Not new is the realisation that many published research results are wrong or even negligently falsified. “Flexibility” in the analysis and presentation of the collected data allows for a wide range of interpretations. The tendency to do so is due to the fact that the incentive to do science is no longer the same as it used to be: without regular publications, the career ladder shakes, publishing is done out of necessity, not out of curiosity and joy. Not infrequently, even private differences of opinion, deadlocked views or the insistence on standpoints and expectations are behind the essays. All this leads to a flood of bloated articles in minor journals that do not advance science. Meaningful science requires better networking of experts from different disciplines, linking several levels of analysis and constantly questioning criteria. MEDIACC does its part and delivers clean, insightful scientific work.
Our NUB study, personally supervised by the G-BA, is gradually getting underway. One centre after the other is including patients and they are actively participating in the data collection. Great! Of course, such a study start is often a bit bumpy, but thanks to our many years of expertise, problems are quickly identified and solved. Many thanks to the G-BA for the good cooperation! Our customer, the sponsor, also shows us deep trust, for which we will, as always, return the favour with excellent work. Trust is never disappointed with us! Thus, we are looking forward to the further study inclusions and are curious to see how things will continue.
A few days ago, on 5 June, was World Environment Day. Few of you will have noticed this, as the world is currently taking care of other, supposedly more urgent problems. But what could be more important than the future of our descendants who will inhabit this world? Even in the face of the crisis, we must not lose sight of keeping our environment healthy. This is why MEDIACC is today participating in a project against climate change and for the reduction of our CO2 footprint, and it is literally “hands on” – together with a well-known environmental movement of young people.
As soon as the G-BA gives the last green light, our big NUB study will finally get underway. We can’t wait to get started and we’re champing at the bit! This multicentric, randomised, double-blind study on a promising innovative medical device will be great fun for all involved. Ready for take-off?
In COVID-19 times, clinical trials are much more difficult to manage: Some trial centres are no longer available, on-site monitoring is reduced to the bare minimum, visits have to be cancelled or postponed, often even recruitment stops. The start of new studies that are not aimed at the prevention or control of COVID-19 is sometimes delayed indefinitely. How do you deal with this? With appropriate Urgent Safety Measures (USM) and good fine-tuning between sponsor, trial centres and all other parties involved. The rights and health of the trial subjects take priority over all other concerns. We at MEDIACC take care of this: With a certificate from TÜV Rheinland, our employees are well prepared for the changed situation and are able to solve problems flexibly.
... the praised and feared MDR 2017/745 and the Medical Devices EU Adaptation Act-MPEUAnpG of 28.04.2020, which was passed in Germany. Most of our customers have already made the necessary changes. We at MEDIACC have already included the requirements for clinical studies according to the MPEUAnpG, apart from the increased administrative effort, in order to fulfil our mission: to simplify the market entry for medical innovations and increase patient safety! Clinical trials made in Germany!
Regardless of the ban on contact, we currently have one daily visitor to the MEDIACC office. Dachshund Ken keeps strictly to our office hours, but he does not think much of social distancing. Fortunately, he is not a transmitter, so we can safely exchange caresses with him. In times of contact prohibition and no-touch-policy, there is hardly anything more pleasant for us than to scratch Ken’s back or to watch him slumbering stretched out in the sun. We will probably not sizzle in the warm rays this summer on beaches on sun beds (which we have reserved with towels), but we should grant it to those who can. Right now, animals give us back a lot of what we miss. We are happy to have our permanent guest with us for a while.
... and we’re part of it! Recently another MEDIACC doctoral candidate passed her final examination and is now allowed to help her patients as a Dr. med. We are very proud of you and wish you all the best for the future!
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