I was privileged to attend a combined GCP and Study Specific Training at the SMS guest house of Juaben governmental Hospital Ghana from 10th to the 12th of January 2011
The aim of this course was to relate the principles of ICH GCP to trial specific activities during the conduct of an upcoming trial and to ensure that study personnel can actually understand the Good Clinical Practices they will need to apply while executing trial related duties.
The Medical Research Center of Juaben Governmental Hospital is one of the two sites retained in Ghana by the MIP (Malaria in Pregnancy) consortium, to conduct a multicentre study going on within four (4) countries in Africa.
The aim of this study is to determine the safety and efficacy of three antimalarial drugs administered to pregnant women infected with Pf. malaria (in their second or third trimester), and to find out the outcome on mother and child.
GCP workshops are usually isolated from specificities of the sites where trials will be conducted and therefore not applicable on the field. The idea of the P.I in order to avoid this pitfall was to organize r a specific directed training for his entire team (25 members from the two sites comprising of study nurses, laboratory personnel, social workers, etc…).
In the same spirit, two local senior physicians trained and certified in GCP were invited to conduct a three days training program with the clear objective to transfer their experience and knowledge to the course participants
The calendar was organized around three main working sessions covered within three full working days.
- Overview of the study protocol
- Responsibilities of the study staff
- Overview of ICH GCP
- Presentation of GCP principles in relation to the study
- Emphasis on ICH GCP principle on AE (adverse events), SAE (Serious Adverse Events) and their reporting
- Informed Consent and source documentation
- Role play based on various case scenario developed by the facilitators (using study source documents) to bring out all aspects of the study and evaluate the understanding of the study team members on how best to handle them.
- Emphasis on ICH GCP principles on IB (Investigational Brochure)
- Simulation exercise with two willing pregnant women (invited from the Juaben Hospital antenatal clinic) to test the team understanding of recruitment procedures and samples taking
By the afternoon of the third day, the quantity of information assimilated by the study team and the quality of their responses during the simulation exercise was impressive:
- While questioned by the facilitators about two major concerns during the conduct of a trial, the team could respond without hesitation: Safety of subjects, and Credibility of data.
- The 2 pregnant women were interviewed separately by the recruitment team leaders from the two sites in their local language, and were convinced within 30-35 minutes, to participate to the study, sign the consent form and to have their finger pricked by the lab technicians for sample collection (using hemocue testing)
- The whole consenting/ sample collection procedure lasted for just one hour with facilitators ensuring that they apply GCP principles at every stage (collection of blood for filter papers, blood slides, hemoglobin test and RDT).
- In compliance with the study protocol, the mother whose RDT results were negative were informed of their results and given some relevant advice by the investigators on how to improve their food intake in order to maintain an adequate Hb level during pregnancy.
- The pregnant women were later on thanked for their participation, offered some refreshments, and informed by the study team that if willing they could always contact the study team during their next antenatal clinic to make sure they were still free from the disease.
III/ What should we retain from Juaben experience?
I conducted a short interview of the study P.I, the training facilitators and some team members after the training and these are their observations:
- Training facilitator 1 (an investigator in Juaben site): It was very tasking and demanded a lot of mental work to bring all the concept of GCP to the specificity of the study, and to conceive case scenario to bring out all aspects of the study, but it was worth it
- Training facilitator 2 (MD, in charge of ICH GCP overview): I believe this formula is more interesting than completing an -eGCP (online), as the knowledge from the e-GCP still needs to be translated and does t not take site study specificities into consideration. Moreover, they might not have a room for a role play, which provides fewer possibilities for the trainee to test his/her understanding of the course on the field. This was also a good opportunity for study personnel to take ownership of their trial with the ethical responsibility derived from ICH GCP course
Training participants: It was very helpful, and it enabled us to see the reality of the process described on papers. In addition our understanding of ICH GCP on the first day and the third day were two worlds apart.
- Lab technician: As much as it gave me a more practical exposure, I found GCP so applicable which it is better than just theory.
- Social worker (who participated to the pregnant woman interview): the simulation exercise taught me never to take an illiterate woman for granted. As I followed the principles of GCP I could interact more easily with potential subject and I was impressed with the concerns and quality of questions of the mother interviewed despite their inability to read the IC.
Study P.I: I prefer specific directed training compared to general workshop training. I believe that for a study to be successful, you must tailor the training to the site characteristics, which of course does not mean we should do away with the concept of GCP, but rather we should relate it to the trial for a better understanding and application. In addition, to be able to talk and communicate some issues like patient consenting, we should ideally have done this task before, in this manner we can easily translate the GCP concept to a simple language the field workers can understand. Finally, concerning the issue of e-GCP for certification purpose, I am of the opinion that though the paper is important for documentation (IRB requirement), what the trainee understood and will apply is what matter most. To achieve this, we need more trainers in the future. Sites should endeavor to train two or three senior staffs (MD, pharmacist, etc.) who will then be in charge of transferring their knowledge to the rest of the team. I suggest the setting up of a body, which can send an observer to see how we conduct our trainings in the sites and if satisfied they can give us the go ahead for accreditation for such exercise
TAKE HOME MESSAGE: The point of this article is not for mere literature, but to stimulate us to bring ideas together in order to build the future of clinical research according to our settings and specificities. So please have your say…..
Thank you so much! This is an excellent idea and excellent experience!
HI thank you for sharing your experiecnce. I agree with you on your las paragraph that training should be tailored to the specicific needs of the site, taking into account the challenges posed by ethical issues which arise from the community from which research is being conducted.
Study specicific training should be conducted to familiarize staff with key aspects of the protocol that might affect and influence implementation and should borrow from the experience of other studies that have been conducted in the same region to ensure that in the implementation of the protocol key aspects such as community uptake and norms and traditions that might influence retention and recruitment are taken into consideration.
GCP aspects can be ailored into these aspects to ensure a proper intergration, between protocol and GCP, or it can be included as an aspect i.e. a module into the study specific training.
It is imperative that study staff are clear about protocol guidelines and how aspects of implementation will occur, as their understanding influence the sucess of the study.