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RxTrials welcomes Gregory Osgood, Director of Clinical Research Operations at Delta Waves Sleep and Research Centers as a guest blogger who wrote the below post:
Clinical development still looks like a series of free-for-alls that can easily cause failures. Meanwhile, costs and time invested climb like our national debt. There is pressure on sponsors, CROs and sites to do better. No one is happy about how things are going. There is plenty of upside for improvement.
Two areas that have gotten nearly as much attention as Charley Sheen are technology and collaboration.
We’re beginning to realize the potency, for instance, of designing portals that can help bring order and efficiency to the clinical trials cavalcade. Beyond the ability to collect data faster and cleaner, EDC systems are perfect for enhancing study management and centralizing communications.
If we’re employing EDC, why not use it to integrate IVR, manuals and guides, and lab results? This allows everyone to work in one virtual place.
Better yet, smart systems allow study managers to easily see trends in the data as they develop and to determine if a region, monitor or site is having trouble. Managers can tell if an eCRF page is confusing, or contains an error. Managers can identify how to use resources and support study sites. They can truncate mistakes and move sooner so that we can take appropriate action together, which means less work and costs for everyone. An EDC portal is a natural place to post and disseminate training, refreshers and updates.
Much of what used to take tons of time during site visits can be accomplished sooner and faster via the internet. This would cut down visits - something we all want. So far, too cool. But there’s more.
If study managers have performance data, give it to me too. This way, I can see exactly what my team is doing well, and I can work quickly and in concert with the manager when we discover problems. That would be real collaboration. I can report out internally how we’re doing, and better manage my responsibilities. With a nod to Jerry McGuire: ‘Show me the data.’
I recently found a company that provides this sort of technology. Their system doesn’t have everything I’d like, but still looks promising. They say that they want to help sites do better. Yet they also say that their system is the way to drive recruitment, enrollment and site performance.
My response? ‘Wrong and foul’, for two reasons.
First, technology doesn’t drive anything. People do. Second, ‘driving’ sites to perform better evokes a really unpleasant reaction in me (and I don’t think it’s just because I’m a New Yorker). Who says trial sites can or should be driven to anything- like we won’t perform well unless we’re driven? Everyone wants to do a good job. And there are plenty of data that show superior results when people are positively motivated to produce.
So tell me, Mr. Techno-vendor, that your technology can make me more efficient and my job easier. Tell me that we can work better together, because your systems can do that, and I’m with you.
But, what if these systems could do more?
Designers are making these products so that they are ‘painless’ for us at the sites. Why not make them fun and engaging? How about making them enjoyable to use? Wouldn’t that encourage productivity? The concept works in other businesses. It would work for me.
Here’s a few ways you can do that. Design the system to recognize and congratulate us when we enter data faster and cleaner than we have before. Have it generate a certificate so that our team can show off. Have it award performance points for a competition, where the winners would have a donation to a patient group made on behalf of the site. Design it to identify study expertise and to identify a coordinator as an expert whenever she’s on line or in a webinar. Promoting achievement and enhancing gratification are the ideas here.
Incorporating things like this into business and educational applications have jacked up work effort. In fact, when people become thoroughly engaged in what they’re doing, they don’t see it as work at all.
There are other things that can make these systems engaging. The point here is that we spend lots of time and effort voluntarily doing things we enjoy. That’s better than avoiding pain. It’s much better to incite people to propel themselves, than to try to ‘drive’ them.
Technology is great, let’s really use it. Show me the data. Don’t try to drive people, engage them. If we really collaborate we can make the serious business of clinical trials more efficient - and more fun. How about it?