Pragmatism, dynamism and flexibility in research and clinical practice

Research findings need to be communicated and disseminated for them to be useful to society, and therefore scientists have an obligation to publish their results. Thousands of articles are published every day, and submissions to most mainstream journals are exponentially increasing. Despite a rigorous peer-review process, scientific publishing is not without flaws and it is associated with several biases. The ultimate aim of all biomedical/ health sciences research is to contribute to the improvement in understanding, diagnosis, management and prevention of diseases. However, only a small number of publications have a direct impact in achieving such goal. Therefore, pragmatism is desirable to avoid unnecessary use of resources and transparency is required to reduce research waste. Although it has become much easier to find information due to easy availability and access to online resources, researchers are continuously faced with the challenges of keeping up to date, not only with the advances in their chosen field of interest, but also with the ever growing requirements set by their institutions, funders, governments and international regulatory bodies and conventions. Although preparing a research protocol, obtaining funds, conducting research adhering to ethical principles and reporting findings in a transparent and honest manner still remain the main tasks, researchers today spend a substantial amount of their time filling forms and checklists. Some researchers see this as a hindrance to their work and productivity. Others may find it difficult to keep up with changing guidelines, rules and requirements. When a research report based on several years of hard work is rejected outright, for example, for the protocol not being registered in a clinical trials register, – it is easy to create unhappiness among the authors, occasionally even provoking some hostility towards the journal editors. However, journals have also an obligation to follow the rules and regulations. To improve the quality, clarity, completeness and transparency in health research reporting most prestigious medical journals today require authors to follow relevant guidelines. Fortunately, most of these guidelines are available at http:// www.equator-network.org, including an updated catalogue of reporting guidelines for health research in tabulated form. The guidelines on conducting and reporting biomedical research have been evolving with time. Perhaps the most significant event was the World Medical Association (WMA) Declaration of Helsinki outlining ethical principles for medical research involving human subjects in June 1964 (1). Minimizing risk, avoiding harm, taking care of confidentiality, obtaining ethics committee approval and informed consent from the participants have been the guiding principles from the very onset. The declaration has been amended several times (latest in 2013), and from 2008 onwards it requires that “every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. ” The World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE) also support clinical trial registration requirement. Several registers exist today in six continents and some publically available are listed on the ICMJE website. Examples are: ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP), the ISRCTN Registry, EU Clinical Trials Register, Australian New Zealand Clinical Trials Registry (ANZCTR), Pan-African Clinical Trial Registry. Some countries such as Brazil, China, Cuba, India, Iran, Japan, Korea, Netherlands and South Africa have their own national registries. Recent efforts have been directed towards helping scientists to improve their research protocols and quality of reporting. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) is an international initiative launched in 2013 (2) to improve the quality of clinical trial protocols by defining an evidence-based set of items. Better reporting of interventions: template for intervention description and replication (TIDieR) is a checklist and guide that was published in 2014 (3). The importance of registering a clinical trial in an appropriate register, publishing the protocol before starting to recruit participants, and reporting the interventions in sufficient detail to allow their replication by others, cannot be over-emphasized. The WMA Declaration of Helsinki also states “the welfare of animals used for research must be respected. ” Use of animals in biomedical research must be ethically justified and approved by appropriate authorities. Prospective registration of preclinical studies is desirable, but whether this burden is justifiable given the short life cycle and duration (usually months rather than years) of preclinical trials remains debatable. The Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines were introduced in 2010 to help improve reporting standards (4). However, their implementation appears to have been slow. Gender bias in animal research created by preferred use of male animals is another issue that needs addressing in future. The Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies (CAMARADES) initiative has been launched as an organization supporting researchers involved in meta-analyses of experimental animal studies. It is clear that the same standards which apply to clinical trials should also be applied to systematic reviews, including registration and publication of protocols. To minimize biased and/or incomplete reporting Quality of Reporting of Meta-analyses (QUOROM) guidelines were published in 1999, and were succeeded by Preferred Reporting Items for Systematic reviews and