Research
Disease advocacy organizations play an enormously important role in translational research. Although disease advocacy groups traditional focused on providing services and public education, advocacy groups are taking on a leadership role in directing research with increasing frequency. What was once novel is now the norm. Advocacy contributions to research include running registries and biobanks, generating research hypotheses, offering advise on study design, reviewing grants, and directly funding research. To learn more about how disease advocacy groups are accelerating translational research, click on the links below.