Over the past few years, we notice a dramatic increase and change in the complexity of clinical trials. Nevertheless, there are things that haven’t gone through severe alterations and still preserve their initial functions. For instance, sponsors are still responsible for ensuring that all of the participants in one study or another are safe and that the integrity of data attained from the medical research is adequately maintained.
Monitoring of clinical trials also remains as one of the most cardinal approaches in the Pharmaceutical industry. Yet, with the on-site monitoring being a huge expense, the medical sector requires another more efficient process. A risk-based monitoring, then, is just what is needed in this situation.
The risk-based monitoring approach allows for the identification of risks at individual sites. But this is not all. It is also a way of assigning a range of monitoring resources which will serve to take into closer consideration the protection of patents as well as data quality risk. Unquestionably, this sort of monitoring presents far more advantages than the full on-site monitoring. In order to specify it, we will have to compare these two tools. When we cut the distance between them and put them next to one another, the very first thing that strikes our attention is the impression that the on-site monitoring is extremely costly and way too time-consuming.
Rapidly turning into a thing of the past, the on-site monitoring is a “no-no,” especially when we want high-standardized procedures. On the other hand, the other type of “tracking” or “observing” is updated, more centralized, safer and, undoubtedly, more operative. Embracing a real-time overview of data in combination with excellently-established risk detection and mitigation tactics, the result is that of the most efficacious technique for handling a clinical programme.
Determining a stable position and becoming an exciting opportunity for the clinical progress, the risk-based monitoring can help avoid protocol deviations; data which is not being reported or which is being inaccurately reported; and finally, fraud and fabrication of data. Part of the benefits of this monitoring strategy is that, first and foremost, it offers enhanced data quality. What is more, the risk-based monitoring cuts the price tag of clinical trials and reduces the overall monitoring cost.
Similarly, the well-acclaimed independent consultant and trainer Jane Tucker has pointed out that in order to have an optimally working company which delivers the best possible results, the industry has to incorporate exactly such risk-based monitoring. More precisely, according to her, by using such approach; “your limited resources can be used where you’re sure they will deliver the greatest benefit, whether it’s to the study, the site, the drug development programme etc.”
From an organization’s point of view, it is of a great importance to have ideally functioning methods that will deliver the most desirable outcomes. With the implementation of risk-based monitoring approach, the paradigm of how experts monitor clinical trials is changed for the better. Thanks to it, there is not only improved quality of data but also reduced cost of monitoring and trials too.
On a side note, Astra Nova is going to carry out two webinars, one on Clinical Trials Risk Management and one on Risk-Based Monitoring, in May 2015, with the trainer being no other but the RBM expert Jane Tucker that was mentioned above. Everyone who is interested in learning more about this kind of monitoring is welcome to attend and for more info, follow our blog and we will keep you updated!
