Cytel scientists recently published a new eBook on synthetic control arms and a new scientific primer for the more technically advanced. Our new primer focuses on assessing the validity of data, the validity of methodology, and the modes of analysis and interpretation within this burgeoning field. Each of these is a crucial part of understanding how to make the most impact with a synthetic control. Read our blog to learn more about the eBook and the primer, and register to download both.
Cytel also conducted a webinar on Synthetic and External Controls in Clinical Trials with Dr. Kristian Thorlund, a Professor of Biostatistics at McMaster University and Senior Vice President of Real World Evidence at Cytel. In this webinar, Dr. Thorlund introduces synthetic control arms and discusses the validity of data, results and interpretations. He also answers several questions from the audience around sample size calculations, quality of datasets and use of synthetic controls in various kinds of clinical trials. Click on the button to get free access to the recording and the slides from the webinar.
Single arm trials are emerging as an accepted way of assessing a new treatment intervention. They establish clinical benefit by demonstrating the positive effects of a new therapy or treatment, without the need to use placebo or standard of care as a control. Instead, alternative approaches of establishing the comparison are used; these have become known as external controls or synthetic control arms (SCA) and include approaches leveraging real world data from various sources or evaluations of historical clinical trial data.
Dr. Thorlund goes over scenarios where it is appropriate to use SCA. Like in the case of rare diseases, getting a control group is often difficult and randomizing to control is next to impossible because the disease is rare, and it is challenging to get patients. SCA is also used a fair bit as an internal tool in scenarios where there is difficulty in patient recruitment. This can also be observed in the current pandemic, where we see an excessive demand for patients in over 1000 trials that are going on. There are similar issues in many other disease areas where patient enrollment is difficult as patients are getting better, and it is tough to get representative populations.
Synthetic controls can never really be perfect but there are several cases or success stories where synthetic controls were quite helpful, and they resolved difficult problems in a fairly short period of time. Dr. Thorlund shares two such cases and offers insights on how we can use synthetic controls to save resources, money and time.
Get a deep dive into how synthetic control arms can be useful for your organization by watching the complete webinar. Click the button to get free access to the recording and the slides.