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My RBQM predictions for 2022

It’s become a tradition. Every year I make RBQM predictions for the year ahead. For 2022 I have five big predictions.

More GCP Changes

We know from E6(R3) and E8(R1) documents published last year that ICH are planning more updates related to quality and RBQM, we just don’t know when exactly. We do know that the public consultation for E6 (R3) is due to start in October, so we’ll have a good view of what the final guidance is likely to be with an expected move to stage 4 in 2023. updates are likely to focus on the further modernization of processes and use of technology. The ICH appear to want to take advantage of the increasing use of risk-based approaches, especially those driven by new and emerging technologies, and the increasing use of decentralized clinical trials (DCTs).

Cyber-Security increasingly important in RBQM technologies

This one might sound obvious, but reported a 50% increase in cyber-attacks on organizations in 2021, rising to over 900 attempts per organization a week in Q4. We are all under constant attack, and that’s frightening. Not least because in clinical research we’re dealing with confidential sensitive data from more data sources than ever. On top of this there is also increasing risk with more people working from home and accessing information through potentially unsecured networks and devices. RBQM technologies will see a big uptake in security features such as multi-factor authentication and single sign on.

The relentless rise of DCTs and its marriage with RBQM

After the pandemic there’s no going back – DCTs are here to stay and will become even more important in 2022. But DCTs come with increased complexity, risks, quality concerns, and safety risks. These include new technologies, a move from site-focused to patient-focused data, the accuracy of patient data entry, and the need for data standardization and aggregation. All these factors mean that RBQM will be the enabler for DCTs because it identifies and manages those critical data and processes, and their associated risks.

RBQM focus on the patient

DCTs aren’t the only thing driving patient focus. Last year saw a 25% increase in investment in clinical research according to This means a lot of new studies starting in 2022: an estimated 18,000 Phase I and 23,000 Phase II. From an RBQM perspective that means smaller shorter duration studies with smaller data sets. RBQM has traditionally been focused on delivering monitoring efficiencies in Phase III and IV trials. But with Early Phase you’re dealing with tens of patients, not the hundreds or thousands so those efficiency gains aren’t there. That means RBQM technologies will have to focus more on the safety and quality aspects, and at the patient level rather than the site level. This creates opportunities to compare patient data sets (e.g. sex, age, ethnicity, similar medical history etc.) to perform much more relevant analysis and get more statistically significant outcomes.

The Audit Trail leads to data gold

The audit trail feature in RBQM technologies like OPRA will become increasingly important. That’s because the ‘data about the data’ gives you significant insights into what’s really happening in your trials. Knowing who entered what data, who changed it, when it was changed, and how many times it’s been changed is hugely powerful when it comes to assessing risk. Aggregating audit data up to the site or study level (including for DCTs) shows you patterns and trends about what’s ‘normal’ and where further investigation is required. In Early Phase trials, the audit data can also give you important data to supplement the relatively small amounts of primary end point data, and allows you to demonstrate high quality risk management and patient safety.

If you have any comments, insights, or disagreements with my predictions I’d love to hear from you. Please email me at If you’d like to see how well I did with the predictions I made in 2021 please go to

And a very happy and successful 2022 to you all.


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