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By Cathy Dawson, Director of Clinical Affairs, Aesculap
Cathy Dawson, Director of Clinical Affairs, Aesculap
Perching Atop The Three Legged Stool
Technology is supposed to make our lives better. The advantages seem obvious- data collection is easier, seamless, on-demand. An appropriately secured cloud based systems put data at your fingertips any time, anywhere that you can access a wi-fi signal. Data collection methods are multiplying.
As potential data sources for a clinical trial, technology is driving new opportunities to impact patient retention, endpoint collection, and timelier reporting of safety and efficacy signals.
In a world driven by metrics, how do you measure the impact of a technology upon a trial? Considerations include:
Beware the wolf in sheep’s clothing.
A seemingly straightforward decision to implement a technology can complicate operational paradigms for study team members, increasing both process management costs in headcount and in actual dollars to implement. Drivers include:
What to do?
Let’s start with a simple example.
In indication X, the FDA recommended endpoint is a PRO (Patient Reported Outcome). Technology expands the toolbox questionnaire data collection – a specific value within a long term trial where patient retention is a large concern.
One approach might be
Use multiple validated
methods for data capture
Primary data entry (Patient)
Secondary data entry (SC)
Points to consider
Viewing through the lens of patient retention, what could be better than a patient reporting experiential data directly? You would remove the burden of time and travel to the site; remove transcription time (and error) on the part of the study coordinator; and eliminate the monitoring issues as source and data are reconciled.
But consider first:
Validated imaging; Will the electronic image mean the same as the analog experience? Not always. How will you insure your data is still appropriate? Who will certify the digital translation?
Quality of tech support: A constant source of frustration is actually accessing the technology. Server speeds, down time, dead zones, or even the dreaded lost password can sow frustration and disenchant users- critical issues if you are also concerned with patient enrollment.
Robust processes: In the example above, robust GDP (Good documentation practices) need to be understood and reimagined for the digital environment. The common practice of correcting a questionnaire in an analog environment (initials date and crossed out data) may not translate directly into the digital world. (Fields editable for a set window of time -how long? who can edit? when? with a audit trail)
Learning curve: In adopting a new technology, the learning curve is inevitable. The cost of the learning curve cannot be easily assessed- but will certainly be measured in frustration, retention, disengagement, and ultimately lost time and money. It is further important not to lose site of the site staff in this respect- they suffer along with the rest of us. A final consideration is the patient’s learning curve. A poorly rendered or executed endpoint could jeopardize the entire trial.
Change Management: A detailed discussion is best left to the shelves of leadership books on the topic; however an organization approaching a new technology should have a strategy to manage and implement change without destroying the business culture of the team.
Boiling it all down
As a sponsor, the decision to outsource is an evaluation of risk and cost, and ultimately comes down to a decision by feel. The quantitative discussion centers around the actual cost of goods & services and the attendant FTEs for process management; on the other side of the scale weighs the qualitative concerns that will drive lag and trial failure- including the energy involved in change management, the impact of poor technical interface & customer service upon enrollment and patient engagement/retention, the potential turnover of contracted expertise and the personal/political costs of failure.
As a vendor, the proposal that includes a novel application or new technology can be a thorny path. While the advantages to new technologies seem straightforward (in this example, streamlined workload, minimized FTE associated with monitoring/data management- not to mention the excitement of a new challenge, a resume builder and the offering that tips the bid to your favor) the risks are different. Learning new technology amongst conflicting demands, friction from sites and sponsor can lead to burn out, hurt the business’s reputation and sacrifice future projects. In the case of subcontracted vendors, the full service vendor may loose out completely if the technology supplier fails.
In this environment, partnering with an outsourced technology vendor is the only safe way forward The technology supplier embraces the role of teacher and implementer; the sponsor acts as facilitator between customer and technology vendor. Open communication and trust is a mandatory.
Being partners, however, also means risk sharing. One approach is to include a plan B and a set milestone to switch when a technology does not deliver, or disenchants customers (patients and doctors) with an agreement that shares the cost of implementation. Other shareable risks include employee retention planning, patient recruitment management, and penalties for missed timelines attributable to service failure.
There is no one solution. But risk can be minimized when both the sponsor and provider commit to open communication; full discussions about process and problem solving; embrace learning and change; and share a definition of success.
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