Clinical trials design and effective publication

 

 

Non-interventional studies or observational or post-marketing studies (PMS) make valuable contributions to medical research and represent important tool for getting data on safety and efficacy of pharmaceutical products in real medical practice.

When performed at a high scientific, methodological and organisational level they can deliver valuable information helping prescribers in making decisions.

PMS supplement Controlled Randomized Clinical Trails (CRCT) which are performed within the frame of complex protocol with the patients not reflecting real life population.

Using CRCT results outside the hypotesis it was addressing may lead to misleadfing conclusions and inproper decisions. For exampe PMS revealed that cost-effectiveness of Cox-2 inhibitors evaluated with CRCT does not reflect accurately the real-life.

Despite the obvious value of observational studies, they where seriously critisized for weak control and misuse by pharma companies, leading to the biased results.

That is why in 2007 new standards for observational studies whre adopted in US and Europe. This is “Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)” guidelines, similar to CONSORT for controlled trials.

The aim of quality assurance is to, meaning to avoid possible bias of results Introduction of these standards allows to design comparative observational studies and make valid, scientific statements based on the study results.

To achieve results, modifying prescribers’ behavior, we implement an appropriate study design and adequate data analysis, assure completeness and validity of the data and identify and resolve deficiencies at an early stage.

We will help you to raise the scientific level of your observational studies, obtain and publish influential results and get the maximum return on your investments.

 

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