Let me introduce myself first: I am Angela Colbers, working as a research assistant and post-doc at the Department of Pharmacy of the Radboud University Medical Center (in Nijmegen, the Netherlands). One of my various tasks is monitoring of clinical trials. I do this internally for several studies for which we are the sponsor. For DolPHIN 2 I am appointed as external monitor by the University of Liverpool. Here, I would like to explain a little about the purpose and importance of monitoring when conducting a clinical trial, and about my approach to monitoring of the DolPHIN 2 trial in particular.
What is the purpose of monitoring in a clinical trial?
Monitoring has been implemented for the protection of human subjects (the participants within a clinical trial) and to ensure that studies are conducted to high standards of quality. This is important for the safety of participants in the study, for the quality of the study itself, but also for the “general population”. For example, when a new drug comes on the market, it is important that the underlying studies have been performed in accordance with Good Clinical Practice (GCP) and regulations and generated high quality, valid data.
How is this achieved?
The monitor has to assure the competence of the study team, assure the suitability of the facilities, check the availability of the essential documents, verify whether the included patients met the in- and exclusion criteria, whether the protocol is adhered to and also whether the data in the database match with the data collected by the site.
About me and and my approach to monitoring the DolPHIN 2 trial
I have been working in the field of clinical trials with medicines since 1995, mainly in the European setting. I am the project manager of an international network studying the pharmacokinetic behaviour of antiretroviral drugs in HIV-infected pregnant women in Europe (PANNA network). I did my PhD on this subject in 2015. Therefore, I think I can evaluate the conduct of the DolPHIN 2 trial both on a GCP, ethical and regulatory level, as well on a scientific level.
My approach is a supportive, collaborative one: I think that it is important as a monitor to assist the site in optimizing the conduct and quality of the study and the safety of the participants, rather than being a police officer.
Because I am not at the site during the entire DolPHIN 2 study, internal monitors will be doing most of the “field work”. They will be trained by me and counselled during (weekly) phone calls. I plan to visit the sites myself at least twice a year, but in the first year that will be more often, depending on inclusion rates. I certainly will come over very soon after inclusion of the first participant to tackle problems and to make sure that the protocol is adhered to and that everything is clear.
Because of the impressive DataFax system - a system we are using to manage, input and store data related the the trial - the trial database will be maintained in real time. I, as an external monitor, can log into the system and check for inconsistencies at home, at any time. That makes life a bit easier. Although I love to come over to the sites to work with the super teams at both locations!
Looking forward to work with the marvellous DolPHIN 2 teams on the project, collaborating in a constructive and open way to deliver the best care to the participants and to ensure the best treatment for future patients!