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Challenges of Establishing
and Monitoring a GCP Trial
in Remote Settings
By the Performance and Monitoring Unit (PMU) Team, Swiss Tropical Institute
Working in rural areas such as the NECT trial sites in Dipumba and Katanda in the Democratic Republic of the Congo (DRC), researchers face many challenges that do not exist in other settings. Thus, the practical difficulties in running a trial to Good Clinical Practice (GCP) standards should not be ignored. These challenges include poor infrastructure and supply, a lack of well-educated health personnel, lack of standard operating procedures, and difficulties in accessibility and in assuring security. Here, we describe the main challenges of the establishment and monitoring of the NECT trial according to GCP requirements in the DRC. 
The sites were installed, prepared, and supervised with the support of many involved partners (STI, DNDi , Epicentre, PNLTHA, and ITM). DNDi refurbished and equipped two NECT sites to improve standards for adequate diagnosis, treatment, and care of the patients and to ensure the investigators the rigorous documentation, follow-up of the patients, and communication to the outside world. STI’s activities comprised of the installation of trial-specific laboratory and diagnostic equipment, training of staff, coordination, implementation, and monitoring of the NECT study. Prior to and during the NECT trial, all staff received extensive on-site training.
Differences in concepts and cultures of why and how things should or should not be done were challenges that had to be overcome. In general, no systems were in place to document the work, patient-specific information, or other issues; a culture of documentation and communication was only marginally existent. Clinical trial concepts and resulting activities such as informed consent, drug accountability, storage conditions (temperature, locker), quality control (i.e. diagnosis confirmation), and filling out forms were new to the teams and hence a continuous challenge.
A difficult but critical issue was the concept of adverse events (AE) and reporting of serious adverse events (SAE). In order to have reliable and well-monitored communications of safety issues, the difference between severeness (a clinical term) and seriousness (a technical & legal term) had to be understood and consistently conveyed. With heat, humidity, and a rather precarious room and furniture situation, practical solutions had to be found for the protection, storage, quality, and accountability of the investigational medicines and associated materials. Not to mention the study and patient records as well!
Constant contact, including frequent site visits, with the teams was essential for the adequate conduct of NECT and for the maintenance of a coherent technical standard. Providing feedback clearly motivated them! The teams of both sites, Dipumba and Katanda, recognised the monitoring visits not as threats but rather a key support.
The continuous learning process for both sides, the monitors, and the trial site teams is the key to the success of the NECT programme and its GCP compliant conduct.
Congratulations to the teams in DRC, in Dipumba and Katanda!
The sites were installed, prepared, and supervised with the support of many involved partners (STI, DNDi , Epicentre, PNLTHA, and ITM). DNDi refurbished and equipped two NECT sites to improve standards for adequate diagnosis, treatment, and care of the patients and to ensure the investigators the rigorous documentation, follow-up of the patients, and communication to the outside world. STI’s activities comprised of the installation of trial-specific laboratory and diagnostic equipment, training of staff, coordination, implementation, and monitoring of the NECT study. Prior to and during the NECT trial, all staff received extensive on-site training.
Differences in concepts and cultures of why and how things should or should not be done were challenges that had to be overcome. In general, no systems were in place to document the work, patient-specific information, or other issues; a culture of documentation and communication was only marginally existent. Clinical trial concepts and resulting activities such as informed consent, drug accountability, storage conditions (temperature, locker), quality control (i.e. diagnosis confirmation), and filling out forms were new to the teams and hence a continuous challenge.
A difficult but critical issue was the concept of adverse events (AE) and reporting of serious adverse events (SAE). In order to have reliable and well-monitored communications of safety issues, the difference between severeness (a clinical term) and seriousness (a technical & legal term) had to be understood and consistently conveyed. With heat, humidity, and a rather precarious room and furniture situation, practical solutions had to be found for the protection, storage, quality, and accountability of the investigational medicines and associated materials. Not to mention the study and patient records as well!
Constant contact, including frequent site visits, with the teams was essential for the adequate conduct of NECT and for the maintenance of a coherent technical standard. Providing feedback clearly motivated them! The teams of both sites, Dipumba and Katanda, recognised the monitoring visits not as threats but rather a key support.
The continuous learning process for both sides, the monitors, and the trial site teams is the key to the success of the NECT programme and its GCP compliant conduct.
Congratulations to the teams in DRC, in Dipumba and Katanda!
Published by Drugs for Neglected Diseases Initiative - 15 Chemin Louis-Dunant 1202 Geneva Switzerland - Photo credits: DNDi unless otherwise stated - Editor: Sadia Kaenzig - Tel: +41 22 906 9230 - Fax: +41 22 906 9231 - www.DNDi.org