Regulatory support: managing research set-up to gain real-world data for adoption of clinical innovations

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Overview summary:
Health innovations and ideas frequently require robust research evidence to demonstrate clinical and cost efficiency, or structured real-world trials to support scale and speed of adoption. WFC provide a range of specialist support services in regulatory affairs.

An example of the services that we can provide is illustrated through the case study of how WFC supported Electromedical Products International, Inc (EPII), to gain real world-data for the adoption of an innovative medical device at scale.
Challenge identified and actions taken :
EPII and the UK distributor The Microcurrent Site (MCS) offer the Alpha-Stim AID medical device. Alpha-Stim AID is proven to be clinically safe and effective in the alleviation of anxiety, insomnia and depression.

To enable EPII and MCS to offer the Alpha-Stim AID to patients in the NHS, research data was required to be submitted to the National Institute for Clinical Excellence (NICE) to evidence the clinical and cost effectiveness of the device when used in an NHS setting. Neither EPII nor MCS had any experience of designing and submitting research studies in the UK.

WFC took a protocol outline and developed it into a full clinical trial protocol with essential documentation following engagement with all stakeholders.

Regulatory submissions were made to the Health Research Authority (HRA) for approval (inclusive of ethical favourable opinion), to the National Institute for Health Research (NIHR) for inclusion onto their portfolio, and to an NHS Improving Access to Psychological Therapies (IAPT) service in the East Midlands.

WFC designed a site initiation training package which was attended by over 60 members of the IAPT team over 2 days to ensure successful and compliant trial delivery.

All aspects of design and delivery were undertaken on behalf of EPII and MCS who were provided with regular progress reports.
Impacts / outcomes:
The clinical trial, which had been planned for many years, was designed and initiated in just 15 days of WFC consultancy time, enabling EPII and MCS to gather the valuable clinical and cost effectiveness data sooner than expected.

EPII and MCS were able to delegate all aspects of set-up to WFC with confidence, thus reducing the burden upon their teams.

Extensive initiation training ensured a prompt start to recruitment and rapid generation of data.

Strong working relationships with all stakeholders ensured a well-designed study which quickly processed through regulatory approvals. WFC were also able to facilitate conversations with the relevant Clinical Commissioning Groups (CCGs) and patient advocacy groups, with the result that real-world data collection is near completion and ready for submission for adoption of the device in the NHS.
Supporting quote for the innovation from key stakeholders:
“Everything was great and highly professional”: Steve Hutchinson, MCS Managing Director.
Which local or national clinical or policy priorities does this innovation address:
NHS IAPT services are committed to initiating treatment for 75% of people within 6 weeks of referral, and 95% within 18 weeks of referral, a clinical target formalised in policy framework Achieving Better Access to Mental Health Services by 2020. Alpha-Stim AID provides a maintenance therapy for people whilst on the waiting list following referral, thus enabling the target to be achieved. Additionally, a significant proportion of people using Alpha-Stim AID achieve full recovery, and so do not require further individualised treatment from NHS IAPT. This represents a considerable saving, and is in line with the NHS Mandate 2017/18 priority to balance the NHS budget and improve efficiency and productivity. WFC support clients to meet the national requirement for a technology appraisal from NICE, which is based upon clinical and economic data. The NHS is legally obliged to fund and resource treatments recommended by NICE’s technology appraisals within three months, as reflected in the NHS Constitution. As such, WFC are experts in navigating local and national priorities and processes. 
Plans for the future:
EPII and MCS will shortly be submitting the clinical trial data to NICE for technology appraisal. Recommmendation for use in the NHS is anticipated due to the high-quality clinical and economic data gathered, working relationships built with clinicians, NHS IAPT service managers, and Clinical Commissioning Group leads, in addition to support from patient groups.

WFC are ready and available to support other users of the Meridian platform to navigate regulatory affairs issues.
Contact for further information:
Mark Terry, Senior Consultant: mark@wendyfisherconsulting.co.uk
Luke Brewer, Senior Consultant: luke@wendyfisherconsulting.co.uk
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