tdp oc13 bostonjune2013.ppt - openclinica · • site data manger’s role can be adjusted and time...
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Investigator‐initiated clinical research in low‐resource countries in the South, with a partner in the North
Funding schemes focus more on scientific idea and capacity building
site selection not done based on site qualification
most big funders require capacity building component in project
DM and monitoring badly reflected in budgets
Resulting organization of a trial is decentralized – much of DM is decentralized into sites, with coordinating team supporting remotely and with regular data reviews
Infrastructure issues, access and communication
Internet speed
Patient follow‐up challenging (clinic diary always a challenge)
Rural areas, limited equipment, site usually part of reference hospital that is already overworked
Forced to use paper CRFs/DCFs
Clinical data management system is still in many places Excel or Access based (including EPI info) system
Many research sites do not have a central DMO, and those that do, put a lot of effort and human resources on data entry, fewer resources on DM
Clinics work with limited infrastructure; difficult documentation and retention of medical records and paperwork – but a clinical study requires unequivocally the opposite
Strong resistance of staff to using anything but paper.
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Staffing issues
Gaps in knowledge of CDM and use of software
Many times study budgets assumes DM will be executed by clinical staff (nurses or medical technicians)
High turnover of staff who gain the clinical research experience (to move to higher paying jobs)
Hierarchical and social obstacles to team work and delegation of responsibilities
Clinical research capacity
Most heard comment: “our trial will not ever be submitted to FDA or EMA for licensing, so we can bend the rules in how we implement and manage the study” – and not follow best practice
Second most heard comment “the trial protocol must be implemented in accordance with each site’s capabilities” – and not best practice
Clinical trials and DM used to be done all on paper, with scripts reconciling 1 & 2 data entry, and reconciling the work of one day into a batch update of the master dataset.
Procedures and practice were vastly different then
Many investigators are uncomfortable and lack understanding of how CDM and trial implementation has evolved, especially recently, with emergence of OC and other EDC platforms
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Challenges to implementation are as much political and consequence of preconceptions and culture, than are a matter of knowledge.
Fight the preconception: Clinicians are the researchers, other professional profiles are “support staff”
• This is often reflected in available budget for travel, CDM supplies/equipment, staff
• lots of teaching, workshops
• GCP usually done by national bodies, but follow‐up needed
• Laboratory, medical training (example BP)
• Study procedures, how to read study documentation, how to put CRFs into context of study
• How DM tasks fits in with clinic
• Required to set up a decentralized DM – separation of duties between site and coordinating DM
• Because of budget and protocol
• To develop capacity
Cannot avoid continuous capacity development
• Unfortunately a long‐term vision, but projects have definite duration
• Seeding the concept and meaning of quality – learning procedures and skills, question deviations, reviewing and comments are welcome
• Monitoring visit is in effect a combination of capacity building, source and data review and DM audit (different than in pharma)
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Monitor/CDM role becomes more important than in pharma trials
• the decisive role in study
• becomes a co‐manager of study
• Reinforce protocol procedures
• Regular dataset review with partial analysis of patient schedule and data
• Encourage creativity
• Empower DM and other staff in their local environment
Data management != data entry
• Resistance to CDM system also because primary emphasis of resources (staff and time) on data entry, secondary on queries
• Clinic staff can resist EDC because they equate it as the low‐end job of “data entry”
• Lack of skills in even setting up and maintaining a local OC instance for the site’s own use
Promote CDM as partner to clinic, especially to the clinical team lead (most often the clinician)
• through reporting
• continuous feedback
• Queries are not a bad thing
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Community Edition seems to suffice for the needs of the trials, although I would still recommend Enterprise package to any group that runs many trials
• barriers to site hosting and maintaining own OC instance
• Staff
• Infrastructure
• Slow handling of issues in issue tracker
• Not sufficient community support for “true beginners” ‐ One must know what they are talking about when sending questions to the user list
• System performance getting better and better
• Concerns over having to maintain local instances at each site because of fear of system unavailability are becoming less of a problem
• However, I am still excited to see ingenious solutions to how one can make OC work offline
• Therefore, emphasize understanding of the processes first.
• Focus first on training the staff on basic use of the system, as it complements form and data flows built on GCDM. Train in double data entry and query management functions.
• Secondary training in study set up in OC (study definition, eCRF design, rules)
• Tertiary training in server set up and definition of required infrastructure & staff
• Promoting OC use to reinforce the good CDM practice
• starting first with motivating and encouraging sites to learn study set up, and providing our own hosted environment (WHO and LMU do the same)
• Easy to distribute a VM with OC instance to teach study setup (I teach with a VM running on my laptop, and as I conclude the visit, give the team a copy)
• Great opportunity to advocate understanding of the scope of CDM and meaning of what it takes to get OC validated in accordance with regulatory requirements
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• Must use it as a data entry and data management system, and most often not for EDC
• Using OC as an EDC system in such a setting requires a very strong and decisive lead partner in study
• if no such presence in study, I would be pragmatic and recommend setting up the first study as a “paper to OC”
• OC is data management system – all discrepancies are managed in one place
• no more delays in data entry, emphasize a rhythm of CRF flow to DMO
• (example: clinic was sitting on CRFs and not sending them to DMO because the clinic decided to review the form to death before sending to data entry )
• Streamlining query management and creation of queries
• Monitoring tools available
• If study has a monitor, the basic tools are available for monitor to participate in management of work
• OC can be used to teach and reinforce the role of a dedicated study monitor
• Flexible DN management workflow
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Focus on streamlining the implementation of paper CRFs
• Examples of how data management is organized still:
• patient folder travelled with all forms to DMO to be entered, and then back to clinic (can you spot the problem here?)
• CRFs designed as a mix of clinical encounter checklist and data collection form
• Entry in Excel or other software; poor version control, audit trailing, data definitions
• When working with paper, there is a need for carbon copy forms – original stays in clinic, copy sent to DMO for data entry
• Cost is insignificant, but unfortunately PIs cannot always be convinced to spend the money for printing
• Drawback of not using carbon copy forms, is the use of the alternative – photocopying, creating many issues
• I use it as an excuse to force a cleaner and better design of paper forms; PIs/medical doctors have a tendency to attempt to hurry too much in form design
• Enough space around each question
• Clear coding of the answer of each question
• Reduce text fields
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• Site data manger’s role can be adjusted and time effort shifted toward data management
• Major effort is still appropriate management of paper forms and the sending of forms to DMO
• However, DM’s time effort shifts away from data entry (and reconciling 1st and 2nd data entry) towards data management
• Empower and motivate the staff
• If a DM is at the site, opportunity to empower the DM by teaching the DM to spend the newly available time in more advanced quality control activities, and reporting
• If the DM is done by clinical staff, the system simplifies communication of what needs to be done
• Overcome resistance due to fear of losing jobs – retraining in role and skills of DMO needed
• Develop data entry clerks with skills as well – medical coding, organization, internal audit (data manager sees opportunities in expanded responsibilities, but data entry clerks can feel that they loose importance)
• Multilingual support helps with site acceptance
• 3.1.3.1 is what we currently use with French/English
• Another study I partially run in Spanish/English (only queries are multilingual)
• It works, but unnecessarily complex to manage and set up
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My wish list ‐ community
A community which is sufficient resource to a determined individual with limited knowledge and resources, to run the system adequately
My wish list ‐ functionalities
Better thought trough support for multilingual studies
E‐diary, patient management/scheduling system (but only if practical!)
Improve documentation of web services – allowing integration with systems such as a randomization system (we use ALEA)
Live reports on status of notes, per site
Functionality reviewed for satisfying needs of paper‐to‐OC and EDC use (do not drop double data entry functionality)
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