Title: Decentralized Trials - No Going Back
Link: https://www.oracle.com/in/industries/life-sciences/health-sciences-connect/sessions/
Time: 23 April, 2021 - 3.05 pm (Australia/Adelaide ACST).
Avance Clinical CEO Yvonne Lungershausen, shared the company's insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success. Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource and eConsent.
"DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials," said Lungershausen.
"The pandemic has been the catalyst in speeding up the adoption of decentralised clinical trial methods, as people stopped participating in trials and visiting clinics. Trials have stalled putting lives and significant investments at risk."
Yvonne Lungershausen said there are considerable benefits to DCT's including:
- Reduce the scheduling and travel burden on patients - providing care from the comfort of the patient's home.
- Connecting patients to trials on a global scale - patients that were otherwise inaccessible under more traditional trial protocols are now available.
And she said challenges include:
- Missed human-to-human contact and continuity of patient care
- Investigational product distribution to more remote destinations
- Oversight of compliance and study procedures in the patient's home
The presentation also covers advances in artificial intelligence (AI), machine learning, cloud computing and blood self-collection devices which are all revolutionising the decentralized clinical trial process.
- Wearable devices are demonstrating enormous potential whether worn as a wrist strap or an adhesive patch on the body. AI-embedded capabilities allow these devices to measure a patient's heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data real-time.
- Video calling and electronic reminders, can improve patient compliance in trials - prompting participants to take their medication at the right time or to record in their electronic diary development.
- Technologies are developing to allow patient-centric sampling (self-collection of specimens) with devices that require the use of a lancet and finger prick whereas others do not, making clinical trials even more convenient.
Take the Quiz - Test your Knowledge about Australian Clinical Trials here:
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About Avance Clinical
Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research services with its highly experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Learn more at http://www.avancecro.com.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic - speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5-6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons
Media Contact:
media@avancecro.com
Source: Avance Clinical
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