Faster, smarter, more inclusive: The UK roadmap for cutting-edge clinical research

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The government update of August 2025 presents an ambitious and detailed plan to fundamentally transform the UK system for clinical research — supported by significant investments and structural reforms.

The focus is on three key changes:

- the transfer of research from hospital to outpatient community,

- the consistent use of digital innovations and

- the greater prioritization of prevention over treatment.

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Four strategic pillars guide these reforms:

-faster access to clinical trials,

- tackling major health challenges,

- reducing inequalities through inclusive research and

- creating a world-class environment for life sciences.

Special features of the roadmap include the annual investment of £1.6 billion for research through the National Institute for Health and Care Research (NIHR), with the NHS benefiting from significant financial returns, particularly in subsequent intervention studies. The new UK Clinical Research Delivery (UKCRD) program focuses on cross-sector collaboration, accelerated study setups (maximum 150 days) and promotes research offerings in primary and community care for wider participation.

A key part of the strategy is the Voluntary Branded Drug Pricing, Accessibility, and Growth Program (VPAG), which expands staffing capacity and creates new commercial research centres.

The following initiatives are particularly noteworthy:

- Improved study set-up plan: This “digital-first” approach removes unnecessary bureaucracy when approving studies; the results of the first two phases were already published in 2025. The results are continuously monitored.

- “Right Research, Right Setting” initiative: Research is located where patients receive their regular care — particularly in the community and primary care — to enable wider participation and more relevant insights.

- Proactive portfolio management: The active involvement of NIHR in industry (advisory group, optimised contract drafting) shows the shift towards partnership and early problem solving.

The update also describes progress beyond Lord O'Shaughnessy's recommendations: such as faster national contract value reviews (NCVR) for commercial studies, compliance with 60-day deadlines for regulatory approvals, the introduction of a clinical trial accelerator, and the publication of transparency data at site level.

In addition, the NHS consistently integrates research implementation into everyday working life — with new guidelines, targeted promotion of personnel development and initiatives to expand digital volunteer registers. As part of the “Be Part of Research” campaign, the government has set the new goal of reaching 2 million volunteer registrations by March 2026. Innovations in confidentiality agreements, pharmacy guidelines and optimised contracts are already reducing negotiation times and regulatory hurdles.

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Despite the budget cut in the core budget, Germany continues to invest massively in research. The recently presented draft budget 2026 by Federal Finance Minister Lars Klingbeil sends mixed signals for the research landscape: While the section plan of the Federal Ministry of Research, Technology and Space (BMFTR), at 21.3 billion euros, is one billion lower than 2025 — and somewhat lower than 2024 — there are still strategic investment priorities.

Despite the nominal cut in the core budget, the Federal Government is focusing on strategic compensation: A total of 17.1 billion euros are earmarked for research and development in 2026, supplemented by Germany's High-Tech Agenda with 18 billion euros by 2029. “Research for seriously ill people and people with rare diseases” is being explicitly promoted. The 1,000 heads plus program to attract international scientists is supported with over 600 million euros in this legislative period.

Despite budget consolidation, there are still opportunities for our clients: The focus remains on targeted promotion of medical innovation and evidence-based therapeutic approaches even in difficult times.

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Crises as a catalyst for humanity: Thoughts from an entrepreneur

As I flipped through the latest economic forecasts for 2025 this week — geopolitical uncertainties, trade conflicts, structural challenges — I had an idea that Carel van Schaik would probably have formulated as follows:”We live in a state of emergency, but that is not our fate.”

The familiar uncertainty

The parallels between the current global economic situation and the COVID-19 pandemic are striking. Then as now, we face complex, systemic challenges that shake our usual structures. Back then, it was interrupted supply chains, lockdowns and a historic economic slump of 4.9 percent. Today, it is US tariffs, geopolitical tensions and a German economy that is barely stagnating.

But what concerns me the most as an entrepreneur is not the crisis itself — it is the reaction of people in my company to it.

The evolutionary heritage within us

Van Schaik would say:”Cooperation was the only life insurance we had.”

This primal human capacity for cooperation — which has kept us alive as a species for over 99 percent of our history — is just in its purest form.

During the pandemic, I saw my team spontaneously develop digital solutions, share workplaces, and take care of colleagues who were in quarantine. Today, in the face of economic uncertainty, I see the same willingness to cooperate: people who go beyond their job descriptions, take on responsibility and seek solutions together.

I'm proud of the people I get to work with!

The current economic challenges will pass as the pandemic has passed. What remains is the recognition that we are only as strong as our weakest link, but together we are stronger than any crisis.

At a time when 90 percent of people feel that our society is divided, the answer does not lie in more optimization or resilience training. It lies in a conscious return to what makes us human: listening, withstanding other opinions, empathizing, negotiating bold solutions together.

That is community spirit. That is being human. And that's our biggest opportunity.

As an entrepreneur, I see it as my task to create spaces in which these primal human abilities can flourish. After all, it is not algorithms or strategies that get us through crises — it is people and their innate ability to cooperate.

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On Thursday, July 24, 2025, as part of the Red Town Hall, the 17th Berlin Science Prize awarded. The Governing Mayor of Berlin, Kai Wegner, honored outstanding scientific achievements that significantly contribute to the excellence and innovative capacity of Berlin as a center of science.

The personally invited guests included Dr. Caroline Schmidt-Lucke, who, together with numerous representatives from science, politics and business, took part in the award ceremony and the subsequent reception. The event was a special opportunity to recognize the importance of research and innovation for the future viability of the capital.

The one with Main prize endowed with 40,000 euros was awarded to an institution whose work has set groundbreaking impulses for Berlin's scientific landscape. In addition, the Young Talent Award in the amount of 10,000 euros awarded to a young scientist under 35 years of age who further strengthens Berlin's profile as a science hub with innovative ideas.

This year's award ceremony once again underlined the diversity and international appeal of Berlin's research. Following the award, the guests took advantage of the opportunity to exchange ideas and network at a festive reception.

We warmly congratulate all prize winners and are impressed by their outstanding commitment to science and innovation in Berlin!

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Europe and medical devices — quo vadis?

The European medical device competent authorities on reform of the EU regulatory framework for medical devices have set important steps for the future of the medical technology market. Especially for manufacturers of medical devices, there are now decisive impulses to adapt to upcoming requirements.

Where is Europe heading?

The core message:

- More cooperation

- Clear rules

- a more centralised approach.

The aim is to make the approval and monitoring of medical devices in Europe safer, more efficient and more predictable.

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What does that mean in practice?

• Stronger coordination at EU level: The EU wants to work in a more uniform and coordinated way in order to avoid bureaucratic hurdles and different interpretations.
• More centralization: Individual tasks, such as monitoring and scientific advice, are to be bundled across Europe. This makes processes more predictable and comprehensible for manufacturers.
• Focus on patients: At the same time, a flexible, patient-centered approach remains important — so that innovations reach people just as quickly and safely.
• Simplification instead of bureaucracy: Regulations should reduce comprehensible and unnecessary costs. Small companies or startups in particular also benefit from this.
• Fair costs and stable resources: There should be sufficient personnel and resources — at European and national level. The costs for companies should remain transparent and comprehensible.

What's next?

The European Commission is already working on emergency measures and a basic evaluation of the system. The aim is a clear roadmap, more resources and possibly new legal bases for centralized management and support. The aim is a stable, innovation-friendly and globally competitive environment — with a scientific basis and access to expert knowledge at EU level.

What does that mean for manufacturers?

• Prepare for more consistent processes: The requirements for all market participants are likely to become more transparent and comparable.
• Opportunities for smaller companies: The planned relief and support will enable fairer access to the market.
• Better support: More consulting services and clearer guidelines for manufacturers are planned in the future.

Conclusion: Europe is in a period of change — with the aim of becoming a modern, strong and fair market for medical devices. As a manufacturer, anyone who recognizes and prepares for these opportunities can benefit from the innovations.

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KLIFO workshop by BPI and BVMA for digitising clinical studies

MEDIACC was on the topic at the 6th KLIFO workshop ”Digitalisation in clinical research: practical solutions for computerised systems and AI“ represented in Berlin on June 30, 2025. The renowned specialist event is organized jointly by Federal Association of Pharmaceutical Industry (BPI) and the Federal Association of Medical Contracting Institutions (BVMA) organizes and is considered one of the most important platforms for exchange between authorities, sponsors and CROs in German-speaking countries

The workshop covered central topics of digital transformation in clinical research. The focus was on Validation and auditing of computer-aided systems with a risk-based approach and the practical implementation of Guideline for Computerised Systems.

Dr. Marc Brooks (elderbrook consulting GmbH) shed light on the auditor's perspective and provided practical experience in evaluating modern technologies. Dr. Torsten Stemmler (BfArM) offered insights into the regulatory perspective and current regulatory requirements. The innovative World Café format facilitated intensive exchange on three subject areas: Validation of AI systems, Evaluation of electronic source data systems and AI in decentralised studies.

The KLIFO workshop made it clear that the Digitalisation of clinical research continues to gain momentum. The discussions on traditional computerised systems versus AI-powered applications identified opportunities and challenges.

The PubMed.ai practical test: currently more shadow than light

In the course of advancing digitalization in healthcare, we repeatedly come across innovative applications that should make it easier for us to research and evaluate medical literature. One of these digital solutions is PubMed.ai, which uses artificial intelligence to optimize searches in the well-known PubMed medical database.

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We've tested PubMed.ai for you and would like to share our experiences.

After an intensive test run of PubMed.ai, our conclusion is clear: The application is currently not yet suitable for professional use.

Here is an overview of the most important observations:

1. English only — a clear minus point

Even on the first try, it is noticeable that PubMed.ai only understands English input and only gives English output. For many users in other language areas, this is a significant disadvantage, as convenient research in their own language is not possible. That is not in keeping with the times.

2. No processing of Layman's language

Even those who formulate medical questions in everyday language immediately reach limits. PubMed.ai only understands precise, technical language queries — another obstacle for users without in-depth medical knowledge.

3. Classic search queries are interpreted as text

It's interesting that classic PubMed-style searches (e.g.”Buzzword AND Buzzword AND Buzzword“) can be treated as running text by PubMed.ai  This leads to a different presentation of results, which can be quite exciting for experienced users, but also to unexpected results.

4. Weaknesses in bibliographic references

Another shortcoming: In the edition text, only some references are usually mentioned directly, while further references are listed — but without clear citations in the text. This makes it difficult to understand the results and is inadequate for scientific work.

5. Lack of top-class sources

Anyone hoping for high-quality, relevant literature will be disappointed: The sources shown do not meet the expectations of well-founded research. Many relevant and high-ranking publications are not even displayed.

6. Inappropriate sources

A closer look at the titles and summaries of the proposed literature makes it clear that the selected sources are not suitable for the question posed. This significantly reduces the usefulness of the application.

7. Too narrow focus in results

The generated answer texts are heavily focused on a very specific sub-question and do not provide a comprehensive overview. This is not helpful for users who want to quickly gain a broad insight.

Our Conclusion

PubMed.ai currently cannot be recommended for professional use in medical literature research. The developers still have a lot of work ahead of them to make the practical application. Until then, the classic PubMed search remains our first choice or working with professional LLM, which focuses the search on PubMed and then enables us to get started.

We'll stay up to date for you and report as soon as there's news or improvements!

Do you have any questions or your own experiences with PubMed.ai? Feel free to write to us!

Your MEDIACC team

... MEDIACC is still working!

As is now a good tradition with us, a team of MEDIACC runners signed up again this year for the 5x5 team relay across Berlin's Tiergarten. The track is now just as familiar as the processes, so that our “old hands” formed a brisk quintet with the support of new sports spirits. The weather played along: the Tuesday afternoon was pleasantly summery, with fresh breezes but no rain, making running and picnics as usual fun. As an innovation this year, there were small medals that can be assembled into a pentych — a nice addition to MediaCC's growing small trophy collection. 👍

What's new in 2025 on the topic of “application observations”?

On the pages of an ethics committee, applicants have recently found the category “application monitoring” under the categorization of their clinical trial for some interventional randomized controlled clinical trials involving medical devices.

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This is new and applies to the Berlin Medical Association. Here, such studies that fall under §47 paragraph 3 MPDG - formerly §23b of the MPG - are referred to as: “Application monitoring in accordance with Section 47 paragraph 3 Medical Device Implementation Act (formerly §23b Medical Devices Act)”.

This is therefore contrary to the definition of the Working Group of Medical Ethics Commissions (AKEK), according to which: “Application observations are non-interventional studies in which the use of a medical device under everyday conditions is documented without the doctor being influenced by a predetermined test plan in his/her treatment decision. The decision to use the product is independent of participation in the study.”

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We are excited to see how this will unravel!

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MEDIACC ist neues Mitglied im BVMA

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Wir freuen uns, bekannt geben zu dürfen, dass MEDIACC ab sofort Mitglied im Bundesverband Medizinischer Auftragsinstitute e.V. (BVMA) ist.

Der BVMA ist die führende Interessenvertretung der in Deutschland ansässigen Contract Research Organisations (CROs) und steht seit über 30 Jahren für höchste Qualitätsstandards, Transparenz und Integrität in der klinischen Forschung. Voraussetzung für die Aufnahme ist die erfolgreiche Teilnahme an einem umfassenden Qualitätssicherungsprogramm, das die Einhaltung internationaler Standards wie ICH-GCP sicherstellt und regelmäßig durch unabhängige Audits überprüft wird.

Mit der Mitgliedschaft im BVMA unterstreicht MEDIACC den eigenen Anspruch, klinische Studien von Medizinprodukten auf höchstem Niveau und nach anerkannten Qualitätsstandards durchzuführen, neben der Zertifizierung seines Informationssicherheitsmanagementsystems. Gleichzeitig profitieren wir vom intensiven fachlichen Austausch im Netzwerk, aktuellen Informationen aus Gesetzgebung und Behörden sowie exklusiven Fort- und Weiterbildungsangeboten für unsere optimal durchgeführten Studien.

Wir freuen uns auf die Zusammenarbeit mit den anderen Mitgliedsunternehmen und darauf, die Zukunft der klinischen Forschung in Deutschland gemeinsam aktiv mitzugestalten.