Clinical Research Workshop in Abuja, Nigeria

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• chidemannie 26 Feb 2012

  Wow! How am I glad to be part of this as a lad who believes in Bionics and biomedical engineering never had had this kind of opportunity here in Nigeria. I'm hopeful and looking forward to May 7, 2012. Thanks Glory, and all for this opportunity.

• Dr Ado Mohammed 23 Feb 2012

  Nice topics, Trudie, and very relevant too.

• Dr Ado Mohammed 23 Feb 2012

  To introduce myself, I am a consultant in Pharmaceutical Medicine and a CEO of Pharmedas Clinical, a new CRO and biopharmaceutical consultancy company in Nigeria with subsidiary outfits in UK and USA (www.pharmedascr.com).
  Great start. Please count on my support too. I am happy to take up a topic on product development or pharmacovigilance if a speaker in these areas is required.

• Trudie Lang 22 Feb 2012

  Hello Everyone. Firstly well done and congratulations on getting this far. Your workshop will be a huge success given the energy and enthusiasm that you are all showing.

  Can I make some suggestions and share what we have learnt holding similar workshops in other regions, with the intention of helping to guide you all in planning the programme?

  The novelty and value in these workshops are that they are cross-cutting so are for staff involved in all types of trials, all disease area and all roles of staff and researchers. As you have all found already just by meeting each other through Global Health Trials there are so many people working in clinical trials in Nigeria and they never normally have the opportunity to meet and share their skills and experiences. This is exactly why these workshops are so popular and impactful – most trial activities, steps, processes and challenges are exactly the same irrespective of the disease being studies. In fact it is a good ‘ice breaker’ to challenge the audience at the start the meeting to try and name something they came across in conducting a trial that was truly only applicable to that specific trial – do tell me if someone manages to come up with something, as this has not been achieved yet. At a recent meeting someone said ‘HIV sample handling’ in an ARV trial. It transpired the actual issue was tracking and labeling – generic for all trials!

  My point is that it was the cross-cutting knowledge sharing aspect that was the successful theme of other workshops. In Nairobi for example people who came to the workshops said they really appreciated being able to meet colleagues and realise just how many people in there are in Nairobi involved in trials. We had people from academia, government research programmes, CRO’s, NGO’s and industry. The programmes have been kept simple and worked well having a local expert speak on cross-cutting topics. How about this as a suggestion for the programme…

  1. Introduction to the workshop
  2. An overview of clinical trial capacity in Nigeria – who’s doing what
  3. Clinical trial regulation in Nigeria – steps, processes and future challenges
  4. Trial set up and operations – a rural and urban example perhaps (or academic and industry examples?)
  5. Clinical Trial Laboratories
  6. Clinical Trial Data Management – some examples maybe?
  7. Career development and Training to build a future of Nigerian Clinical Trialists
  8. Panel Discussion – building trial capacity in Nigeria

  This is similar to other workshop. Each talk was about 30 minutes with plenty of time for Q&A as they work well as very interactive workshops. The topics where highly transferable and the local speakers gave informative, locally applicable and high ‘guidance’ orientated talks.

  I hope that is some help – your meeting will be a great success and be a valuable meeting for all. Good luck and do let me know how we can help. Well done all!
  

  Attached files: GHT_DNDi_Workshop_Poster_19th_August_2011_Final.pdf
• Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead 22 Feb 2012

  Thank you Emmanuel for accepting to be a resource person. Hopefully, you will not have problem remembering May 7, 2012 because all intending participants and resource persons will register using the method that will be given by the editorial board. Materials for publicity shall also be made available. I will suggest that intending resource persons should indicate their interest early to help in planning. Comments made by John-Moses are well taken but because of the constraint of time, I am not sure of having a session for SQAN except if you want to present one of the topics already highlighted that is related to what you want to share and use the time to share the information.

• John-Moses Maduabuchi 22 Feb 2012

  Dear All,

  I have read your comments and suggestions, and also noted the date. Let me contribute along the line of the questions I asked before. I had read the Nairobi workshop programme and saw there was a co-sponsor with GHT for the event. My take is that what we are initiating for ourselves under this GHT forum is a project that will be sustained subsequently. So it is possible to get other corporate bodies to fund such workshops/activities in collaboration with GHT - apparently the time is too short to arrange this for this Abuja meeting. SQAN (our group) would be disposed in the future (if need be) to support such workshops. If it is accepted we could also inform other potential sponsors like the Pharma companies and CROs to support future events.

  For this event, we can get more experts to attend. But we all know ourselves and the current economic situation in Nigeria. For almost everybody you would invite (especially from outside Abuja), you would be expected to take care of the hotel accommodation and transport (flight or otherwise).

  I have seen that the hall has a 100-seater capacity; both experts in clinical research and inexperienced professionals would be expected in this meeting. I believe the one-day workshop will help us promote the activities of GHT and make a strong case for better collaboration in the promotion of clinical research in Nigeria. For the new guys, it will be a good opportunity to get them sensitized about the emerging Nigerian Clinical Trial industry.

  We are talking about a "Clinical Trials (CTs) workshop"; I mean to say that Clinical Research though synonymous with CT is also used in a broader sense. CT, a regulated research is just one part of human subject research, we are not intending to run a full CT training because this cannot be adequately completed even in 3 days.

  With respect to the issue raised by Emmanuel, the problem of HIV diagnosis (false positive or false negative issues)is a Quality Assurance matter, but it borders more on clinical practice than on CTs. Unless one wants to design a CT to address it. So is there any CT sponsor/investigator thinking about this? I could give him extra information on this, but one good thing we would achieve with this workshop is to make Nigerians understand the various available frameworks to address the myriads of Quality Assurance concerns which our people raise whenever Clinical Research is mentioned.

  Apart from individual presentations that may discuss QA in CTs, we ( in SQAN) will have a brief lecture on the QA of various fields (both regulated research, clinical practice and otherwise). This will help the audience appreciate how the QA profession as a whole can promote the CT industry in Nigeria. SQAN is the first professional society of QA Experts in Africa.

  Good Laboratory Practice (GLP), and Good Manufacturing Practice are not about CTs. The only connection is that before an investigative product (IP) is used for CT it ought to have been produced under GMP and tested under GLP.

  If the suggestion of "GLP" as I saw above, is because of the Clinical Lab involved in Clinical trials, the GxP will discuss is GCLP (Good Clinical Laboratory Practice).

  Varied Clinical Trial stakeholders, Bioethicists, Quality Assurance and other professionals shall be attending this meeting, so the idea should not just be to come and run a crash GCP or Bioethics workshop within several hours, but to sensitize people on the immediate need for more CTs in Nigeria and to brainstorm on how best we could collaborate in attracting more industry-sponsored CTs to Nigeria, especially with respect to sharing resources and networking Nigeria CT sites. We need to get this things happen here. Many people get disillusioned after attending a lot of workshops/seminars on CTs but with no opportunity participating in any.

  My belated response is not deliberate, please.

  Regards.
  

• AUGUSTINE ONYEAGHALA - Senior Contributor 22 Feb 2012

  Thanks my brother for the clarifications. Your points are well noted.I think I shall settle with overview of QA then. I only request that you keep reminding me about the date so that I can plan ahead and delegate responsibilities.
  I believe that we should not have problems with resource persons as the crop of clinical Research professionals on this forum have been tested and found to be excellent. So, do not be discouraged.Once again, thanks for your efforts.

• Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead 21 Feb 2012

  Thank you Augustine. I mean general overview of Quality Assurance because the topics are very wide and 1 hour is not enough to do justice to them. Also, we cant cover all relevant topics in a day workshop. That is why we cannot have another topic carved out. We may decide to forgo consent but there is a way the two may be combined and delivered within one hour. If the resource person interested in taking the IRB/IEC is not comfortable having informed consent with it then we can leave it out.The challenges of conducting clinical research in Nigeria is part of group discussion topics and not a presentation so you may just stay with Overview of Quality Assurance in Clinical Trials. I hope I am clear.Are there other researchers interested in handling the other topics?

• AUGUSTINE ONYEAGHALA - Senior Contributor 21 Feb 2012

  Thanks Glory for all your efforts so far. This current program looks better, but in my opinion IRB/IEC should be separated from informed consent since it may look too loaded for a single speaker to handle . Nonetheless, if more than one speaker is being planned to handle the topic , then it should be ok. On quality assurance, we should also be very specific for easy handling of the topic. What are we really interested in? GCP,GMP, GLP, GCLP quality assurance or general overview of quality assurance? Apart from these suggestions, I think the other topics are Ok.
  I should be available to handle challenges of conducting clinical research in Nigeria or any topic in quality assurance when clarified.
  Once again thank you for all your efforts and God bless.

• Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead 20 Feb 2012

  Thank you all for your useful contributions. I agree with the suggestions made by Augustine and Sani.The purpose of this discussion is being fulfilled. I think we should attract both those who are already involved in Clinical Trials and others who are strongly interested in doing clinical trials in the future. The capacity of the auditorium is 100 people. May I suggest, based on all our contributions, that we have the following topics
  1) ICH/GCP basics
  2)Ethical Review/IRB and informed consent
  3)Overview of drug discovery and development
  4)Good Laboratory Practice
  5)Quality Assurance and Quality Control in clinical Trial
  6) Group discussion on Team work and Clinical Trial Project Management including the challenges of conducting clinical trials in Nigeria and way forward.
  7)Introduction to Global Health Clinical Trial and Professional Membership Scheme
  If you have expertise in any of the areas, you may indicate your willingness to take a specific topic. If you know of somebody who has expertise in any of the topics but is not part of this discussion, you may want to contact the person and find out his/her willingness to participate in the discussion and be a resource person. I guess once we agree on the topics and have all the resource persons, the editorial team will move on from there. Can somebody please respond to Emmanuel's concern on HIV test Gold Standard. Many thanks to you all.

• AUGUSTINE ONYEAGHALA - Senior Contributor 19 Feb 2012

  While we thank Glory for all his efforts thus far,I think that some of the issues raised by Sani make some sense. One does not know the type of audience that shall be attending this meeting.Will all the attendees be clinical research professionals? If the answer is no, I should therefore strongly suggest that we concentrate on the basics of clinical research eg
  ICH/GCP basic
  Informed consent
  Ethical Review/IRB
  Cultural Issues in Clinical Research
  Fraud in clinical research
  Data Quality in clinical research
  GCP/GCLP. etc.
  Having spoken locally and Internationally on variety of clinical research topics, I could volunteer to deliver a session if room still exist for resource persons.
  Thank you for all your contributions.

• Shamsuddeen Sani 18 Feb 2012

  Glory Oluwagbenga Ogunfowokan you have put forward a good effort by organising this program.

  However, I have some suggestions with regard to the arrangement of the topics as I found them rather mixed up a little bit.I apologise for being so critical but when it comes to clinical research,clarity, frugality and precision are the watch words.

  The theme must reflect the sub-themes at least in broader sense. So that may need to be garnished with topics such as: Challenges of Conducting Clinical Trials in a Developing Country.
  Secondly, you can not have a topic: Product discovery and development of tropical diseases in Nigeria. It’s rather vague. What do you intend to discuss there in 30 minutes? What do you mean by adding ‘tropical diseases’? Do you meant to say drugs or vaccines for those tropical diseases? Which ones among dozens of them would like to discuss in a short time to such an audience of clinical trial naive individuals?
  You could rather say: Overview of Drug discovery and Development. Simple.
  Thirdly, it’s almost impossible to discuss judiciously in a single lecture on Data Management, Quality Control and Statistical Analysis. These are broad entities managed separately by different teams in clinical trials. It’s perfect to make a separate topic each on:
  Clinical Data Management
  Quality Assurance & Quality Control in Clinical Trials
  Statistical Analysis of Clinical Trials
  Medical Writing in Clinical Trials
  The Role of Pharmacovigilance in Clinical Trials
  Other subsequent topics you have also need to be reframed as follows:
  Role of the Regulatory Authorities in Clinical Research
  Institutional Review Board/Ethics Committee and Informed Consent Process
  Good Laboratory Practice (GLP) and Good Manufacturing Process (GMP)

  The interactive session could focus on: Team Work and Clinical Trial Project Management.
  Your first topic on ICH-GCP is in order. Thanks.
  

• chidemannie 17 Feb 2012

  Thanks much. Whats the capacity of the hall/conference room? How many persons are planned for? I believe this is the first step as regards numbers of participants. I said something about the HIV gold test standard that is not and no one reacted to it.

• Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead 16 Feb 2012

  Impressive! I got an official letter today approving us to use the National Hispital Auditorium on May 7, 2012. We are also given 50% payment waiver. So, we pay would N12,500 instead of N25,000. My suggested theme is CLINICAL TRIALS IN NIGERIA- WAY FORWARD. The topics to be covered may include
  1) introduction to ICH/GCP
  2) Product discovery and development for tropical diseases in Nigeria
  3) Data Management, Quality Control and Statistical Analysis
  4)Ethics Committee, Regulatory Authority and Informed Consent
  5)Good Laboratory Practice
  6) Interactive section on managing a research team and Collaboration in Resaerch in Nigeria.
  7)Introduction to the Global Health Clinical Trial and professional membership
  I guess 6 topics with 30 minutes tea break and 1 hour lunch may stretch from 9am till 4:30pm. Those with expertise in any of these areas may volunteer to take the topics. The power point presentations should be made available to Global Health Trial Editorial team ahead of time for their suggestions and contribution. Once we tidy up all these, publicity material should be made available by the editorial team as we continue to prepare for the D day. I would not mind giving a talk on product discovery and development for tropical diseases in Nigeria. My fear now is that we may have more participants than we are anticipating so that we dont have the problem of inadequate resources. So, should there be a limit set ahead of time and if so what will the criteria be. What do you all think about this?

• Morenike Ukpong 16 Feb 2012

  And I forgot to add - NHVMAS would be glad to support the meeting with lots of resource materials - educational leaflets on research literacy, ethics training handbook etc

• Morenike Ukpong 16 Feb 2012

  Thanks John for alerting me on the ongoing discussion. A date may not work for everyone but please do lets know early. NHVMAS will be glad to help share information on the meeting via its listserv. We have access to about 5000 persons - a bulk of whom are in Abuja and may well be interested. There is also the Clinical Trial Network in Abuja who I am sure would be glad to collaborate with you on this. The AGCPN whom John mentioned would also be glad to work with you on this. A theme for the meeting may be great and a catchy one helps draw attention. I suggest for a day's meeting, topic should be limited to 5. Topics related to clinic trials are interesting, many people are learning things for the first time and they would want to ask and discuss a lot of issues. I suggest room should be given for lots of discussions and deliberation (and conclude on time for people to leave for school run etc. Possibly by 400pm). All the best as this is being put together. Would be glad to replicate the meeting down South for persons who may be interested but cannot make the trip to Abuja (there would be a lot of residents who are currently planning their dissertation who could well benefit from the sessions).

• FALAJU OLUWASEGUN DANIEL 16 Feb 2012

  I am new to clinical research, good clinical practice and quality assurance and i have been taking definite steps towards enhancing my knowledge by joining the nigerian chapter of SQA and taking some online courses and trainings in this regard. I have been privileged to take some global health trials courses and i find them really informative and educating. So the conference will make a good forum on adding knowledge and interacting with the great minds in this field.

• AUGUSTINE ONYEAGHALA - Senior Contributor 16 Feb 2012

  It is nice identifying with this group. Thanks to Maduabuchi for introducing me to it. As a Clinical Research Associate and Biomedical Scientist, I shall always be available to offer my expertise to this group, hoping fully that it will help open the clinical research industry in Nigeria. The workshop to be held in Abuja is a welcome one. All hands must be on deck to make it a successful one. I am sure with the crop of Clinical Research Professionals we have here, resource people is not going to be an issue at all.

• The Editorial Team 16 Feb 2012

  Hi all

  Thanks for your input. Glory - how is the plan for the room coming along?

  Global Health Trials will be funding the room and refreshments, and the meeting will be free to attend - but we are not able to cover people's travel expenses and so on unfortunately. If you have further queries do contact me.

  We are happy to help with posters and flyers once we have the talks sorted out. It's absolutely fine to follow the Nariobi format if preferred, but really the aim of these workshops is to cover as broad and interesting a range of topics as possible in the field of clinical trials, to be suitable for the whole research team - investigators and clinicians, nurses and data staff, statisticians, lab technicians, and so on. We'd like one talk on Global Health Trials and the professional membership scheme, to encourage people to make use of the resouces available.

  So, I suggest that we work with the people who've kindly volunteered their expertise to work out a schedule based on their expertise/what they are happy to talk about. Glory - do you want ot take this forward, or would someone else like to do so?

• John-Moses Maduabuchi 16 Feb 2012

  Thanks for all your contributions. I will reach few persons today including Dr Morenike Ukpong who was with us in the GHT forum last year and see if they would be available to be part of this.

  Considering the topics, do we want something different from the Nairobi format? I thought it was recommended that we work with the template.

  Timing and resources are essential, but also the funding. I had asked about this before. I would expect Tamzin or Trudie to respond to that.

  Can we hold the meeting in another venue in Abuja, if the the National Hospital Conference Auditorium is not available on the date we would prefer?

  What is our target audience, and how do we want the meeting publicised? Email alone and internet can get enough people, but posters and fliers will help if we want widespread publicity that could leverage awareness for subsequent meetings.