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Hi, my name is Jimmy Shangala.I am a pharmacist with the Kenya Medical Research Institute at Kilifi.I have been in this post for close to 3 years.In that time I have supported at least 6 clinical trials.I am interested in meeting other pharmacists and pharmaceutical professionals who are involved in clinical trials.I would like to know about your sites ,your experiences and your scope of involvement in clinical research generally and clinical trials in particular.I am also looking forward to interacting with pharmaceutical colleagues who play non-traditional roles in clinical trials.
Thanks.
Jimmy Shangala,RPh, Kenya-East Africa.
 
 
 
 
 
 

  • jshangala Jimmy Shangala RPh 27 Jul 2012

    I agree with you Liz.Clinical research pharmacy in the traditional sense tends to be rather narrow.My biggest
    concern is that unlike other professionals who develop their CR skills through structured mentorships and on-job training, we lack focussed skill-based courses for pharmacists.What are the bench marks that I could use to evaluate my current performance as a research pharmacist?.Advanced training in pharmaceutics should be part of the training needs of all trial pharmacists.

  • eallen Elizabeth Allen - Regional Faculty Lead 26 Jul 2012

    Thanks Jimmy. I am sure the training initiatives are being developed in the other regions too, though ultimately we should share what we have all developed so as not to reinvent any wheels.
    Your post got me thinking more.... We are bouncing around ideas of topics for local workshops/seminars and have a little list on the go - to my shame pharmacy wasn't on it! However, dedicated pharmacy-related clinical trials training is probably very under-represented generally, the practical issues rather than the GCP guideline content. Maybe describing on your blog various clinical trial pharmacy-related challenges and how we ultimately worked through them could be useful, perhaps leading to the development of common training materials based around such cases? e.g. we are about to start a complex phase 1 interaction/dose escalation trial shortly where the IP formulation characteristics make the whole pharmacy side really complex to achieve. L

  • jshangala Jimmy Shangala RPh 26 Jul 2012

    Hi Liz,
    Thank you for visiting this blog.
    Feel free to network with other pharmacists on the forum.
    And please invite other pharmacists working as CRA's to join us.
    I like the idea of regional training initiatives.I hope that one day you will extend to the rest of the continent.
    Jimmy,Kenya.

  • eallen Elizabeth Allen - Regional Faculty Lead 26 Jul 2012

    Hello to you all from another pharmacist! I too work in non-commercial/public health clinical research. After leaving retail I worked in commercial clinical trials (pharma and CRO) as a clinical research associate. Where I am now, at the Division of Clinical Pharmacology, University of Cape Town, pharmacists work in a variety of roles (medical information, regulatory, clinical trials management and related research - the latter including pharmacometrics and clinical trials methodology). I think it will be great to have this forum to network, share experiences and ideas so thank you Jimmy. Those of you in Southern Africa can also keep an eye on our plans to develop the Southern African GHT Faculty (see other thread). It's in its infancy but we hope to pull together Southern African resources, conduct short workshops/seminars etc on relevant topics. There is no reason at all why pharmacists shouldn't play a role in this (as in the other regional faculties) - let's have some ideas!! Liz Allen

  • jshangala Jimmy Shangala RPh 23 Jul 2012

    Hi Tony,
    Feel at home.
    Invite the other pharmacist to join this forum.Also feel free to connect with the other contributors on the blog.
    The purpose of the blog is to allow contributors to interact and share their professional experiences as pharmacists in clinical research/trials.
    Jimmy.

  • tsang Tony Sang 23 Jul 2012

    Hi Everyone,

    I'm really exited about this forum.

    I'm Tony working with KEMRI/CDC in Kisumu Kenya. I've mainly been in vaccine research, Initially the Rota-virus vaccine and currently two Malaria vaccine trials. I also support other studies in our institution. We are two pharmacists here.

    Tony

  • jshangala Jimmy Shangala RPh 19 Jul 2012

    Hi Rafaella,
    I am pleased to welcome you to this community.You have actually started the discussion- you have just broken the ice.
    I am very happy with the focus on pharmacy- we need more pharmacy-related or pharmacist-driven research.This will increase our visibility as a profession.
    Jimmy, Kilifi Kenya.

  • rravinetto Raffaella Ravinetto 18 Jul 2012

    Dear Jimmy and All,

    I am also a pharmacist working in the field of non-commercial clinical research (as head of the Clinical Trials Unit at the Antwerp Tropical Institute).

    I fully agree with you that pharmacists may bring an important contribution to clinical and epidemiological research, both within and beyond the pharmacy. Within the pharmacy, they can among others play a key role for improving patients' adherence and compliance, and for improving the dialogue and the trust between the patients and the research team. Beyond the pharmacy, they may be excellent sites' coordinators, and I suggest that they could be involved in reciprocal monitoring schemes, and contribute to GCP/GCLP monitoring and quality supervision at their own sites as well as at partner sites.

    Hope this discussion will continue!

    Raffaella

  • jshangala Jimmy Shangala RPh 18 Jul 2012

    Hi Tanuja,
    Very glad to hear from you.That must be a really big site.I hope you will soon be mentoring alot of colleagues on this forum.I will visit the website and get back to you.

    Jimmy,Kilifi,Kenya.

  • gengiaht1 Tanuja N Gengiah 18 Jul 2012

    Dear Colleagues

    I'm the Head of Pharmacy at CAPRISA (www.CAPRISA.org) in Durban, South Africa. Always a pleasure to meet fellow research pharmacists from all over the globe.

    I have over 9 years experience in the clinical trial arena. My role ranges from protocol development, to dispensing (I substitute when my team is on leave) to data analysis and publishing. I have postgrad training in Clinical Pharmacology and Epidemiology. Currently I'm trying desparately to complete my PhD in-between everything else. CAPRISA has 6 other pharmacists and 2 of them are in Co-Principal investigator positions - there's a non-traditional role for you Jimmy...

    Look forward to fruitful interactions on this blog.

  • jshangala Jimmy Shangala RPh 17 Jul 2012

    My most memorable experiences as a Clinical Trials Pharmacist was in the Ariel Study sponsored by J&J.This was an efficacy trial of Darunavir in children.we were one of the largest sites with 6 children.In this trial I experienced the whole thing from CROs,audits ,inspections,contracts,clinphone. I got to actually dispense meds to patients(something I rarely do in research), monitor/quantify adherence (by weighing bottles), assess drug palatability,etc.I also saw prescriptions being drawn on the basis of viral sensitivity genotype profiles.It was an important entry point into clinical research and I got to see the project from inception to site close out.the project involved collaborating with the local Government Hospital for the supply of the other ARVs.I also had to make frequent applications for import permits (Ritonavir would arrive with a shelf life of just about 2-3 months). The most important thing is that the intervention actually had a positive impact in children who were failing first-line therapy.

  • jshangala Jimmy Shangala RPh 17 Jul 2012

    Thank you Charles and Nguyen, we all have alot in common.Please invite others to join.Nguyen ,does it mean that the Oxford Reserach Unit in Viet Nam (I never knew that they were two words) runs independently?I have to ask you this because Charles and I work for a public institution that collaborates with Oxford through the Wellcome Trust.

  • nguyenntt Nguyen Nguyen Thi Thao 17 Jul 2012

    Hello,

    My name is Nguyen, I'm a Pharmacist Administrator at Oxford University Clinical Research Unit in Viet Nam. I hope to have a chance to learn a lot of things from all of you.
    All The Best

    Nguyen

  • charlesopondo Charles Opondo 17 Jul 2012

    Hi,

    I'm Charles Opondo, a pharmacist and statistician with the Child and Newborn Health Group within the KEMRI-Wellcome Trust Research Programme in Nairobi. I have been here for 5 years supporting a large cluster-randomised trial to improve care for hospitalised Kenyan children. I'm currently in my second year of a research degree in which I'm developing quality of care measures for paediatric hospital care.

    Regards,

    Charles.