How ARTIDIS collaborated with patient experts to co-design a compliant, engaging, and efficient clinical trial protocol

Results

“This is such an opportunity to help people feel like partners, like part of a team. I would love to see this become a leading practice across the trial space.”
ARTIDIS Panel Participant

Challenges

Medical technology company ARTIDIS has developed the world’s first nanotechnology platform for tissue analysis. ARTIDIS is a ground-breaking tool that can diagnose cancer in under three hours, detect its aggressiveness, and enable personalised treatment planning based on nanomechanical biomarkers. 

 

As an early-stage start-up, ARTIDIS initially approached merakoi for patient-led market research to guide the business model and commercialisation strategy for this pioneering cancer diagnostic device. (Read the case study)

 

Subsequently, the ARTIDIS team were initiating clinical trials across the US and wanted merakoi’s support to optimise the clinical trial design. Ultimately ARTIDIS wanted not only to comply with good clinical practice standards but to co-design a trials protocol that was truly patient-first – to maximise participation and optimise diverse participation, minimise dropout rate, and bring this life-changing device to patients faster.

Process

Patient-centric clinical trial co-design to maximise enrolment and engagement

 

merakoi curated a Patient Experience Panel of three patient experts to collaborate with ARTIDIS. The panel brought a wealth of professional experience within clinical trial optimisation, public health research, and patient engagement, alongside personal experience as breast cancer patients.

 

We then ran a virtual feedback panel scrutinising every touchpoint of the clinical trial protocol. Thanks to the unique combination of professional and personal disease-specific expertise, our patient experts could provide extremely rich insights into the trial protocol, study design, and best practices for patient engagement. For instance, one patient expert is both a healthcare lawyer and a metastatic breast cancer patient. 

 

We then validated and consolidated the panel’s findings by interviewing an additional two patient experts from one of ARTIDIS’ current study sites, to gather insights into optimising enrolment and site engagement.

Outcome

Developing a more effective clinical trial protocol for today and tomorrow

 

ARTIDIS’ panel co-designed the protocol for the ongoing clinical trials, optimised for compliance, engagement, and efficiency. The panel also established a clear patient-orientated narrative to communicate the benefits and outcomes of the trial, and structure the consent form appropriately. Alongside this, the panel recommended different channels to provide patient support, to help minimise participant dropouts.

 

ARTIDIS’ panel also created a best-practice clinical trial playbook to guide future trial design. Within this playbook, the panel identified six key principles as the foundation for optimum patient engagement during clinical trials and pinpointed four crucial steps and the essential staff needed to optimise patient enrolment and participation. 

 

The clinical trials for ARTIDIS are currently ongoing, and the best-practices learned will be taken forward into future trials. merakoi's support is helping ARTIDIS accelerate towards their mission to redefine how cancer is diagnosed and treatment planned, with this revolutionary world-first device.

 

“This peer session was an eye-opener for me: patient-led!  Focusing in particular on patient online community leaders and influencers who not only understood clinical trials but could speak for their communities.”

Marija Plodinec, CEO, Artidis

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