Through the mdtalk podcast and video series, we’re on a mission to highlight the most critical issues impacting clinical research, the patient experience, and the future of healthcare.
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[As this episode starts, LaQuinta introduces Tom before inviting Tarquin into the discussion]
Episode Summary
2022 was a big year for clinical trials. From supply chain disruptions and staffing shortages to the slowing of the MedTech boom of 2021, we have weathered some significant challenges:
- In 2022, supply chain disruptions were a big topic. A poll by the Pharmaceutical journal found 54% believed medicine shortages put patients at risk.
- In the first quarter of 2022, more than 50% of sites cited staffing as their top issue.
- The FDA approved 37 novel drugs in 2022, the fewest to pass since 2016.
- Decentralised clinical trials continue to gain traction, growing from 912 trials in 2020 to 1,293 in 2021, and the market is expected to grow by another 15% in the next five years.
- The growth of medical technology slowed during 2022 after record-breaking growth rates of over 16% in 2021.
In Episode 11 of mdtalk, host LaQuinta Jernigan, Chief Operating Officer at mdgroup, is joined by Tom Brazier, our Director of Decentralised Clinical Solutions and mdgroup’s Chief Executive Officer, Tarquin Scadding-Hunt.
They reflect on the past year and explore their predictions and hopes for 2023.
Clinical Trials – 2022: A Year in Review
The normalisation of Decentralised Clinical Trials
2022 was the year Decentralised Clinical Trials were finally ‘given a seat at the table’.
Although there is still some residual reluctance from some sponsors, 2022 was the year when DCTs and their methodologies were more normalised.
Medtech Continues to Take the Industry Forward
2022 was also a consolidation year for MedTech. Development rates slowed after an exceptional 24 months, enabling the industry to take stock quickly and embed new tech into Clinical Trial methodologies and processes.
Including cutting-edge technology in a trial’s methodology has become standard, and we look forward to seeing how MedTech continues to mature and move the industry forward.
Regulatory Uncertainty Around Decentralised Clinical Trials
The pandemic helped our industry leap forward in DCT development. Still, global regulators have been playing catch up within a sector that needs well-established and approved frameworks and compliance.
The EU paper on Decentralised Elements Within Clinical Trials, was published in December 2022. However, ‘real time’ developments by more nimble, on-the-ground trials designers and developers such as mdgroup means we’re currently operating in an environment that feels years ahead of our existing regulation.
Although this is an opportunity, as it means the industry can lead regulators on what we need from them to keep delivering remarkable patient experiences and outcomes, it did impact another trend of 2022: training and staffing.
The staffing & training gap
The pandemic took a significant toll on our industry, and the ripples are still felt across the globe.
Add to this the fast adoption rate of DCTs, increased use and normalisation of brand-new MedTech, and regulatory uncertainty. You have a recipe for the staffing and training crisis within the industry we’re currently experiencing.
2023 is a watershed moment for the clinical trials industry
Everything we’ve learned and experienced in 2022 allows us to take a step back, focus on what is really at the heart of a successful trial and focus all our attention on what matters – the patient.
Clinical Trial Predictions for 2023
Power to the Patients – Patient Empowerment is mdgroup’s Mantra.
Giving our patients power and control over their clinical trial journey is the heart of 2023’s most significant trend.
In this episode of mdtalk, LaQuinta, Tarquin and Tom discussed how we hope to see ‘Patient Power’ play out over the next 12 months:
Cross-Industry Collaboration
We want to see patients, sponsors, clinical researchers, and regulators working together to ensure the ongoing evolution, development, and success of the clinical trials space.
The industry is moving towards a more progressive approach to patient care, and we predict that we will see more acquisitions and collaborations from providers of care management and technology.
This will enable sponsors to access more seamless and cohesive methodologies and processes that genuinely impact the patient experience, leading to better patient engagement and more successful trials.
We hope the industry will also work together to lead the regulators. As front-line care providers, we are uniquely positioned to inform and educate our regulators on patient needs. We must ensure our newly established frameworks put patient care front and centre.
Scalability
This will result from the collaboration between care management providers and technology.
There can be cost increases during the rollout of a DCT, which must be considered when implementing a large-scale trial. It is likely one of the barriers more traditional sponsors face when adopting DCT methodology, especially when they are more comfortable with what they know – site-based trials.
However, we hope the collaboration between providers will start to create the efficiencies and outcomes needed to make DCTs and hybrid trials a more obvious commercial choice.
Indeed, a more patient-centric approach ultimately leads to better engagement, lower dropout rates, and better trial results in the long run. So, investing in virtual and hybrid methodologies is an investment in the success of a trial.
Giving Patients Choice
For us at mdgroup, offering our patients choice is crucial in facilitating remarkable experiences.
We hope this year, trials will move from ‘patients as subjects’ to considering them proactive partners, who must be engaged in their own care and outcomes.
Patients should have choices and options at every level:
- The logistics of where and how the trial is facilitated
- How much human content is right for them
- Access to their data
- Personalised MedTech
Trials would simply not go ahead if it wasn’t for our patients, so we have to listen to their voices and include them in the trial’s design at every stage of the journey.
This leads us to the most exciting prediction of 2023, the evolution of the DCT into the PHT; Patient-centric Hybrid Trials – truly putting patients first in clinical research.
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