Scientific advisory boards (SABs) are an important part of the governance framework for digital real-world studies. These studies are conceptualized and designed with the purpose of collecting longitudinal data on the real-world experiences of patients, or caregivers of patients, living with certain rare diseases. In developing these studies, we want to ensure that the data we capture is pertinent to patients, generated in an academically rigorous manner, and ultimately valuable for drug discovery and development. To do this, we rely on the invaluable input of experts across these domains.
In studies where SABs are involved, the boards are constructed to comprise disease-specific clinical experts and patient advocacy group (PAG) representatives from each of the study countries, where feasible. The SAB plays an important role in guiding the development and conduct of the digital registries, from input at the earliest stages of study design through to advice on data analysis and resulting publications.
Benefits of SAB guidance for digital registries
- Ensures effective operational management of the study
- Ensures that the study operates in the best interests of participants
- Ensures that the study operates to the highest levels of academic rigor.
Responsibilities of the SAB
The design of the SAB will depend on the study. An effective approach is to form sub-committees of members with specific interests, who can take more prominent roles in certain aspects of the study. Members are kept up-to-date with developments through newsletters and are brought together in regular meetings to discuss the progress of the study as well as plans for its future.
Depending on the study, responsibilities of the SAB could include:
- Guiding study evolution
- Advising on study app design and content
- Providing input for participant-facing materials
- Communicating with the participant cohort
- Raising visibility of the study with the wider participant community
- Advising on the publications and analysis strategy
- Reviewing publications
- Acting as a decision-making body for data access requests.
An SAB is especially beneficial as its members can provide valuable external perspective and constructive criticism in the design and development of a digital registry. The inclusion of an SAB does, however, necessitate expenditure of time and resources by the members themselves as well as by the study investigators. It is therefore essential to establish an effective means of implementing their involvement, to derive the most benefit from their expertise.
At Vitaccess, we have a proven record of successfully implementing SABs as a part of the governance framework for our studies. If you are interested in learning more about our studies or to find out how we can work together, get in touch at firstname.lastname@example.org.
By Fatemeh Amini