Quote: With respect to clinical trials, the German government views studies as an important part of providing high-quality medical care to its citizens.4 As part of the European Union (EU), clinical trial approval processes in Germany are standardized, reliable, transparent, and allow for relatively short study start-up timelines.
Quote: The pharmaceutical industry often collaborates with universities (e.g., Bayer-Schering Pharma with the University of Cologne) and is a major source of support for investigator-initiated trials. Overall, pharmaceutical companies fund 70% of all clinical trials performed in Germany.5 Industry associations, including the Association of Research-Based Pharmaceutical Companies (vfa), the German Pharmaceutical Industry Association (BPI), and the Federal Association of the Pharmaceutical Manufacturers (BAH), are closely involved in discussions with the government regarding laws, regulations, and guidelines.
It seems it is quite common for many clinical trials in Germany to be initiated and sponsored by academic researchers. Called IDCTs, these investigator-driven clinical trials are quite prevalent.
See page 2 - Executive Summary
Quote: Typical examples are proof of concept studies, studies on orphan diseases, comparison of diagnostic or therapeutic interventions, surgical therapies or novel indications for registered drugs. IDCT thus have a much broader scope and potential impact than industry-driven clinical trials. IDCTs form a key part of patient-oriented clinical research, and create the basis for continually improving patient care.
Interestingly, the German University PR used the word "novel" to describe the approach for this particular P2 trial. Quote: This Phase II trial involves a novel approach combining a broad spectrum, fully personalized vaccination strategy with a targeted immune system checkpoint inhibitor in colorectal carcinoma.
Now if you look at that summary statement, it indicates that usually trials for novel indications use registered drugs. So is DCVax-L registered already? Or just about to be registered? A quick look on this link shows it doesn't seem to be registered yet, unless I'm missing something (which often happens). http://ec.europa.eu/health/documents/community-register/html/alforphreg.htm
Quote: Now apparently, in the US, an investigational agent may NOT be administered to patients for research UNLESS an investigational new drug application (IND) has been submitted to the US FDA. However, there are InD exemptions for studies of lawfully marketed drug or biologication products for the treatment of cancer.
Huh. Okay, I did not know that. Maybe an Investigator-initiated trial is different than an Investigator-driven trial. They kinda sound the same but maybe they're not?
Or... maybe they are the same thing, but this FDA rule doesn't apply to investigator-initiated trials in the EU.
Quote: IIT clinical trial agreements (CTAs) are different from CTAs for industry-sponsored trials for three main reasons: ? The company does not have the sponsor’s regulatory responsibilities. ? The investigator is asking for help from the company, instead of the other way around. ? The test article is usually a marketed product (as in Phase IV studies).
and there's this passage in there...
Quote: Although a pharmaceutical or other company may not sponsor a clinical trial from the regulatory perspective, it can provide support to the sponsor-investigator in the form of test articles, grants, services and advice. Although the investigator’s objectives may be purely scientific, a pharmaceutical or other company might find the study worthy of support. The study might, for example: ? Explore use of a marketed drug for new indications, in new populations, in new dosage regimes, or in new combinations with other treatments. ? Evaluate biomarkers that could be useful in diagnostic tests or treatment management. ? Refine safety and effectiveness information. ? Foster scientific exchange and collaboration. ? Demonstrate the company’s willingness to expose its marketing claims to third-party research.
But the wording did seem a bit odd in the German University press release. It says they must complete certain preparatory activities, including obtaining regulatory approvals.
Quote: After completing certain preparatory activities, including obtaining regulatory approvals, the Phase II trial will treat patients for up to 6 months with DCVax®-L and the checkpoint inhibitor Pembrolizumab, followed by long-term follow-up.
Do you think that instead of "obtaining regulatory approvals", they instead meant "obtaining regulatory authorization" to move forward on the trial?
Weird. Well, maybe there's something in this post that will help you to feel better.
