Managing Risk in eClinical Technologies and Decentralized Clinical Trials (DCTs)

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Questions and Answers:

What are the key indicators of success for suppliers (for example a mature quality department)?

Certainly risk management is a key indicator for a successful audit. Also seeing that:
1. Records are consistent and complete
2. The organization is audit-ready
3. There is effective use of tools for quality management. There are quite a number of activities and if everything is being done on paper and spreadsheets, that’s not the best, so use of tools is a good indicator.
4. Another key that I think gets overlooked is training. Everybody knows we need training records. But the organization should take training very seriously and the training should go beyond just reading and understanding SOPs. There should be a lot of training programs in place, with supervisor oversight of training within departments. They show a good, mature quality management system and that they’re going to be successful.
5. Finally, when I get the impression that there’s a culture of high-quality data integrity, doing things right the first time. When you’re interviewing people, you can get that sense of that culture pretty quickly.

I think they are some of the keys to success.

Could DCTs create a bias in the sample included in clinical trials as only those subjects/ investigators/ site staff comfortable with eClinical technologies, and that have access to the technologies, can benefit from them?

I think there’s bias in brick-and-mortar studies, because only people who can take off every Monday for two hours can participate. You have a bias inherently. Is there another bias for technology? Possibly. Certainly, if you’re requiring people to have the latest smartphone and download apps.

How are patients recruited in DCTs?

Given that more patients are being recruited outside the clinic’s practice, there will be more reliance on digital channels to raise awareness and create a call to action. In any case, recruitment should always be a multichannel campaign, even in a traditional brick and mortar model.

Thanks Joseph for the presentation. I agree we have to stop thinking in sequential processes, nevertheless, it is the most difficult part as many activities are still sequential, can you provide some examples where you conducted activities in parallel?

When I was a customer at Lilly (see ProofPilot case study) we had been developing the study in the platform well before typical documents were finished that usually serve as inputs for EDC/ePRO service providers. As this is a new innovative paradigm, there isn’t a long list of examples yet to point to. But I am very confident this a capability all sponsors can take advantage of.

Can you share the challenges just mentioned?

Here’s a Linkedin post covering them:

The FDA has said they will be revising many guidances with regard to DCTs…do any of the speakers have a sense of how major these revisions will be?

I really don’t have any sense of how major the revisions will be. I do know that with quite a number of guidance documents, the amount of time it takes to get the guidance documents out through the whole process of legal review is turning into years. We have to assume that we’re not going to see a particular guidance document any time soon. That’s the best answer I can give.