Less Rigid Practices Required to Deliver
Widespread Uptake of EDC in Phase IV
Phase 4 is the fastest-growing area of clinical research today. A changing regulatory environment,
growing concerns about the safety of new medicines, and various uses for real-world data on
marketed drugs’ safety and efficacy are primary drivers of the growth. We need to improve the
way we support the clinic and site staff to successfully implement EDC in Phase IV.
of clinical data into an EDC system. No clinic will refuse additional resource but this situ- ation only prevents the clinical team from getting other derived benefits. The flow for the successful conduct of a clinical study has been simplified through EDC, but instead of into the nature of support required. More allowing the clinic to observe, understand and take these advantages often these ben- population. Given the recent high profile efits from the system are kept from the clin- ical team. Why is this happening? The early place, as well as the identification of new the same issues seem to arise. Has there task rather than a system that could assist seen with Tysabri it is difficult to argue the clinical staff. Electronic data capture is no longer equivalent to remote data entry It will necessitate that research is con- Phase II and III clinical units, which consti- Let’s take a look at third party helpdesks tute a relatively small number of prescrib- ers. The infrastructure required to conduct reports 80% of calls were to do with pass- a clinical study may not be so well-defined an electronic CRF, available for 4 hours 7 therein. The principal resource is profes- you shop on line, bank on line, pay your bills on line or just share photos and sto- required for 4 hours 7 days a week. “Fol- ries with your friends on line you always but who may only be part-time clinical tri- low the sun” is a sound bite designed to have access to a forgotten password link. alists. Phase IV studies will not be possi- reassure that as the sun rises on a working ble at Phase II and III study costs, often an email address registered with the sys- who will look after your study in the event We need to make it easier for the clinics that a clinical staff member has a question. to conduct Phase IV studies and give them The clinical staff work local hours, as do adequate and sufficient support. The major- Regulation 1.11 utilise this system. Since ity of Phase II and III studies now utilise the might like to think they do not work week- web for data collection (electronic data cap- ends or at midnight to finalise study data. completely reduced the request for a new ture (EDC)). The advantages of wider distri- bution of sites and faster data collation are tronic media are obvious. But some bizarre sive response rates, but they do not have Data from a call centre (October 008) behaviour exists in the support structures for clinical study expertise. They can quickly indicates that the primary method of com- Phase II and III studies. The author is aware munication with the 3rd party helpdesk is of companies who send data entry special- question or are they truly interested in the ists to sites to assist the site with the entry received than telephone calls. What this 1. Per Patient cost is an indicative figure of total study budget divided by the number of patients. It includes all aspects of a study including pharmaceutical company costs, regulatory costs, investigator administration costs and overheads. desk successfully resolved these questions also indicates is that the person requiring to the satisfaction of the clinical staff at ryone is available for training. What hap- the first time of contact is unknown. Such response and in this situation a response the clinical staff working week. Another measure of a successful helpdesk. What is employee) is better than a good response not available is a listing of these questions initiating thereby putting another obsta- and this information does not always get fed back to the EDC provider. Because of that 80% of calls are in English. CTEP has If EDC has only replaced paper why has a this, potential improvements for the sys- whole new industry in EDC-training grown tem and the end-user (the clinical staff) called “Ask your CRA” which distrib- utes questions from clinical site staff to a to use, EDC should be easier. Clinical staff place a barrier to end-user feedback and sponsor distribution list also reduces the are mostly internet users. They too shop on line, bank on line, book flights on line, In a Phase 4 situation strategies to reduce allows a consistent answer to be provided transact on line. Why do we think they can- to site staff. Another added advantage is not navigate an EDC system? But booking a that it also informs the sponsor of where flight is not the same as conducting a clin- must be provided with systems that allow ical study is often the response. Clinical them to support their local clinical units in provided in the protocol. This allows fea- a timely manner. These staff are the most tures such as Frequently Asked Questions ture and an EDC system presents this in an (FAQs) to be built into the system. Email ple to do this. EDC systems which are so distribution, FAQs and on-line tips reduce clinics to become more organised in their intuitive that they require no training must processes and provides the infrastructure be provided to the clinics. EDC must not be party helpdesk support and gets informed required to conduct studies in a Phase IV reduced to a data entry task. The PC resides on their desktop and while it might today still be considered an intrusion on a patient ments for the conduct of a clinical study. sick patients want to be able to do their consultation it is here to stay. It brings ben- jobs with little or no disruption. No met- rics exist for the impact of this training on formed by doctors and nurses in order that the data quality or timeliness of its report- training, ICH Topic E 6 section .8 states that “each individual involved in conduct- training improves quality. Clinical staff do ing a study should be qualified by educa- not want cumbersome process artificially Moving from paper to electronic is still tion, training, and experience to perform his or her respective task(s).” In section lose staff to ill-timed, inappropriate train- 4 the regulation states that the investiga- ing. They want help when they request it, they need road side assistance. Again the is, what will be the EDC tipping point for the appropriate use of the investigational sponsor personnel with clinical and data organizations that don’t have deep finan- product(s), as described in the protocol. cial pockets or for Phase IV studies, with The investigator should be aware of, and 008 informs the author that 34% of all the regulation or guidelines does it state that the investigator must be trained in were “how do I” questions e.g. how do I do find the adverse event form, how do I tinues to evolve and software as a service a training programme is prepared it fails withdraw a patient etc? Whether the help- “Varied and informative. We’ll definitely be coming again as we met
many new people. Very impressed”
Joanne Fry & Louise Bickerdike – PhaseForward
on smaller budgets. SaaS is about rent-ing software when you want it for as long as you want it. It is maintained and sup-ported by the provider and essentially is your EDC-requirement outsourced. The SaaS model allows predictable and afford-able monthly costing rather than high license fee costs and has favourable prac- tical implications for organisations, e.g. as an operating expense, departments can more quickly seek budget approval to implement a SaaS solution. SaaS presents a mechanism of lower barriers to switch-ing, such that you do not get stuck with your EDC-choice long term.
the need for sponsor personnel to visit a clinic, we must release EDC with little or no training, confident in the knowledge that they can use this tool and provide ade-quate knowledgeable support through a sponsor’s own staff rather than third party helpdesks. If a clinic cannot use the cho-sen EDC system without training then you ‘MHRA Inspections’
have simply chosen the wrong solution or provider. The CRA needs to be trained to promote the benefits of a changed proc- ess, not the site trained on internet trans-actions. Finally, by utilising companies who promote software as a service, EDC Tuesday 9th June 2009
costs can be affordable to all companies, Wyeth, Taplow, Maidenhead, Berkshire
Support data sources include:
This one day meeting will cover key aspects investigational sites, pharmaceutical companies • Professor Peter Littlejohns, NICE at and Clinical Research Organisations. The Irish Platform for Patient Organisation, meeting is appropriate to staff from all clinical Science & Industry (IPOSSI), Nov 008 development disciplines. Presentations will include recent MHRA experiences, ‘hints and tips’ for MHRA inspection readiness and an Sanofi-Aventis at eClinical Trials, May 008 Please promote and support this event.
For more information visit the
Tomas O’Mahoney,
Operations Director, CTEP

Technical Meeting Committee web pages at


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