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Risk-Based Monitoring

Risk-Based Monitoring

What is WHAT-2-SDV

WHAT-2-SDV is a service for risk-based SDV that improves the quality of data in clinical trials. This has been developed together with CRAs to ensure that it supports their monitoring visits and is both intuitive and easy-to-use. WHAT-2-SDV is a proven tool that is used on a daily basis by CRAs in more than 70 countries for almost 3 years. The system has overwhelming support from the CRAs, especially how it helps them to plan their visits and save time. The system specifies what to SDV for which patient, and so they no longer have to do 100% SDV. This now leaves them more time to amongst others, perform GCP checks, staff checks and training, look for fraud and check compliance issues. WHAT-2-SDV integrates with all existing systems and can be used with minimum training. It can be implemented within 2 months.

Risk of not performing 100% SDV

Studies have shown that less than 1% of data is changed due to 100% SDV, and the effect of this change on the primary analysis is negligible. Therefore quality risk is not directly affected by 100% SDV. It was also often thought that regulators preferred 100% SDV, and therefore not to do this may raise quality risk concerns. However, recent papers from FDA (Guidance for Industry - Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring, August 2011) and EMA (Reflection paper on risk based quality management in clinical trials, August 2011) are positively encouraging pharmaceutical companies to abandon the 100% SDV approach in preference to a more risk-based source data verification.

Time to stop 100% SDV?

Quality risk management in clinical trials is often interpreted as risk elimination when it comes to SDV. Pharmaceutical companies attempt to eliminate risk by performing 100% SDV. However, the cost of on-site monitoring is now around a third of the cost of a trial, so performing 100% SDV is a very expensive method of eliminating risk. On-site monitoring involves many more tasks than just SDV, including tasks that are important for the overall quality and compliance, and so must be performed. So how does the monitor perform 100% SDV and all the other tasks without spending an inconsiderate number of hours at the investigator site?

What is centralised risk-based SDV approach?

Centralised monitoring can be thought of as moving a little bit away from manual and subjective process to an automated and logical process. As things are programmed, it is also possible to then identify key data issues for the monitor to check, and therefore in effect ask the monitor to target their SDV, and just check the data which they are asked to check. This process has a risk associated with it, as the monitor is not performing all the checks manually, and they do not look at 100% of the data. However, the advantages of automating these processes far outweigh the previous manual process.

Advantages of using WHAT-2-SDV for a centralised risk-based SDV approach

Systematic errors are easy to spot by looking at data trends and protocol violators

  • Data errors, outliers, missing and inconsistent data are identified with programs and logic rather than the luck of the eye
  • More complex fraud checks and statistical analysis can be programmed
  • Site characteristics and performance metrics can be monitored over time by looking at high screening failures rates, eligibility violations, delays in reporting the data
  • The automated checks can be submitted routinely on the database without the need to visit the site
  • CRAs have less data to check when they are at the site, and so can not only verify the data, but they actually have time to check the data
  • CRAs have more time to perform GCP and Process checks, and provide more training at the site
  • CRAs visit sites with issue more often and spend longer time there, and visits sites without issues less frequently

Risk of using WHAT-2-SDV

WHAT-2-SDV is taking a risk-based approach. So by definition there is an element of risk that some mismatches between source data and the database maybe missed. It can also happen that the risk assignment is wrong. The risk factor should therefore be continuously updated based on the latest data, meta data and CRA feedback. This will mean that the risk factor will increase over time for risky sites.

Conclusion

Although on-site monitoring can cost around a third of the total trial cost, the quality of the trial data must be unquestionable. Quality risk management is therefore essential. Applying a centralised risk-based SDV approach will reduce the amount of data the CRAs have to verify at every site, allowing them more time to target problem areas, whether that means visiting specific sites more often or specific issues within a site. WHAT-2-SDV is therefore the perfect solution. This will not only increase the chances of identifying data issues, both random and systemic, it will also help to check for fraud and increase the quality of the trial. As more time will be spent on automatic checks, and less on on-site monitoring, the overall cost of on-site monitoring will be reduced, and the savings will increase as the size of the trial increases from small to medium to mega trials.

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