How Germany’s Standard of Care and Local Legislation Influences Clinical Trial Participation
In the evolving landscape of clinical research, the standard of care is a critical factor influencing the success of trials. Martin Krauss , CEO of FGK Clinical Research and president of the German Association of Clinical Research Organizations, in a chat with Maya Zlatanova, CEO of TrialHub, discussed how Germany's high standard of care has shaped the country’s approach to clinical trials and influenced global perceptions.
Over the past few years, the clinical research industry has faced significant challenges, including a dramatic 50% decline in private venture biotechnology investments between 2021 and 2023. This downturn has increased pressure on all stakeholders, particularly within the Contract Research Organization (CRO) sector. Amidst these challenges, the high standard of care in Germany remains a complex factor.
Germany's High Standard of Care
Germany's standard of care ensures that patients receive some of the best treatments available worldwide. Access to the latest medical advancements, however, reduces their motivation to participate in clinical trials compared to countries with lower standards.
Despite the challenge of motivating patients to join clinical trials in a country with excellent healthcare, there are still significant benefits to participation in research. Clinical trials offer patients early access to cutting-edge treatments and more personalized care even as part of the control group. Spreading awareness around these benefits is crucial for increasing patients’ interest in research.
Strategic Importance for Pharmaceutical Companies
The high standard of care in Germany also influences the strategies of pharmaceutical companies. As Maya Zlatanova highlighted in our recent conversation on Trials with Maya Z, "Germany is always considered for clinical research not just because of the timelines for conducting research but also because of the reimbursement timelines and the budgets available to implement the newest treatments."
This makes Germany a prime location for clinical trials, despite the high standard of care reducing patient recruitment speed.
The Medical Research Act: A Game Changer
The introduction of the Medical Research Act will further enhance Germany's appeal. Set to be fully approved by September 27, 2023, this legislation aims to streamline processes and reduce the time required to initiate clinical trials. Binding investigator site contracts, for example, will drastically cut down the lengthy period (sometimes up to nine to twelve months) previously needed for contract negotiations. This change alone is expected to make Germany a more attractive destination for clinical trials.
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Raising Clinical Trial Awareness
While the high standard of care poses challenges, it also underscores the importance of promoting the benefits of clinical trial participation among the German population. Many patients are unaware of the advantages, such as better overall care and access to advanced treatments. As Maya suggested,
"We need to raise the awareness from patients to patients, people that have actually participated in trials... when you hear something from people that are like yourself, you generally trust them much better."
A Challenge and an Asset
In conclusion, the high standard of care in Germany is both a challenge and an asset in the realm of clinical research. By implementing strategic regulatory reforms and raising awareness of the benefits of trial participation, we can leverage this standard to drive significant advancements. Germany's Medical Research Act and the continued push for harmonization across Europe are steps in the right direction. By making clinical trials more efficient and accessible, we can ensure that medical research continues to benefit patients and society as a whole.
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P.S. Standard of Care is at the center of our work lately as we saw first-hand how better understanding and alignment with the local patient journey can turn things around for clinical trials' performance. If you are interested in how you can achieve that too, feel free to contact me or my team at TrialHub
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3 个月Maya Zlatanova Martin Krauss the high standard of care in Germany is, as nicely layed out, a critical component in clinical trial planning and conduct. Thank you for that! Some further cents into that equation: The differences to other countries introduce the challenge of variability for the endpoint analysis, we all know, but also raises the hurdle for a new drug extremely high and complex. Therefore, standardization of care, as far as possible, for a global trial, is sometimes pursued, or certain treatments excluded because of either/and PK and PD interactions. At the end, a pivotal trial for gaining approval will always be somewhat "artificial". Only RWE studies can address those questions appropriately, with their issues, biases and flaws considered as well - the issue of differences in SoC across countries and regions is sometimes even more difficult to control in RWE compared to RCT studies.
Let’s Bring Research Closer to Patients
3 个月The full conversation is here: https://trialswithmayaz.transistor.fm/episodes/how-germany-s-standard-of-care-influences-clinical-trial-participation-with-martin-krauss