STUDY SUPPORT

Camovis creates new framework conditions and know-how for successful clinical trials.

 

The cartons with the study materials are stacked up to the ceiling. In between there is medical equipment, things for which there was no space in the practice, a few cleaning agents. Wherever there was space left in the small room, there was something standing around … “Zack, boom, bang” was the cue for the Camovis-Nurses with a call for help from the CRO in a long-established practice in Berlin. And yet first of all, it was time to clean up – literally. Both structurally and communicationally.

“We can no longer reach the doctor”, was the sparce information given by the Clinical Research Organisation, which turned to Camovis for support. A gastroenterological study had been placed in the practice and was now about to be initiated. But: literally neither picture nor sound followed the attempts of the CRO to establish contact in order to initiate all necessary procedures.

To the surprise of everyone involved, the doctor spontaneously contacted Camovis and arranged an initial consultation with the Flying Study Nurse.
Once a week, always Tuesdays, eight patients – and no room – were the general conditions that the doctor set for the Camovis employee. Actually, only one of his colleagues was to be trained, who was to supervise the study in addition to her daily work in the practice: regularly determine vital parameters in the patients, register medications, record and process the data.

In everyday life and against the background of scarce staffing levels, this was a less than practical solution. Especially not from the time when a second study was initiated in the same practice. 13 patients simultaneously, screening and analysis. An “it’s not too much effort” as a reaction after the seven-hour initiation by the monitor.

For the Camovis team o deployment was like any other. In addition to the “normal” requirements of the study, the Flying Study Nurse acted as a communicative problem solver at all levels. A physician who was not very accessible at the beginning. Little time and even less understanding for the framework conditions that such a study requires, a structure “in which there is actually no room for oneself”, and of course other projects that also required all attention – a balancing act between professional commitment and personal psychological stress limit for the nurse.

In the morning, shortly before seven, in an office in Berlin: patient couch instead of desk, laboratory or infusion room instead of patient room. If the cramped situation in the practice made it necessary, the Camovis employee also looked after the study participants at their workplaces. Take a deep breath and consider alternatives, always stay friendly and still assert yourself: The patients should notice as little as possible of the fact that it was lacking in the structure.

“It can’t be done alone” the Camovis team knows from experience. As in Berlin, the practice team must always be involved so that a study can be carried out comprehensively and in accordance with the protocol. Here, for example, temperature logs had to be kept daily and samples had to be moved regularly. “This meant motivating, breaking up fronts and creating communication again and again.” The Flying Study Nurse then even took out the garbage herself once in order to prepare the visit by the monitor.

The Camovis Nurse had to prove themselves in many conversations with the doctor and even more diligence in order to gain the necessary freedom step by step – even if she sometimes doubted that everything would work. The sponsor uses the new communication basis to ask the physician questions about the study. They can deal with him; they complement the employee. After 9 months, she now works up to three times a week in the practice. Further projects at the request of the doctor follow: “I now know that I need you …”.