Clinical trials

55 coordinators and study nurses from the whole Czech Republic as well as representatives of the neighbouring Slovakia met in the historically first meeting held on 20 April 2012 in Brno.

Meeting of coordinators has confirmed interest in further cooperation.

55 coordinators and study nurses from the whole Czech Republic as well as representatives of the neighbouring Slovakia met in the historically first meeting held on 20 April 2012 in Brno. The event was organized by the Department of Clinical Studies of Masaryk Memorial Cancer Institute with the objective to establish mutual cooperation of coordinators, study nurses and data managers of the clinical studies.

The post of the coordinator of clinical studies has appeared in the Czech institutions only a few years ago and despite differences of the models in individual hospitals it became the integral part of each clinical study. But still it is a new profession which looks for its status and which must defend its prestige.
The Brno meeting has tried to address the issue of coordinators in two ways: at a more general level the participants discussed what models of coordination of the clinical studies were applied by institutions of different kind, practical questions concerned detailed determination of this profession, job description and its status among other members of the study team. The discussion pinpointed possibilities of further cooperation among the coordinators.

Methods of organization of clinical studies

Models of coordination of the clinical studies was presented in Brno by Bohumila Pavlasová on behalf of Masaryk Memorial Cancer Institute, Hana Kostková from the St. Ann’s University Hospital – ICRC and Zdeňka Ptáčková on behalf of the University Hospital in Hradec Králové. An interesting view from another side – on behalf of academic clinical studies – was presented by Marianna Brabencová from the Faculty of Medicine of Masaryk University included into the coordination network CZECHRIN (Czech Clinical Research Infrastructure Network).
Individual presentations and conclusions of the questionnaire research encompassing 15 hospitals confirmed variability of models of coordination of the clinical studies.
As stated by Renata Horová from Masaryk Memorial Cancer Institute, the rising number of institutions have a separate department focused on preparation, administrative support and overall organizational cooperation of the clinical studies, which is also possible at the level of large multidisciplinary institutions. Coordination of the therapeutic phase of clinical studies is much more complex and only few hospitals have allocated a separate department for it.

Role of the coordinator of clinical studies

What is the job description of the coordinator, study nurse or the data manager? The meeting in Brno and results of questionnaires have revealed that the definition itself of these posts (separate in many hospitals) deserves attention. From the results it follows that the coordinator takes care rather of administrative and organizational tasks, whilst the work with the patient, included into the clinical study, is performed by the study nurse. But there is one model, where the coordinator’s work includes all three aspects: organization, work with the patient and data loading.
Rough results of questionnaires from 15 hospitals can be found in the table below:

 
coordinator
physician
study nurse
investigator meeting
45%
86%
23%
kick-off/initiation meeting
77%
90%
63%
protocol
73%
95%
27%
therapy schedule
54%
73%
23%
medical staff education
50%
64%
9%
patient education
32%
91%
23%
screening
50%
82%
23%
randomization
41%
82%
9%
monitoring
64%
68%
27%
preparation for audit
64%
73%
13%
contact with patient
45%
91%
68%
measurement FF
13%
23%
73%
establishment AE
9%
91%
4%
grading AE
13%
82%
4%
concomitant medication
18%
91%
4%
report SAE
41%
86%
4%
biological material sampling
13%
4%
73%
biological material processing.
54%
14%
41%
preparation of medication
18%
27%
36%
administration of medication
4%
27%
59%
X-ray results
45%
27%
4%
record into CRF
41%
54%
4%
solution of queries
54%
50%
9%


Training course “Clinical Study Coordinator” and “GCP”


In the second part of the meeting Šárka Selvekerová from Masaryk Memorial Cancer Institute has familiarized participants with proposal of the accredited training course “Clinical Study Coordinator” that should run most probably from autumn 2012 with certification awarded by NCO NZO (National Centre of Nursing and Other Health Professions). The graduates will be given the certificate with the list of activities that can be performed separately, without a specialized supervision; i.e. in practice this training course can lead to increase of prestige of this profession as well as to adequate grading. A more detailed information can be found in the attached presentations; they will be mailed to the participants as soon as the term of the training course is known.
The coordinators should also pay attention to the training course of the Good Clinical Practice (GCP), organized within the scope of the PharmAround project by the Faculty of Medicine of Masaryk University on 19 May 2012. The training course is free and is certified by the State Institute for Drug Control. A more detailed information and registration forms can be found at the website www.pharmaround.cz.


Possibilities of further cooperation of the coordinators

Interest of some fifty coordinators and study nurses in a common meeting and its positive evaluation indicates that the future cooperation will be based on solid foundations. In conclusion of the meeting the following proposals of further cooperation were presented:

1. Creation of a section for the coordinators at the website www.pharmaround.cz, where the coordinators can fund useful information about education events, training courses, different information materials, references, etc. You can also find here all papers and presentations read in Brno. To download them in PDF, you must log in yourselves simply at the website. Possibility of a separate website in the future.
Discussion: content/scope of the website

2. Proposals for further forms of communication within a closed group enabling discussions, internal contact sharing, etc.; mail to michaela.hanakova@mou.cz.
Discussion: creation of a profession group on Facebook, closed e-mail forum, etc.

3. Training courses focused on different topics, e.g. GCP, RECIST, CTCAE, data management.
Discussion: monitoring of interest, topics, participants

4. Next meeting(s) of the coordinators: once a year - spring 2013
Discussion: organiser, concept and mission of the next meeting

The Brno meeting of clinical study coordinators was the first event of this kind, but it is quite evident that not the last one. We are looking forwards to the future events, training courses or through your ideas and discussions only.

All presentations can be found at the address http://www.pharmaround.cz/cz/klinicke-studie/materialy-z-akci-pro-koordinatory/.

Ideas and comments shall be emailed to: michaela.hanakova@mou.cz.

Michaela Hanáková
Department of Clinical Studies
Masaryk Memorial Cancer Institute

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