GRS Newsletter – December 2020

What a turbulent year this has been. COVID-19 has forced change and devastation on people all around the world and we continue to monitor this daily. We are fortunate and grateful to be in a position where participants in our trials have been largely unaffected, and our staff are all keeping well.

Some of the biggest changes this year have been to the Genesis team. We have had changes in management, added two new investigators, and welcomed a beautiful baby boy.

We wish all of our participants, colleagues and clients a wonderful holiday season and we look forward to seeing you in 2021.

Study Highlights

Newcastle Research Institute - Genesis Research Services

Lead Site in World First Clinical Trial

Genesis received an award for being the number one recruiter and lead site for a clinical trial conducted at the end of last year. The trial involved a temporary, investigational, implantable device designed to treat back pain.

The next trial of this device is underway. We were the first to screen and implant a participant for this new study.

Newcastle Research Institute - Genesis Research Services

Promising Results with Subwave

Subwave is a new form of spinal cord stimulation waveform programming that aims to provide improved relief for patients with chronic neuropathic low back pain.

In the Subwave study, patients who are suitable for spinal cord stimulation (SCS) and who have a successful trial of SCS are implanted with a commercially available SCS device  and trial up to three Subwave programs.

Almost 30 participants have been implanted. 8 patients have completed their 12-month follow-up visit, reporting an average of 85% pain relief, as well as improved health and quality of life outcomes.

Current Studies

Newcastle Research Institute - Genesis Research Services

Back Pain – Investigational Spinal Cord Stimulation Device

This is a clinical trial for a new spinal cord stimulator device to treat chronic back pain.

Eligible participants with chronic back pain receive a temporary, investigational implantable device and trial it for 14 days. All medical costs are covered in this trial and participants are reimbursed for their time.

Contact us for more information.

Newcastle Research Institute - Genesis Research Services

Early Onset Sciatica Clinical Trial

Australians who are struggling with sciatica pain that radiates from the lower back down into the leg may be eligible to trial a new treatment. The SALIENT study is evaluating a non-opioid, single injection treatment that aims to provide long-term, sustained relief of sciatica pain.

Enrolment is quick and simple – no referral is required, and participants will be reimbursed for their time. There are 9 visits in total over an approximately 7-month period.

Contact us for more information.

Newcastle Research Institute - Genesis Research Services

Psoriatic Arthritis Clinical Trial

This is a clinical trial for people who have been living with psoriatic arthritis for more than 6 months and who have not had success with other treatments. The study involves a 4-month treatment phase, with an optional 2-year follow-up study for those able to continue using the study drug.

All study-related visits, tests and medications will be provided at no cost. Reimbursement for study-related travel will also be provided.

Contact us for more information.

Newcastle Research Institute - Genesis Research Services

Rheumatoid Arthritis Study

This is a post-market, observational study of a drug (Upadacitinib; brand name: Rinvoq™) used to treat rheumatoid arthritis. Patients with moderate to severe rheumatoid arthritis who have been prescribed Upadacitinib by their treating physician will be enrolled.

This is not an investigational study, but a real-world study to collect treatment and outcome information on patients taking the drug as per standard clinical practice. Patients will be followed up for up to 24 months.

Contact us for more information.

Team Updates

Newcastle Research Institute - Genesis Research Services

Goodbye & Good Luck, Dom!

Our Research Manager, Dom, announced mid-year that he was moving on to a new opportunity with the Hunter Medical Research Institute. As an integral part of Genesis for 7 years, Dom certainly made his mark on the growth of the team and research centre as a whole.

We are thrilled to see him pursuing his passion for medical research development and know that he will continue to push boundaries in this industry.

Congratulations Dom and we wish you all the best!

Newcastle Research Institute - Genesis Research Services

Katie’s New Arrival

At the end of October, we said goodbye for a little while to Katie as she left to go on maternity leave.

Two weeks later, Katie welcomed a beautiful little boy into the world! Cameron Joseph Hart – born 12th November 2020.

Congratulations to the Hart family!

We look forward to the day that Katie comes back to us and hope that she will visit soon!

Newcastle Research Institute - Genesis Research Services

Welcome, Elle!

A very warm welcome to our new research manager, Eleanor (Elle) Ramsey! Elle comes to us with extensive experience in clinical research from numerous universities and hospitals in NSW.

She is already proving to be a great fit within the team and is keen to meet all of our valued clients and participants.

Please feel welcome to reach out and introduce yourselves at Elle@genesisresearchservices.com

Newcastle Research Institute - Genesis Research Services

Trial Coordinator Expansion

In 2021, our team is set to grow again as we welcome new trial coordinators to Genesis.

Our recent campaigns have brought us some phenomenal candidates which demonstrates the level of quality personnel in our region working in medical research.

As we move into the new year, we will be starting many new studies, and with our new staff, we will continue to offer the same high level of service to our valued clients.

New Investigators

Paul Mansfield - Newcastle Research Institute - Genesis Research Services

Dr Paul Mansfield

Dr Mansfield is a local rheumatologist with a background in immunology. Dr Mansfield is fascinated by the immune system and actively seeks to assist people living with a range of rheumatological conditions to have a higher quality of life. He is passionate about offering people greater treatment options and keeping up to date with new therapies.

We look forward to working with Dr Mansfield on our rheumatological projects.

Q4 dermatologist - Newcastle Research Institute - Genesis Research Services

Dr Paul Chee

Dr Paul Chee is a local dermatologist who joins our team in 2021. This is an exciting time for Genesis as we expand our indications once again to provide research services and trial options for people in our community. Dr Chee is the Head of Dermatology at John Hunter Hospital and also has a private practice at Valentine. He is dedicated to resolving dermatological conditions and joins Genesis to facilitate the development of potential new treatment options.

We look forward to working with Dr Chee on Dermatology studies.

Other News

Newcastle Research Institute - Genesis Research Services

GCP Course Updates & Statistics

Over 1,000 people have now completed our online Good Clinical Practice training course and over 2,000 have registered!

Thank you to all who have completed the course and provided feedback. We have made several improvements to the course and further updates are planned.

We are proud to be a recommended ICP-GCP training provider for NSW Health and the University of Queensland.

Newcastle Research Institute - Genesis Research Services

PAIN2020 Virtual Conference

Dr Russo proudly hosted a virtual pain conference – PAIN2020 – on November 14-15.

Dr Russo gave presentations on medicinal cannabis for pain, radiofrequency capsulorrhaphy, and the science of lifespan extension. Our previous manager, Dom, gave a presentation on partnering in research.

The conference offered virtual workshops, industry sessions, and round table sessions with experts in the field.

Publications

Newcastle Research Institute - Genesis Research Services

Saluda Avalon 12 Month Results

We were one of five sites to conduct this clinical trial of “closed-loop” spinal cord stimulation for patients with low back and/or leg pain.

At the 12-month follow-up, the majority of patients reported 50% or more pain relief (76% of patients for back pain, 79% for leg pain, and 81% for overall pain). More than half of the patients reported 80% or more pain relief.

Read the full article here.

Newcastle Research Institute - Genesis Research Services

HF10 SCS Upper Limb & Neck Pain

We were one of three sites involved in this clinical trial to study the safety and effectiveness of high frequency spinal cord stimulation for chronic upper limb and neck pain.

A total of 30 participants received a HF10 SCS implant. The average pain relief at 3 months was 65% for neck pain and 66% for upper limb pain, which was maintained at 12-months, improving to 72% for neck pain.

Read the article outline here.

Newcastle Research Institute - Genesis Research Services

Complex Regional Pain Syndrome Immune Biomarkers

This is the second research paper to come out of our collaborative investigator-initiated study with researchers from The University of Sydney and Macquarie University.

We found evidence of reduced levels of an important anti-inflammatory molecule known as interleukin-37 in CRPS patients, as well as involvement of the immune-activated Kynurenine pathway, which may be linked to pain in CRPS.

This research is an important addition to the scientific literature that we hope will lead to better diagnosis and treatment of CRPS.

Read the article outline here.

Newcastle Research Institute - Genesis Research Services

Painful Diabetic Neuropathy Inflammatory Biomarkers

In collaboration with researchers from Sydney University and Macquarie University, we analysed the blood of diabetic patients with or without neuropathic pain.

We found higher levels of two inflammatory molecules and two inflammation biomarkers in the diabetic patients with neuropathic pain.

Findings like this may help us to better understand what causes some diabetic patients to develop neuropathic pain.

Read the article here.