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Registration and Ethics Committee Approval for Observational Studies: Current Status and Way Forward

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Registration and Ethics Committee Approval for Observational Studies: Current Status and Way Forward Registration and ethics committee approval for observational studies: Current status and way forward Namrata Singh and Vasudha Background parency (Figure 1). However, RCTs are Turacoz Healthcare Solutions, Gurugram, India Randomised controlled trials (RCTs) investigate performed under tightly controlled conditions the efficacy of new interventions and are and, thus, their results are limited to the patients considered the gold standard in medical research. in experimental settings. Real-world clinical Correspondence to: They are considered strong evidence in the practice comes up with many different situations Dr Namrata Singh hierarchy of evidence-based medicine (EBM) that might not have been tested in a clinical trial. Director, Medical Services because of their well-defined study designs, There can be a new adverse event, an off-label Turacoz Healthcare Solutions compliance with strict protocols, and trans - indication, a co-morbid condition, or a co- 505, First Floor, Phase V Udyog Vihar, Sector 19 Gurugram, Haryana, India – 122002 –––– Systematic review/Meta-analysis [email protected] +91-9810036125 –––––– Double-blind RCTs Abstract –––––– RCTs Randomised controlled trials (RCTs) have always been recognised as the highest level of –––––– Non-randomised trials evidence in medical research. However, they cannot address the questions that one comes –––––– Cohort studies across in real-world clinical practice. Obser - vational studies can answer such questions as they are based upon real data obtained from –––––– Case-control studies patient healthcare records, medical databases, and registries. Literature review has shown –––––– Case series & Cross-sectional studies that observational studies are as important as RCTs and should be considered when making any clinical decisions. However, there is a lack –––––– Case reports of standard guidelines for registering and reporting observational studies, which may –––––– Editorials & reviews contribute to publication and reporting bias. Furthermore, guidelines differ on the ethical –––––– Animal, in vitro & cell considerations for observational studies. models This article discusses these issues, focusing on the current situation and gaps in the registration, ethics approval, and publication of observ ational studies. Figure 1. Level of evidence in medical research.4 The positions of randomised controlled trials and observational studies in the pyramid of evidence for medical research are shown. www.emwa.org Volume 26 Number 3 | Medical Writing September 2017 | 29 Registration and ethics committee approval for observational studies – Singh et al medication that can change the course of the have been based on observational study results, various guidelines have been published by illness. In such situations, an observational study such as the Data Collection on Adverse Events of scientific and regulatory organisations. The guide - can provide answers to many questions and can Anti HIV Drugs (D:A:D) study. The D:A:D lines identified in the literature along with their supplement the clinical trial in applying the study was conducted in 33,347 HIV-1-infected key objectives are summarised in Table 1.11–20 intervention to the general population.1–4 patients and showed that the risk of heart attack Literature review shows that these guidelines In observational studies, the interventions are increased by 49% and 90%, respectively, with the are not all in agreement on standards of not determined by the protocol and are based on use of didanosine and abacavir. On the basis of observational studies: There was no consensus real-world clinical practices. These studies are these study results, the FDA advised healthcare for 12 out of the 23 elements discussed in the based upon data obtained from patient health - providers to evaluate the risks and benefits of guidelines. This may contribute substantially to care records, health care databases, and registries, HIV antiretroviral drugs, including abacavir and disparities in research and, thus, a low quality of and can be prospective or retrospective in nature. didanosine.10 evidence for patient care decisions, leading to Observational studies can be of various types, poor healthcare outcomes. Moreover, there is a including cross-sectional, case-control, and Ensuring the quality of lack of standards for ethical considerations and cohort studies; however, their main strength lies observational studies: dissemination. Only three out of nine guidelines in the fact that they are more proximate to real- What do the guidelines say? addressed these aspects; however, no actions life evidence.1–3 To ensure the quality of observational studies, were suggested regarding implementation.11 Going beyond randomised controlled trials: Where do Table 1: Guidelines for observational studies observational studies stand? Benson et al compared observational studies Guideline Key objective with RCTs across 19 diverse treatments and 1 Agency for Healthcare Research Quality To identify the minimum standards and best found summary estimates of the treatment effects (AHRQ): Developing a Protocol for practices for designing observational to be similar for both types of studies.5 Further, Observational Comparative Effectiveness comparative effectiveness research studies Concato et al identified meta-analyses of RCTs Research12 and observational studies for five clinical topics 2 Comparative Effectiveness Research To assess the relevance and credibility of and found the summary estimates and 95% Collaborative Initiative: Observational Study observational studies for informed health confidence intervals (CIs) to be similar. For Assessment Questionnaire13 care decision making example, the odds ratio (95% CI) was found to 3 European Network of Centres for Pharma - To consider the important principles when be 0.49 (0.34–0.70) and 0.50 (0.39–0.65), coepidemiology and Pharma covigilance designing and writing a pharma coepidemi - respectively, for RCTs and observational studies (ENCePP) Checklist for Study Protocols14 ological or pharmacovigilance study protocol assessing the effectiveness of the Bacillus 4 ENCePP Guide on Methodological To provide methodological guidance for Calmette-Guérin vaccine against active tuber - Standards in Pharmacoepidemiology15 researchers in pharmacoepidemiology and culosis.6 Furthermore, literature shows that pharmacovigilance observational studies are being used by the 5 United States Food and Drug To provide guidance on good American Geriatrics Society, the Endocrine Administration (FDA) Guidance for pharmacovigilance practices and Society, and various other vitamin D expert Industry: Good Pharmacovigilance Practices pharmacoepidemiologic assessment of groups to make recommendations on vitamin D and Pharmacoepidemiologic Assessment16 observational data regarding drugs supplementation.7 6 Good ReseArch for Comparative To provide a checklist for observational RCTs and observational studies need to be Effectiveness (GRACE) Checklist17 comparative effectiveness studies that are viewed together because their different study rigorous in design to help in decision support designs and methods are crucial to provide as 7 GRACE Principles18 To help decision makers evaluate the quality much information as possible in terms of the of observational research studies of safety, efficacy, and effectiveness of an inter - comparative effectiveness vention.8,9 RCTs might not give accurate answers 8 International Society for Pharma co - To provide guidance on framing research in complex situations, for example the presence economics and Outcomes Research questions and reporting findings for of confounding factors, interventions of long (ISPOR) Good Research Practices for retrospective epidemiologic and health duration, larger patient populations, and use of Retrospective Database Analysis Task Force services research studies concomitant medications. Observational studies Report19 can, and should, be used in such complex 9 Patient-Centered Outcomes Research To provide guidance on various topics, domains to explore the best practices in the real Institute (PCORI) Methodology including formulating research questions, world; however, their findings should be Standards20 data integrity and analysis, data registries, considered with due caution.2,4 and systematic reviews There are instances where FDA decisions 30 | September 2017 Medical Writing | Volume 26 Number 3 Singh et al – Registration and ethics committee approval for observational studies Ethical principles for medical increased and observational studies now patient records.29 By contrast, retrospective research represent about 15% of all studies on studies are excluded from the code of ethics As per the Declaration of Helsinki, medical ClinicalTrials.gov. Around half of these studies approval in Turkey.30 research involves research on identifiable human are from North America (50%), followed by Ethics committee approval of observational material or data and needs to be continuously Europe (20%) and Asia (13%), and 85% are studies has been a topic of great debate. This is challenged to prove the efficacy, effectiveness, or funded by non-industry sources. However, the well illustrated by the differences in opinion in quality of prophylactic, diagnostic, and ther - number of observational studies registered is still the literature. While Orchard (2008) argued that apeutic procedures. The design and results of all considered low, exposing observational studies most observational studies are not ethically clinical
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