Challenges in Academic Clinical Research – An Interview with Prof. Dr. med. Christoph Schindler
Academic clinical research is indispensable for a medical field focused on the well-being of patients. However, it faces structural challenges that are making it increasingly difficult to carry out. The lack of a stable regulatory framework hinders the efficient conduct of complex studies. Regulatory requirements, limited resources, and underfunded infrastructure are among the key obstacles. Prof. Dr. med. Christoph Schindler, Director of the Center for Clinical Research (ZKS) at Hannover Medical School (MHH), analyzes these challenges from an academic perspective and outlines potential solutions for a necessary shift in thinking.
Prof. Schindler, is academic clinical research in Germany currently overshadowed by industrial research?
In Germany, academic clinical research is systemically important but structurally disadvantaged. It addresses issues that are crucial for healthcare delivery, clinical guidelines, comparative therapies, vulnerable groups, and noncommercial innovation. However, it is precisely this type of research that suffers from fragmented funding, a heavy regulatory burden, and infrastructure that lacks sustainable funding. It is overshadowed by industrial research not because of a lack of relevance, but because of weaker framework conditions. Industry, on the other hand, has clearly defined business models, a professional research infrastructure, and high political visibility. In short: Academic clinical research is hampered by a mismatch between its societal benefits and the institutional support it receives.
If all academic programs were to disappear tomorrow: What, specifically, would be missing?
Academic studies are indispensable. They address highly relevant healthcare questions for which there is often no viable market incentive. This is precisely the aim of Investigator-Initiated Trials (IITs)—that is, studies initiated by a researcher. Their goal is to advance knowledge. Without academic clinical research, not only would “yet another segment of research” be missing, but so would the independent part of the system—the part that closes gaps in the evidence, compares standard therapies, further develops off-label options, and improves care under real-world conditions. Medicine would lose its autonomous clinical intelligence.
What specific roles do KKS and ZKS play in the day-to-day conduct of clinical trials?
KKS/ZKS transform a clinical idea into a GCP-compliant, fundable, and operationally feasible study project. They are far more than just service units in day-to-day study operations. KKS/ZKS serve as the academic “operational platform” for clinical research. They ensure that studies are not only medically sound but also regulatory compliant, operationally manageable, and scientifically robust. Research organizations support trials from design, budgeting, and grant applications through monitoring, data management, and drug safety all the way to analysis, the Clinical Trial Report, and publication. Without these established structures, many IITs would fail to overcome the practical hurdles that lie between the scientific research question and the actual conduct of the trial.
What are currently the biggest obstacles to academic clinical research?
The greatest limitations can currently be attributed to several structural shortcomings. First, the infrastructure is chronically underfunded. This is further exacerbated by the lack of reliable, long-term funding models. This uncertainty has a direct impact on research staff: there is a shortage of qualified professionals. It is difficult to retain staff who are already trained under project-based conditions that offer comparatively low pay. In addition, the existing funding framework for modern research is too inflexible.
Operational processes also continue to pose an obstacle: contract negotiations in Germany still take too long. The standard contract clauses set to take effect at the end of 2025 are intended to speed up processes, but they do not apply to academic, non-commercial studies. Despite extensive digitization programs, a functional bridge to the clinical trial infrastructure is still lacking. Furthermore, the culture of trial participation is not sufficiently established in Germany. And last but not least, the high level of regulatory and operational complexity slows down day-to-day trial operations.
Take “structural financial deprivation,” for example. Where is this most evident in everyday life?
Insufficient structural funding is evident in day-to-day operations. There are too few permanent staff members because funding for the studies is project-based. Among other things, this makes it difficult to establish stable career paths for study coordinators. Budgets are calculated too rigidly. Even normal delays, recruitment problems, or design adjustments put academic studies under financial pressure, since funding must be allocated in advance based on durations, milestones, and spending plans. Many processes are still carried out manually because hospital digitization and study infrastructure do not integrate seamlessly—for example, in patient screening, feasibility assessments, and certain areas of study documentation. Furthermore, the startup processes are too slow. Centers must constantly compensate for this despite a lack of funding.
What might sustainable infrastructure financing look like?
To put it simply: A study may be funded on a project-by-project basis—but the capacity to conduct studies in Germany must not be. Academic clinical research should be funded structurally, not just on a project-by-project basis. Sustainable infrastructure funding means: long-term base funding for study centers, separate funding for infrastructure and support costs, and supplemental project funding for individual studies. A federal-state framework also requires clear quality objectives: not “more money somewhere,” but a fundamentally different funding model.
What specific measures are needed at the policy-making level to strengthen academic clinical research in Germany in the long term?
Germany is reforming its higher education system. So far, however, academic clinical research has benefited only to a limited extent. To realize its full potential, IITs must be systematically integrated into the planning process, and clinical research centers must be funded as high-performance research infrastructures. This is a key lever that we will continue to pursue consistently.