Regulatory Science and Meta Science as Components of Regulation of Medical Products and Practices

Translating research into improved patient care practices and products assumes that the underlying and cumulative research is valid and reliable, with evidence of reproducibility. Increasing evidence estimates that twenty percent or higher, of research in some fields may not meet these quality criteria. If verified, such a deficit can delay progress toward the required scientifically robust evidence base and can constitute a largely undetected source of research participant/patient harm. Identifying individual scientific papers and the portion of literature so affected and retracting and/or correcting the scientific record has been extremely limited. Practices/tools to do so are emerging and will eventually become a routine element of managing bodies of scientific knowledge to an adequate level of scientific quality.

The purpose of this research topic is to link two bodies of knowledge essential to quality health care research, practices, and products – regulatory science/affairs and meta science (the study of science). Merging perspectives from regulatory science and meta science is essential to assure that the evidence base on which regulations are built and evaluated is scientifically rigorous, no matter the regulatory objective and the kind of research it prioritizes. This effort is central to scientific integrity.

The US FDA defines regulatory science as the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA regulated products, and regulatory affairs as utilizing regulatory science to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA regulated products. Likewise, EMA defines regulatory science as the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision making throughout the life cycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools. But beyond the specific field of drug/device regulation, the notion of regulatory science is also applied more broadly to refer to regulatory policies addressing methodological and ethical standards in science – think RECs and research misconduct regulations, among others. Meta science produces evidence of the quality of scientific practice and of the evidence base which has been produced. An example is the Cochrane systematic review. But Meta science may not address the normative judgment on evidentiary requirements necessary to protect human health and the environment.

Submission of articles (which must be focused on quality and accuracy of the underlying data) should cover topics such as (but not limited to):

- How quality of evidence affects risk assessments by regulators including RECs
- Contribution of meta-science to decrease lag time for safe/effective translation of regulated products/practices into patients
- Quality of real-world evidence necessary to support regulatory decisions
- Sufficient level of reproducibility of underlying science necessary to support regulatory decisions
- Quality of the meta science base to support regulation at various stages of the emergence of new technologies and old ones not under control
- Research security in the biomedical sciences
- Emerging methods for assuring high regulatory standards, i.e. natural language processing and other advanced analytics
- Analysis or regulatory successes and failures
- Experimental testing of regulations before full implementation
- Quality of shared data requirements for interoperable devices
- Democratization of goals to be achieved in regulatory science including in distribution of evidence and of errors
All should address how the merging of regulatory science and meta science approaches could significantly improve quality of regulated products/practices