beatriz s lima
Research Institute for Medicines (iMed.ULisboa)
Specialty Chief Editor
Regulatory Science, the science behind regulatory requirements for the development of medicinal products, has gained increasing recognition over the past years as a unique scientific discipline.
The need to regulate the principles and requirements for the development and human use of medicinal products has been mainly triggered by some fatal accidents with sulfanilamide elixir (USA, 1937), thalidomide malformations (Europe, 1957) and the more recent catastrophic failures with the CD28 antibody (TGN1420, 2005). The two latter cases in particular have clearly highlighted the need for continuous updating of regulatory guidelines based on the scientific advances behind each developing medicinal product or therapeutic class/target. The latest clinical trial accident with BIA 10-2474, (France, 2016) point towards the same direction.
Recent scientific advances in human genome decoding and other technological advances have helped researchers design targeted molecules that are modulated according to individual target attributes in diseases such as cancer and others. Additionally, the modeling and simulation capabilities as well as the emerging capacities to record, stratify and bank human samples, patient information (such as electronic health records), etc. is putting into reflection and discussion new approaches for preclinical and clinical studies as well as the early anticipation of models allowing the rationale and cost effective use of the innovative medicines to make it possible for patients and society to access innovation.
Clearly, the flow and accumulation of knowledge on medicines, diseases, and patient-specific attributes, can only be efficiently used for accelerating innovation if some common principles and strategies are shared by the multiple stakeholders involved in the process. The science and knowledge behind those principles constitute the basis of Regulatory Science.
Regulatory Science is focused on the development of policy tools and regulatory standards that would facilitate decision making for regulatory authorities. The ultimate goal is to improve the efficiency and accuracy of these decisions and thereby foster innovations and progress in medicine and patient care.
Regulatory Science is a transversal discipline based on the knowledge generated by the pharmaceutical industry, academia, regulatory agencies, health institutions and health technology systems. Providing a scientific basis for regulatory policies is necessary not only for efficiency but also for improved protection of the general public.
Research findings are routinely used to assess and diminish human health risks associated with the adoption of a new drug, approach or treatment. Conducting and sharing research on new tools and approaches is key to informing regulatory science and impacting its future directions. To better serve the community, research should be published as soon as possible and made readily available to regulators and other stakeholders. A new section of Frontiers in Medicine, Regulatory Science, invites authors to submit their manuscripts dealing with regulatory science aspects in the field of medicine. The key focus areas for the Regulatory Science section of Frontiers in Medicine are the tools that cover the regulation of pharmaceutical medicine, patient treatments and medical devices.
Frontiers in Medicine is member of the Committee on Publication Ethics.
PubMed, PubMed Central (PMC), Scopus, Google Scholar, DOAJ, CLOCKSS, Web of Science Science Citation Index Expanded (SCIE)
All published articles receive a PMCID
Regulatory Science welcomes submissions of the following article types: Brief Research Report, Case Report, Clinical Trial, Correction, Editorial, General Commentary, Hypothesis & Theory, Methods, Mini Review, Opinion, Original Research, Perspective, Policy Brief, Policy and Practice Reviews, Review, Study Protocol, Systematic Review, Technology and Code.
All manuscripts must be submitted directly to the section Regulatory Science, where they are peer-reviewed by the Associate and Review Editors of the specialty section.
Frontiers' philosophy is that all research is for the benefit of humankind. Research is the product of an investment by society and therefore its fruits should be returned to all people without borders or discrimination, serving society universally and in a transparent fashion.
That is why Frontiers provides online free and open access to all of its research publications. For more information on open access click here.
Frontiers is fully compliant with open access mandates, by publishing its articles under the Creative Commons Attribution licence (CC-BY). Funder mandates such as those by the Wellcome Trust (UK), National Institutes of Health (USA) and the Australian Research Council (Australia) are fully compatible with publishing in Frontiers. Authors retain copyright of their work and can deposit their publication in any repository. The work can be freely shared and adapted provided that appropriate credit is given and any changes specified.
Under the Frontiers Conditions for Website Use and the Frontiers General Conditions for Authors, authors of articles published in Frontiers journals retain copyright on their articles, except for any third-party images and other materials added by Frontiers, which are subject to copyright of their respective owners. Authors are therefore free to disseminate and re-publish their articles, subject to any requirements of third-party copyright owners and subject to the original publication being fully cited. The ability to copy, download, forward or otherwise distribute any materials is always subject to any copyright notices displayed. Copyright notices must be displayed prominently and may not be obliterated, deleted or hidden, totally or partially.
Each Frontiers article strives for the highest quality, thanks to genuinely collaborative interactions between authors, editors and reviewers, who include many of the world's best scientists and scholars. Frontiers is well aware of the potential impact of published research both on future research and on society and, hence, does not support superficial review, light review or no-review publishing models. Research must be certified by peers before entering a stream of knowledge that may eventually reach the public - and shape society. Therefore, Frontiers only applies the most rigorous and unbiased reviews, established in the high standards of the Frontiers Review System. Furthermore, only the top certified research, evaluated objectively through quantitative online article level metrics, is disseminated to increasingly wider communities as it gradually climbs the tiers of the Frontiers Tiering System from specialized expert readership towards public understanding.
Frontiers has a number of procedures in place to support and ensure the quality of the research articles that are published:
Only leading experts and established members of the research community are appointed to the Frontiers Editorial Boards. Chief Editors, Associate Editors and Review Editors are all listed with their names and affiliations on the Journal pages and are encouraged to publicly list their publication credentials.
Associate Editors oversee the peer-review and take the final acceptance decision on manuscripts. Editorial decision power is distributed in Frontiers, because we believe that many experts within a community should be able to shape the direction of science for the benefit of society.
Submitting authors can choose a preferred Associate Editor to handle their manuscript, because they can judge well who would be an appropriate expert in editing their manuscript. There is no guarantee for this preference of choice, Associate Editors can decline invitations any time, and the handling Associate Editor can also be over-ridden by the Chief Editor before she/he is invited to edit the article or at any other stage.
Associate Editors are mandated to only accept to edit a manuscript if they have no conflicts of interest (as stated here and in their review invitation and assignment emails).
Should it become clear that the Associate Editor has a conflict of interest or is unable to perform the peer-review timely and adequately, a new Associate Editor can be assigned to the manuscript by the Chief Editor, who has full control to intervene in the peer-review process at any time.
The Associate Editor initially checks that the article meets basic quality standards and has no obvious objective errors.
The Associate Editor can then personally choose and invite the most appropriate reviewers to handle the peer-review of the manuscript, including Review Editors from the board or external reviewers.
The Associate Editor is aided in this by the Frontiers Collaborative Review Forum software and interface, which suggests the most relevant Review Editors based on a match between their expertise and the topic of the manuscript. Associate Editors can however choose any reviewer they deem adequate.
After a certain time frame and if no reviewers have in the meantime been assigned to the manuscript, the Frontiers platform and algorithmic safety-net steps in and invites the most appropriate Review Editors based on constantly updated and improved algorithms that match reviewer expertise with the submitted manuscript.
Review Editors and reviewers are mandated to only accept to review a manuscript if they have no conflicts of interest (as stated here and in their review invitation and assignment emails).
Frontiers algorithms are constantly fine-tuned to better match Review Editors with manuscripts, and additional checks are being coded into the platform, for example regarding conflicts of interest.
Should it become clear that a particular reviewer has a conflict of interest or is unable to perform the peer-review timely and adequately, he or she shall be replaced with an alternative reviewer by the Associate Editor or the Chief Editor, who will be alerted and has full control to intervene into the peer-review at any time.
In the Independent Review Stage the assigned reviewers perform an in-depth review of the article independently of each other to safeguard complete freedom of opinion.
The reviewers are aided by an online standardized review questionnaire – adopted to article types – with the goal to facilitate rigorous evaluation according to objective criteria and the Frontiers Review Guidelines.
The Associate Editor assesses the reviews and activates the “Interactive Review” – informing the authors of the extent of revisions that are required to address the reviewers’ comments, and starting the Interactive Discussion Forum where authors and also the reviewers get full access to all review reports.
Manuscript and review quality at this stage are enhanced by allowing authors and reviewers to discuss directly with each other in real-time until they reach consensus and a final version of the manuscript is endorsed by the reviewers.
Reviewer identity is protected at this stage to safeguard complete freedom of opinion.
Reviewers can recommend rejection at this stage if their requests to correct objective errors are not being met by the authors or if they deem the article overall of insufficient quality.
Should a dispute arise, authors or reviewers can trigger an arbitration and will alert the Associate Editor, who can assign more reviewers and/or bring the dispute to the attention of the Chief Editor. The Associate Editor can also weigh in on the discussion and is asked to mediate the process to ensure a constructive revision stage.
The decision to accept an article needs to be unanimous amongst all reviewers and the handling Associate Editor.
The names of the Associate Editor and reviewers are disclosed on published articles to encourage in depth and rigorous reviews, acknowledge work well done on the article and to bring transparency and accountability into peer-review.
Associate Editors can recommend the rejection of an article to the Chief Editor, who needs to check that the authors’ rights have been upheld during the peer-review process, and who can then ultimately reject the article if it is of insufficient quality, has objective errors or if the authors were unreasonably unwilling to address the points raised during the review.
Chief Editors can at any stage of the peer-review step in to comment on the review process, change assigned editors, assign themselves as a reviewer and even as the handling editor for the manuscript, and therefore have full authority and all the mechanisms to act independently in their online editorial office to ensure quality.
Only leading researchers acting as Associate Editors, who are not part of Frontiers staff, can make acceptance decisions based on reviews performed by external experts acting as Review Editors or reviewers. None have a financial incentive to accept articles, i.e. they are not paid for their role to act as Associate or Review Editors, and any award scheme is not linked to acceptances of manuscripts.
Chief Editors receive an honorarium if their specialty section or field reaches certain submission levels. However, this honorarium is based on the total number of submitted articles during a calendar year, and not the number of accepted articles. Therefore they also have no financial incentive to accept manuscripts.
The Frontiers platform enables post-publication commenting and discussions on papers and hence the possibility to critically evaluate articles even after the peer-review process.
Frontiers has a community retraction protocol in place to retract papers where serious concerns have been raised and validated by the community that warrant retraction, including ethical concerns, honest errors or scientific misconduct.