Myths surrounding the use of synthetic control arms in clinical trials: Part 2
In Part 2 of this four-part blog series, we bust another myth surrounding synthetic control arms (SCAs) used in clinical development. Synthetic control arms leverage real world, observational and other historical data to demonstrate the positive effects of a new therapy or treatment, without the need to use a placebo or standard of care as a control.
In a recent Cytel webinar on this topic, Louis Dron, Senior Director at Cytel, explains how synthetic controls are assumed to be a quick way of getting your drug to the market. This is an incorrect notion, and in this blog, I briefly list the reasons as explained by Louis in the webinar.
Myth 2: Synthetic controls are quick
SCAs are often compared to the traditional randomized or non-randomized controlled clinical trial which can take several years to complete. Especially in cases like rare diseases, the trial duration can be particularly long. But if that is our benchmark, trials using SCAs can certainly be a lot quicker compared to the traditional clinical trials for rare diseases.
On the other hand, the SCA projects can be fairly substantial in terms of resourcing and the time which is required to undertake them. Especially, if we consider the context in which a synthetic control is used, for example, in regulatory submission or reimbursement submission, the associated timelines can vary. When we think of a regulatory submission, we aim for an evidentiary standard which is very high.
Critical elements of SCA construction occur long before a single data point is analyzed. Statisticians must apply their insight to choose vendors, engage literature reviews, and coordinate stakeholders from clinical, statistical and market-access. Getting these groups together can take a surprising amount of time.
Another factor that needs significant consideration is which data source to use, especially when you are fortunate enough to have more than one option available.
Finally, you need to decide how to tie-in all these factors together when you speak to the regulatory bodies. You will have to come up with a clear regulatory narrative when SCA is involved since you ruled out all the other alternatives.
In conclusion, can we say SCA is quick? In a traditional controlled trial set up, in a rare population, SCA is probably quicker. But it is worth mentioning that these are not quick fix solutions to data challenges which come up.
Click on the button to watch the complete webinar.
Read the first part of this series, here.
About the Author of Blog:
Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.