With the rise in precision medicine, clinical trial protocols and post-market programs have become increasingly complex. This is leading to a greater need to integrate genetics and genomics expertise earlier in the study planning process.
InformedDNA is experienced in working with clinical trial sponsors of research programs for neurodegenerative conditions. From clinical trial design to patient identification, recruitment and support, to clinical genetic counseling, test ordering, and interpretation services—we’re uniquely positioned to help your company.
Why do executives at pharma/biotech companies partner with us to deliver proven genetics expertise for neurodegenerative clinical trials?
- Meet/exceed enrollment goals and reduce time-to-IRB approval
- Reduce study costs
- Drive future program development
Patient Recruitement: A Proven Telemedicine Model for Remote Screening
You’re likely aware that <3% of patients participate in clinical trials. Oftentimes, barriers exist in the process that prevent the kind of engagement needed to meet defined goals of a study. We have more than 10 years of experience setting up remote genetic screening programs in collaboration with our biotech and pharma partners accelerating the time to clinical trial enrollment, and ultimately, patient access to new therapies. Learn how we helped one client by:
- Screening patients remotely for test eligibility
- Facilitating genetic testing
- Providing medical management to patients and their physicians for a rare neurologic disease
- Explaining the science of the clinical trial and generating buy-in
- Providing guidance for negative and uncertain test results
- Identifying at-risk family members, and providing outreach and support as well as facilitating testing for those individuals
Case Study: From Patient Identification to Post-Market Outreach
Lack of physician awareness, limited access to genetic testing, and delays in diagnosis prevent many eligible patients from receiving life-changing gene therapies. We help sponsors reduce the work needed at each trial site to make participation easier, increase efficiency, and mitigate risks – challenges that can stop your clinical trial in its tracks, but they don’t have to.
Learn how we partnered with a leading pharmaceutical company for one of its neurodegenerative clinical trials – providing patient identification and clinical trial support services all the way through FDA approval and post-market outreach to eligible patients.
FAQ: Answers to Common Questions about Genetics in Neurodegenerative Clinical Trials
The American Neurological Association estimates that with an aging population, approximately 8.4 million Americans will be affected with dementia by the year 2030. The rise in neurodegenerative diseases has been met by a call to action by affected patient communities as well as a significant increase in novel drug development and clinical trials. But, it has become clear that developing effective therapies for neurodegenerative diseases will require a more targeted approach than has ever been possible in the past.
We’ve addressed some of the most common questions sponsors pose about genetics-informed clinical research programs for neurodegenerative conditions.
InformedDNA is the largest full-service genetics advisory company in the U.S., with a suite of offerings for clinical trial sponsors and CROs designed to support clinical trials, natural history studies, and clinical research programs. Our services are optimized to reduce time-to-enrollment, increase screening efficiencies, improve patient retention, mitigate sponsor risk, and reduce clinical trial costs.