The first half of this year has really zoomed by! Earlier in the year, we were busy behind the scenes preparing for a major audit of our quality management system. We welcomed a new coordinator, Mo, and wished Amy a wonderful wedding day. There’s also plenty to report on the publication front, as well as further improvements to our website and Good Clinical Practice course, with more online education to come.
Due to the stay-at-home orders from NSW Health, many of our staff are working from home. Ongoing clinical trials are still running and enrolment remains open for many current and upcoming studies. If you have any questions or need to contact us, please send an email to firstname.lastname@example.org and someone will get back to you. Please wear a mask and stay safe!
First Patient in Painful Diabetic Neuropathy Study
This year, we opened a medical device study for Painful Diabetic Neuropathy. Neuropathic pain is an area of particular interest for Dr Russo and is one of the many conditions that we work on regularly.
Our team were able to enrol the first participant in the world for this study!
Contact us to learn more about studies like this.
New Study for Osteoarthritis of the Knee
We have just opened a new clinical trial for people living with Osteoarthritis of the Knee. This trial will be investigating an ongoing treatment option to reduce osteoarthritis pain and help restore function to the knee.
Our clinical team is excited by the potential of this new therapy for osteoarthritis pain.
Contact us for more information.
Upcoming Study for Neuropathic Low Back Pain
Our newest clinical trial is for people living with neuropathic low back pain. It is a first-in-human study exploring an intrathecal injection (into the space around the spinal cord) treatment to reduce pain.
We are currently short-listing potential candidates for the study.
Contact us to refer a patient to our clinical team or learn more about this study.
New Research Partnership
We commenced working with the University of NSW to assist with research into Quit Smoking products. Our team has been involved in some supply chain consultation, as well as investigational product distribution.
We are thrilled to be involved in a project aimed at helping people live a healthier life.
Contact us if you would like to learn more or discuss potential research partnerships.
Back Pain – Investigational Spinal Cord Stimulation Device
We are seeking volunteers for an upcoming clinical trial for people living with back pain. The study involves a temporary, investigational implantable device to reduce pain.
All medical costs are covered by the clinical trial and you will be reimbursed for your time.
Early Onset Sciatica Clinical Trial
If you have pain that radiates from your lower back down into your leg, you may have sciatica (also called lumbar radiculopathy) – a painful condition that affects millions of Australians each year. The most common cause of sciatica is a bulging disc in the lower spine, and the pain can be quite severe.
If you’re struggling with sciatica pain in your leg, you may qualify for the SALIENT Clinical Study, now being offered at select centres throughout Australia. The study is for an investigational, non-opioid single injection designed to relieve sciatica pain.
Osteoporotic Fracture Research
We are seeking volunteers to complete a one-time series of questionnaires to evaluate the indirect cost and physical burden of osteoporotic fractures in women aged 50 years and over.
This global study of 1,500 women will compare the indirect costs and physical burden for those with an osteoporotic fracture and those without. The study findings will better inform policy makers, clinicians and patients globally to help reduce the overall risk of fractures.
A very warm (and overdue) welcome to our newest clinical trial coordinator, Mohamad (Mo) Alhayaley! Mohamad joined us back in January and has been a wonderful addition to the Genesis team.
As a highly experienced pharmacist with a degree in clinical science, Mohamad brings a wealth of pharmacology and clinical science knowledge onboard. He also speaks fluent Arabic.
Amy Ties the Knot
On a beautiful winter afternoon in June, Amy married her partner in a wonderful ceremony with all of their family and friends present. The rain come later that night, but they do say it’s good luck for rain on your wedding day!
We wish them both a lifetime of happiness, and hope they create many beautiful memories together.
Quality Audit Passed
Genesis implements a Quality Management System (QMS) that complies with the International Quality Management Standard ISO AS/NZS 9001:2016.
Earlier this year, we passed a major external audit of our QMS. The constructive feedback received has led to further improvements to our QMS.
Successfully completing the rigorous audit process required for ongoing ISO 9001 certification demonstrates our commitment to providing the highest quality care for our participants and services for our customers.
We’ve been making some changes to the website that we hope will make it easier to navigate, including:
• A new page for Study Participants containing testimonials and links to our clinical trial information blogs.
• Lists of our completed medical device trials and musculoskeletal studies are now online. Lists can be filtered by year, phase, and type.
• Our blog posts can be filtered by category and tags.
Information pages for sponsors are also planned.
ICH-GCP Course Updates
Earlier this year, we moved our Good Clinical Practice Course to a new learning platform. The new platform has allowed us to completely automate our course certificates. It also allows us to create more interactive quiz questions. We hope that our students have found this new platform easy to use.
We have also posted a list of Frequently Asked Questions related to our online training courses, including answers to general queries, permissions, registration, certificates, and technical issues.
Research Foundations Package
We plan to release the next phase of our online clinical trial education later this year. The Research Foundations Package aims to provide new clinical trial staff (or anyone interested in joining the industry) with a comprehensive background to clinical trials, including:
- Introduction to clinical research
- Clinical trial study designs
- Clinical trial data
- Clinical research regulations, roles and responsibilities.
The course will run similarly to our ICH-GCP course, with learning pages, interactive content, and assessment quizzes.
Restorative Neurostimulation Trial Results
Two papers presenting results of the multifidus restorative neurostimulation clinical trials have been published.
We were the highest global enroller for one of the trials, the results of which informed the U.S. FDA Premarket Approval and regulatory approval from the TGA for use in Australia!
The therapy appears to be a good treatment option for appropriately selected patients with mechanical chronic low back pain.
Closed-Loop Spinal Cord Stimulation Trial Results
The final 24-month results of the “ECAP-controlled closed-loop spinal cord stimulation” clinical trial were published in March.
We were one of five sites to conduct the trial, which used an innovative “feedback mechanisms to provide consistent spinal cord stimulation” to treat low back and/or leg pain.
After 24-months of therapy, 89.5% of patients reported 50% or more pain relief, and 68.4% of patients reported 80% or more pain relief.
Multifidus-Sparing Radiofrequency Neurotomy
Dr Russo devised a new radiofrequency neurotomy (RFN) technique to treat chronic low back pain. RFN is a minimally invasive procedure that uses special electrode needles to deliver electrical current to the pain generating nerves supplying the facet joints of the spine.
The new approach aims to protect the multifidus muscle, which provides stability to the spine and is important for recovering from low back pain.
Neuromodulation Practice Trends in India
Dr Russo worked with Prof Paresh Doshi and Dr Preeti Doshi of the Neuromodulation Society of India to develop a survey aimed at exploring the barriers and limitations that clinicians in India experience regarding the use of neuromodulation therapies for pain.
The survey results highlighted a need to address the high cost of therapy, lack of awareness, and need for training.
Persistent Spinal Pain Syndrome
In this paper, a panel of international medical experts (including Dr Russo) discuss the issues with the diagnostic term “failed back surgery syndrome”. The term is often applied to patients who have incomplete relief or worsening of pain or symptoms after spine surgery. It is misleading and doesn’t help guide appropriate diagnosis and treatment.
The panel proposed the replacement term: “persistent spinal pain syndrome” type 1 (pain is not associated with the surgery) or type 2 (pain is associated with the surgery).
Interleukin-37 Reference Range
Interleukin-37 (IL-37) is a powerful anti-inflammatory molecule that protects the body from excessive inflammation. High levels are found in various inflammatory and autoimmune conditions, making it a potentially useful biomarker to diagnose such illnesses.
To this end, we collaborated with leading IL-37 researchers to establish a preliminary reference range for IL-37 in healthy adults by analysing published data. This will be of great value for clinicians & researchers investigating IL-37 as a potential biomarker in many inflammatory illnesses.
Pain Awareness Month
September is Pain Awareness Month
Pain Awareness Month is a global initiative to raise awareness about all things pain, including pain management, pain science, and pain research.
Pain studies make up a large portion of the trials run here at Genesis, which is why we will be joining specialist pain medicine physician Dr Marc Russo and Hunter Pain Specialists in getting involved in this initiative.
We have been filming a video to be release during September as part of Pain Awareness Month.