Replies to post #423670 on Amarin Corp Plc (AMRN)

[Jasbg]

Snd101, Everyone can guess who is behind this post (Whala) - first post from new member 👎️

[Whalatane]

Snd. We need meaningful reimbursement in Germany , France and Italy . If I was the Ceo of AMRN I would try to engage those Health Depts in discussions on designing a clinical trial that if successful would make them commit to at least cover the selected population studied in the trial .

An obvious R-IT subgroup IMHO is the revascularisation subgroup . Event lines separated fairly early
Theres no placebo . We would compare existing SOC ( standard of care ) with SOC plus Vascepa and look at the revasc rates following the initial PCI procedure
In R-IT , these revasc rates were cut by roughly 50% ........so a major savings in healthcare costs to these Health Depts .
Again ...we need the buy in from these 3 health depts in at least designing , organizing and if necessary running this trial ...say as Kaiser ran MITIGATE. here in the US.

The trial has to be large enough ( properly powered ) so that these Health Depts agree will act on the results if the risk reduction is clinically relevant and statistically significant. The Greek trial Capt referred to is " hypothesis generating " .

Its important to understand how clinical trials are powered to get health depts to act on the results
Power is critical in clinical trials because it helps determine the ability of a study to detect a true effect if it exists. In other words, it measures the likelihood that the study will correctly identify a treatment effect when one truly exists, as opposed to mistakenly concluding that there is no effect (a false negative) or incorrectly concluding that there is an effect when there isn't (a false positive). Here are a few key points about the importance of power in clinical trials:

Statistical Significance: Power is closely related to statistical significance. A study with low power may not detect a true effect, even if one exists, leading to a false conclusion that the treatment is not effective. On the other hand, a study with sufficient power has a better chance of detecting a true effect if it's present.

Sample Size Determination: Power analysis is used in the design phase of a study to calculate the sample size needed to achieve a desired level of power. This calculation considers factors such as the expected effect size, variability of the data, and the desired level of statistical significance.

Ethical Considerations: Conducting a study with low power can be considered unethical because it may involve exposing participants to potential risks without the ability to generate meaningful results. Adequate power ensures that the study has a reasonable chance of answering its research question.

Resource Utilization: Clinical trials are resource-intensive, involving time, money, and human resources. Conducting underpowered studies can be a waste of these resources, as they may not provide reliable answers or contribute significantly to scientific knowledge.

Regulatory Approval: Regulatory agencies often require studies to have adequate power to detect clinically meaningful effects. This requirement ensures that the evidence generated from trials is robust and can support decisions regarding the safety and efficacy of interventions.
In summary, power is crucial in clinical trials because it influences the reliability and validity of study results, ethical considerations, resource utilization, and regulatory acceptance. A well-powered study is more likely to provide meaningful insights and contribute to evidence-based decision-making in healthcare.

Bottom line ...Ypu need these EU health depts to buy into this trial in some form ( AMRN may fund it but the Health depts have input on design and actually run the trial ........short trial ...max 3 yrs if possible and if properly powered )

Kiwi

[Whalatane]

Snd. Here's an example of a clinical trial actually run by the German Health Dept

Short trial. ... 1 year
https://pubmed.ncbi.nlm.nih.gov/31475799/

Conclusions: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.)

MI and stroke significantly lower but no increase in major bleeding .......run a similar trial with Vazkepa

Kiwi