ARTICLE




             Capturing the
             Impossible: an eDC
             Adventure into Africa
             Thu...
ARTICLE



I had set the ‘go no-go’ decision date to          No stones were left unturned as we             with the tech...
ARTICLE




             ISSUE
P A G E 14
             64
ARTICLE



nicating with each other via their own         internet access within fifty kilometers. Yet,    and the number o...
ARTICLE



functionality, we had just added unsched-         A couple of hours north of Dar es          was beginning to r...
ARTICLE



   Eventually we made our way back
to Nairobi in Kenya and up to
Eldoret, Nambale and Busia on the
            ...
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Capturing the Impossible: An EDC adventure in Africa

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Timaeus uses a mobile-friendly, highly-distributed architecture than enables investigators to capture, validate, synchronise and manage drug discovery data from anywhere in the world -- in real time. Read about our work using Timaeus to perform real-time EDC in the heart of East Africa to aid in Malaria vaccine development.

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Capturing the Impossible: An EDC adventure in Africa

  1. 1. ARTICLE Capturing the Impossible: an eDC Adventure into Africa Thursday 6th December, New Jersey, US. As I sit at my desk in my heated apartment, I gaze out the window past the Christmas lights and onto the snow-covered roofs. It’s a far cry from the views I had less than two weeks ago when myself and my colleague were on the equator completing the last leg of an amazing trip... a trip that involved fifteen flights and around fifty hours of flying, visiting six countries, coordinating a project team over three continents and four time zones on a daily basis, and all in just four weeks; a trip to demonstrate the feasibility of (RR) eDC – (Really Remote) electronic data capture in Africa using Timaeus – Cmed’s answer to capturing clinical data in Africa... ISSUE P A G E 12 64
  2. 2. ARTICLE I had set the ‘go no-go’ decision date to No stones were left unturned as we with the technology team and checked all Friday 12th October and this was cutting it packed for the unknown. Hand-sanitizers, of the equipment that made up the ‘field close. After all, there were numerous sun block, compass, iPods, GPS, shades, kit’. There was lots of it and our packing activities requiring immediate attention if hats, ear-plugs, more medicines than a skills were pushed to their limit. Essential- we were to stick with the proposed plan of well-stocked pharmacy, and we had yet to ly we would be taking four small laptops, a departing the US on Wednesday 31st pick up the ‘field kit’ in the UK. Getting all mini satellite dish, lots of cell phones, our October to liaise with the UK project team of this gear on board would surely involve new eDC tablet and an assortment of the next day in London. The green light an Herculean wave of creativity. It did! cables and chargers that would make even for the project came two days early as the The last two weeks before the departure the geekiest heads spin with excitement folks upstairs in Cmed and our pharma- from the US were spent confirming flight and envy. On top of this, we had personal ceutical partner agreed that the demon- schedules, hotels, local transport, meet- laptops and enough camera and video gear stration of a successfully simulated eDC ings with site staff and finalising all project to rival Nikon Africa™. study, run across three African countries and pilot study documentation. Neither I We arrived at our first destination, the with ten geographically unique centers nor Jerry had been to sub-Saharan Africa capital city of Burkina Faso, Oua- over a four week period, would be very before and we were pretty excited on the gadougou, at nine in the evening on Sat- much in both of our interests. The key way to Newark airport. We had no idea of urday 3rd November after about six hours word here being ‘success’. Two things what lay ahead. Now that’s what I call a of flying and a brief stopover at Charles De would contribute to that success – or lack good day at the office! Gaulle. We were still on GMT! The first thereof; a carefully executed plan and an striking thing was that apart from the electronic data capture system like no native languages, Moré and Dioula, “Within minutes my hotel other. The latter was being configured in French was the language of choice here, London as I ran about the East coast of room looked like the central and English was spoken by very few America worrying about the former. operations room for an indeed. I had enough French to get by and As I mentioned earlier, I was to travel was very glad of it. The second striking with my colleague Jerry, training manager intelligence agency. Jerry was thing was the heat, and by the time we for Cmed in North America. I had on the balcony positioning the cleared immigration and health checks worked and traveled with Jerry plenty and and retrieved our luggage, we were knew that we would work well together. mini satellite dish in an easterly drenched. On exiting the airport we were After all, for a trip as intense as this, it’s direction with one hand while greeted by an unusual sight (and sound) of simply a matter of ‘get on, or get away’. a local brass band marching past and play- fighting away giant flying We’re still talking... ing ‘Glory glory Alleluia’. Then came the The plan was in place and we both had creatures with the other” line of street hawkers. Eventually we checklists in every pocket. Most impor- made it to the comfort of our hotel in a tant were the immunization shots and the On arrival in Gatwick, we made our way people carrier that was held together by visas. Knowing the importance of the to Cmed’s offices in Horsham and follow- seemingly nothing other than a fear of shots, we had gambled on the project ing a quick shower and change of clothes falling apart. We were excited, tired, but going ahead and had been turned into began preparing for the meeting with our full of anticipation. We had a job to do human pin-cushions a few weeks earlier. I partner company. We had set up a dedicat- and we would waste no time. The very only needed Yellow Fever since I was up ed operations room for the project where it first thing to be unpacked in our rooms to date on the rest; Jerry was not so lucky; would be possible to have a live real-time was the Timaeus, our eDC system. ET Hep A, B, Polio, Typhoid, Yellow Fever, view on big screens of the data that would needed to phone home! MMR, Tetanus... the list went on and on. hopefully be streaming in from the pro- Within minutes my hotel room looked He was a walking lab! For the visas, Jerry posed sites over the next four weeks. In like the central operations room for an had spoken to all of the consulates for the addition we had set up remote access for intelligence agency. Jerry was on the bal- countries that we planned on visiting our partner so that they could participate cony positioning the mini satellite dish in (Burkina Faso, Tanzania and Kenya) and in the action from their own offices. This an easterly direction with one hand while discovered that we could actually acquire was a simulated eDC trial in every sense fighting away giant flying creatures with all of our business visas in a single day in and all roles were being exercised; Data the other. I remained in the air-condi- New York. The specialist visa companies Managers, Lab Loads, Trial Administra- tioned room monitoring the four eDC sta- were quoting three weeks minimum and tion, Coding, Database Configuration, tions that were now all ‘live’ and commu- triple the cost! Database Exporting, etc. We also liaised Continued on page 15 ISSUE P A G E 13 64
  3. 3. ARTICLE ISSUE P A G E 14 64
  4. 4. ARTICLE nicating with each other via their own internet access within fifty kilometers. Yet, and the number of tickets issued. The WiFi network and with the rest of the the cellular network signal was every- lady sitting next to me was from Mali and study stations (in the UK) via the sat-link where, and so were their billboards; “Celtel she told me in excellent English with a from our balcony. I keyed in some patient – Partager. Notre Monde”. Our job was get- French accent data from our pre-prepared data scripts ting easier. Everywhere we left site staff “...this is part of traveling in Africa you and minutes later this information was longing for a data capture system like ours. know. They regularly invent excuses like available to all who had access around the Our initial anxiety was slowly turning into this when they have to fix some part of the world. We could sleep tonight. Tomorrow excitement as we realised the true poten- plane or wait for the crew to arrive...” we would be traveling to our first site tial of our system in Africa. Next stop, Tan- Great, we were surely about to miss our where we would demonstrate the system zania... or so we thought! connection on Air Kenya to Nairobi, and to them and hopefully enter and transmit then on to Dar es Salaam. We sat there for simulated patient data from the site. We three hours, despite being the only sched- would also be testing the other communi- uled departure (or arrival) during that cation modalities available to us, including time. As Leonardo DiCaprio says in his local area network and GSM (built into recent movie ‘Blood Diamond’ each eDC station). We stuck to coffee, toast and cereal for “TIA – This is Africa” breakfast, leaving the more adventurous Of course we missed our connections. options to other guests, and at eight thirty The only problem was that we had nei- were picked up by Yabo, as arranged. Yabo ther local currency nor visa for Mali and was a local who knew everyone and every- now had a requirement for both, as it where and was just the kind of person we seemed that we would need to stay in needed to know in such a foreign world. Bamako until we could arrange an He took us to the CNRFP the national , onward flight. It was late on Saturday center for malaria research, where we were evening, all computer systems had shut met by a team of very friendly research down for the evening, and being Sunday doctors and study coordinators. Following the next day, would not be running until introductions and a quick presentation, we six in the evening – an hour after the dialed in to our first daily teleconference scheduled departure of the next flight to where we were happy to report on our By the end of the week we Nairobi! After about an hour of running progress thus far. We held the proceedings around outside the airport without a visa, were communicating solely in French for the benefit of our hosts. That we eventually converted some dollars, day we also demonstrated successful con- over GSM and had purchased a visa, met with some airline nectivity using the LAN at site, despite the demonstrated a working representative and flagged a taxi to a bandwidth being too slow at times to view hotel – which only made it half of the way web pages. electronic data capture system before ditching us in a dark alleyway. I We had not yet managed to communi- in two very remote vaccination was beginning to think all adventure was cate using GSM (i.e. the mobile phone born in Mali. network) despite the ubiquitous cell sig- centers with generators as the Eventually we made it to our hotel, and nal. Our technology team needed to make only source of electricity and no even managed to secure onward flights to a few configuration changes to the system Nairobi the next day. And in a lesson of cabled internet access within so that we could use a local ISP rather , how to turn a disadvantage into an advan- than trying to dial internationally to the fifty kilometers. tage, while in the departure lounge of Mali UK or US. We found out very quickly that airport the next evening I logged into the international data calls were neither cheap The Air Burkina flight was delayed at eDC system as ‘trial administrator’ and nor reliable. By the end of the week we Ouagadougou airport. It had cost us five amended the database to include a new were communicating solely over GSM and thousand West African Francs to ‘con- country and center. I transmitted ten sub- had demonstrated a working electronic vince’ the airport staff not to have our jects’ data before I had to close the laptop data capture system in two very remote bags of equipment checked in the luggage and board the plane. We didn’t just boast vaccination centers with generators as the hold. Apparently there was a mismatch unscheduled visit and unscheduled page only source of electricity and no cabled between the number of people on board Continued on page 16 ISSUE P A G E 15 64
  5. 5. ARTICLE functionality, we had just added unsched- A couple of hours north of Dar es was beginning to realise that Timaeus was uled stops too! Roll on Tanzania. Salaam by taxi and we arrived in the his- a true ‘All Wheel Drive’ machine. It’s as if Following a long uncomfortable flight in torical Swahili town of Bagamoyo, once a I had only been driving around on Ameri- row fifteen (the non-reclining seat!) and a terminus of the slave caravan route. can highways for years and, now that I’d rescheduled connection in Nairobi to Dar taken the system off-road, I’d discovered es Salaam via Zanzibar, we finally arrived another gear stick, independent suspen- “Traveling rule number one, in Tanzania. I hated the place and every- sion and heated seats. body there. Deep down I knew that this the attractiveness of somewhere On the Thursday of week two, we would happen; traveling rule number one, new is directly proportional to returned to Dar es Salaam for a connecting the attractiveness of somewhere new is flight to Arusha, a town at the base of directly proportional to your state of mind, your state of mind, the content Mount Kilimanjaro at an altitude of the content of your belly and the amount of your belly and the amount of 1380m above sea level, home of tanzanite, of sleep you’ve just had. We were low on all and starting point for most safaris in Tan- three and it would take days to see that sleep you’ve just had” zania. Like everywhere else that we’d been Tanzania and its people were truly amaz- in Africa, there was excellent cellular sig- ing, just as it was in Burkina Faso. This was Within a couple of days we had once nal everywhere that we went, even in the true of all Africans that we met – east and again demonstrated to ourselves and the center of the famous Ngorongoro crater, west, and has greatly altered my percep- dedicated site staff that our data manage- allowing us to transmit and receive data in tion of this amazing continent. ment system was fit for the job. In fact, I near real-time. ISSUE P A G E 16 64
  6. 6. ARTICLE Eventually we made our way back to Nairobi in Kenya and up to Eldoret, Nambale and Busia on the Clinical Data Acquisition Standards Ugandan border, meeting with friendly site staff, demonstrating our Harmonisation (CDASH) The Clinical Data Acquisition Standards Harmonisation (CDASH) initiative is an FDA eDC system, setting up new centres Critical Path Opportunity (#45), www.fda.gov/oc/initiatives/criticalpath/ and all the time entering data, reports/opp_list.pdf which is led by CDISC with strategic direction and resources responding to queries that were provided by a Collaborative Group. being generated by staff in the UK and testing the system in a variety of Through this initiative, volunteers are working Implementing the CDISC Standards situations and environments. Each together to develop a set of CRF ‘content Development Process, initial consensus day we would report our progress in standards’ (element name, definition, versions for CDASH Package-1 (adverse a teleconference with project staff metadata) that will facilitate data collection at events, concomitant medication, around the globe. sites conducting clinical research studies. The demographics and subject characteristics) By the time we were ready to overarching goals of this initiative are: a) to and Package-2 (inclusion and exclusion leave Africa at the end of Novem- make it easier for sites to criteria, medical history, ber we had successfully used conduct clinical research; substance use, physical exam The Clinical Data Timaeus in four African countries b) to improve data quality and vital signs) have now to enter and transmit over four and patient safety and c) Interchange Standards been through internal CDISC hundred patients’ worth of data to contribute data Consortium (CDISC) Technical Leadership from nineteen geographically collection standards for Committee review and CDASH unique locations. While it may initiatives that promote mission is to develop Collaborative Group review. sound unbelievable, some of the the collection of data once and support global, Comments are now being data was actually entered and for multiple purposes. The addressed and the initial transmitted within twenty feet of initial scope is on safety platform-independent consensus versions refined. wild elephants and giraffe deep information that supports data standards that CDASH Package-3 (drug within the Masai Mara plains of all clinical research studies. accountability & exposure, enable information Southern Kenya. The first three CDASH comments & protocol Well now we’re back in the US, streams (sub-groups system interoperability deviations and disposition) the kit is back in London, and the comprised of volunteers to improve medical will soon be ready for CDASH post project meetings have begun. from pharmaceutical and Collaborative Group review. Personally, it has been an amazing biotech companies, research and related CDASH Package-4 (lab & ECG) experience and a privilege to have contract research areas of healthcare. is under development. The goal worked on this project and to have organizations, academia is to have all domains ready for experienced Africa and Africans and government from within and outside of open public review in early 2008. as I have. Regarding Timaeus, I the US) were initiated in October 2006 with The CDASH core team and CDISC wish to have no doubt that it will be an open meeting attended by over 80 ensure that an international voice is heard in returning to Africa in the near volunteers. Since that meeting, 9 Streams the development of standardized CRF data future and will be a key player in have been formed to develop the CRF content elements. Therefore, ACDM members are clinical trials of the future. standards for 16 safety data/domains, encouraged to actively support the CDASH specifically adverse events, concomitant initiative; this support can take several Daragh Ryan has been a medication, demographics, subject different forms – for example by reviewing Project Manager for Cmed characteristics, inclusion/exclusion criteria, the remaining draft CDASH packages and the since 2002 and has worked on physical exam, vital signs, medical history, final sets of data collection elements during a wide range of substance use, drug accountability, exposure, the public review period scheduled for early pharmaceutical projects in disposition, comments, protocol violations, 2008, and/or by joining CDISC. software development, lab and ECG. Rhonda Facile, CDISC business development, in clinical operations and in data For more information on how you can contribute to this effort, management. please e-mail rfacile@cdisc.org or visit www.cdisc.org/standards/cdash/index.html. ISSUE P A G E 17 64

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