Tawazun Health Global Fibroscan® Service

Clinical Trial Brief 2021

Brief for the delivery of global Fibroscan® services by Tawazun Health

Louise Campbell MSc (Hons), CERT MHSC, RMN, RN

Medical Director

Overview

Tawazun Health the United Kingdom’s only FibroScan® (Vibration Controlled Transient Elastography) delivery service. A one stop FibroScan® service unblocking the pathway and taking the stress out of real time liver assessment for the patient, physician and researcher in any location.

Experience and quality matter in FibroScan®.

Fibroscan® is currently internationally one of the primary recommended methods of assessment and provides both an assessment of liver stiffness and a controlled attenuation parameter for the assessment of steatosis (CAP) required for identification/assessment and monitoring of many liver conditions including Non Alcoholic Fatty Liver Disease (NAFLD), Non Alcoholic Steatosis Hepatitis (NASH) independently and in association with other liver related conditions. CAP also enables enhanced screening and patient selection.

FibroScan® and AST (FAST) is highly predictive of active NASH (Newsome et al 2020) and the best performing non-invasive assessment of this condition. It can reduce screen failure rates and improve the identification of those who require liver biopsy. FibroScan® has the lowest rate of indeterminate diagnosis (J Boursier et al 2020), with a high threshold for the identification of early fibrosis when performed by skilled operators. The opportunity to reduce your indeterminate zone to 20%.

At Tawazun Health we have the experience and capability to ensure the running of your clinical trial recruitment, operates smoothly with experts performing the FibroScan® you need.

FibroScan® is rapidly becoming one of the essential diagnostics for the monitoring and assessment within the clinical trial pathway, as it will in most settings, be the real-world device of choice for clinicians and patients.

In early phase or small studies, it can only take a few scans with a A-wave or E-wave rib echo to affect the quality and validity of the scans, jeopardising the data for the study, why take that risk?

It is therefore essential that all FibroScan® exams performed to locate subjects and within protocols are of the highest quality, preserving the validity of the study, being performed by highly experienced scan staff.

Tawazun Health is a specialist service providing all equipment, trained staff who can deliver your FibroScan®. An immediate, risk-free assessment of liver fibrosis when your protocol requires it, in the location you require it.

Tawazun Health uses only the very latest mobile FibroScan® equipment with SmartExam with continuous CAP on all models.

Tawazun Health staff are skilled and experienced in scanning patients including those with high BMI and complex needs.

Tawazun Health scan staff continually remain updated on FibroScan® techniques and the expanding areas for use.

This Business brief sets out how Tawazun Health as the only independent provider of complete Fibroscan® services, is best placed to support your research needs delivering excellence and quality.

A Management Cost Opportunity for Clinical Research

The consequences of delayed recruitment cannot be underestimated in the areas of Non-alcoholic Fatty Liver Disease (NAFLD) or Non-alcoholic steatohepatitis (NASH) from the impact of COVID-19 to the pharmaceutical industry in developing the treatment options, study timelines and post COVID recovery.

This presents an opportunity for protocols to enhance the location of the correct participant with FibroScan® exams, delivered in speciality, other location or even in the community / home settings. This allows improved resource planning, participant satisfaction and protocol implementation.

Tawazun Health removed the need for investigators to purchase equipment and have specially trained staff. Increasing access to FibroScan® to everyone.

Tawazun Health can perform all your protocol FibroScan® assessments, with the highest quality devices, experienced staff and quantified reports.

These can be provided anywhere in the UK – whether in the research centre, remote clinics, primary care settings or the participants home if this is required. Location, lack of equipment or skilled staff are no longer barriers to the recruitment and delivery of FibroScan® in any research protocol.

Fibroscan® Technology

Fibroscan® is the most reliable non-invasive surrogate marker of liver stiffness. It is quick, well tolerated by patients and highly cost effective. When performed by an experienced practitioner results can be immediately made available to the Clinician and patient.

Fibroscan® is published in > 2500 (peer reviewed) research articles and documents. International guidelines have been published recommending transient elastography (Fibroscan®) as one of the primary methods of assessment. FibroScan® is now evidenced as a monitor for the improvement in liver condition in NAFLD and NASH studies.

Benefits of Fibroscan®

Fibroscan® liver scan is a specialised time efficient non-invasive, painless assessment that does not require an inpatient admission and gives ‘real time’ results. It is well liked by individuals and has high participant / patient engagement.

Fibroscan® can be used in adults and children and is safe for use with implanted medical devices and in pregnancy (Echosens 2016).

Patient experience

FibroScan® liver scanning greatly improves participant experience, identification and safety in any setting and the engagement is high.

Tawazun Health Quality

100% of all scans undertaken completed

KPa IQR: Average 0.7

CAP IQR: Average 36%

100% satisfaction

Tawazun Health Services

For Tawazun Health FibroScan® services to provide the ideal match and solution for you and your individual protocols we will require detailed information where known and would do so under a non-disclosure agreement.

Information we would require will need to include but not limited to –

  • The timeline and order of those countries in study initiation
  • The number and countries in which recruitment will take place
  • The projected timeline to first patient first visit (FPFV) in these countries
  • The duration of the study and visit schedules where FibroScan® is required
  • The number of sites to be used and planned number of participants for each study site
  • The schedule for FPFV will need to be known for each individual site

This information will ensure that Tawazun Health staff are fully available in each country to deliver on and maintain the study schedule on time

Tawazun Health FibroScan® options

Using Tawazun Health FibroScan® services we aim to make it easy for you to include FibroScan® in your protocol and calculate the associated costs that work through many pathways and can deliver a bespoke service providing quality, value and outcomes.

Examples of our models include the following:-

Individual Protocol Model:

  • For Tawazun Health FibroScan® Service a non-reimbursable Clinical site activation fee to be paid in advance
  • Where whole protocol training is required beyond FibroScan® exam delivery, additional fee’s will be charged
  • The cost of each commercial FibroScan® performed is based on specific protocol details* and is inclusive of equipment, trained staff, scan and results
  • For any FibroScan® performed outside of a study site location, reimbursable travel costs will be applied in relation to the registered study site for that participant’s home visits
  • For those studies with small numbers Tawazun Health will endeavour where possible to have the same scan staff member perform all scans on the same equipment to deliver standardisation and consistency for the protocol
  • All FibroScan® elastograms are reviewed for accuracy

Time specific model:

Tawazun Health can provide daily, weekly and monthly hire options in a specific location

  • Daily hire is based on a minimum of 6 scans (3 hours) being required
  • For a full day, based on a 6-hour clinic session per Tawazun Health scan staff. Specific time / day requirements can be accommodated
  • Allows for multiple protocols and multiple scan staff for large scan requirements

Inhouse FibroScan® provider Model:

  • Tawazun Health can be hired to provide your complete inhouse service
  • Enabling multiple site and protocol options
  • Providing an entire service which can be delivered in fixed site locations, tertiary locations and outreach, home visits as required
  • Increasing site location and participant recruitment options
  • Full services can be delivered on annual or 6 monthly contracts and are individually priced to meet the needs required

Health Service or rapid FibroScan® participant locator Model:

Tawazun Health can be hired by you to provide services to local health services to assist in the location and identification of suitable patients to be considered for clinical trials

  • FibroScan® waiting lists in many areas are now post COVID-19 over 12 months which blocks patient care, assessment, and clinical participant location.
  • Over one third of all current FibroScan® devices in the NHS are not CAP enabled and unsuitable to identify those with possible steatosis which blocks patient care, assessment and clinical trial participant location specifically in NASH / NAFLD areas
  • Providing Tawazun Health FibroScan® to support and deliver scans in areas can assist in unblocking the pathway, increasing identification of potential suitable trial participants.
  • Benefits include Increasing awareness, recruitment from more diverse populations, site location and participant recruitment options
  • Provision of a fixed number of scans, over a fixed time in a fixed location for defined criteria

If your requirements are not detailed, then we will work with you to specifically design the service that best meets yours and your participant needs.

Case Study

Tawazun Health have experience in delivering high quality remote and mobile FibroScan® services.

Drug and Alcohol Homeless scanning:

Three diverse locations in three days across one county: Hostel, Hotel, and drop-in centre – one operator

100% of scans performed. 60% abnormal: 45% had high liver fat and of these 77% Grade 3 steatosis.

Health Worker feedback:

“It was obvious that the people you scanned were very much engaged, partly because you took the service to them in their environment, but also because you provided them with information that was easy to interpret. It was also evident to me that people do care what is

going on in their bodies and by seeing for themselves the immediate result on a screen, helped individuals acknowledge and understand the reality. More importantly you gave them hope that these results can be changed and improved by following small but positive changes.

For me personally it completely challenged my belief that a person with harmful alcohol consumption would be doing more damage to their liver, than a person following an unhealthy diet with lack of exercise.”

Current Clinical Trial Partner

“Tawazun health was an excellent partner to work with and exceeded our expectations during our experiential trial.

XXXXXX was professional and extremely knowledgeable and was able to explain, in detail, the state of our participants’ Liver health.

Educating our participants on the importance of their liver health allowed them to appreciate the trial and the benefits they could gain from our it.

We have had amazing feedback from our participants on the easy and high standard of the scanning procedure.

They would be highly likely to visit Tawazun Health in the future for independent check ups.

We as a company will keep using Tawazun Health for all of our liver scan referrals as we trust the procedure and the results”.

Summary

This brief sets out to give you an understanding of the depth of our experience, knowledge and research provision options. Tawazun Health has identified the need to deliver high quality experienced options to utilise FibroScan® which is the best in participant friendly liver scan technology.

Tawazun Health is uniquely placed as the only independent provider of FibroScan® services in the UK with the ability, equipment and expertise to scan adults, children and obese patient populations.

Tawazun Health is the only independent provider of complete FibroScan® services in the UK and is registered in Australia, if you require Tawazun Health Services in other international locations then please contact us directly so we can best meet and deliver your needs.

References

Newsome, P N. et al 2020 FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study, The Lancet https://doi.org/10.1016/S2468-1253(19)30383-8

Boursier, J. et al 2020 Noninvasive assessments to identify patients with advanced fibrosis due to NASH: Screened population from the REGENERATE trial. Oral presentation abstract 0056. AASLD digital meeting November 2020