Regulatory Expectations Research Articles

Valuable Learning, Unwelcome Assessment: What LLB and JD Students Really Think About Group Work

This article contributes to current debates about the appropriate role of group work in legal curricula by providing insights into the attitudes of Bachelor of Laws ('LLB') and Juris Doctor ('JD') students towards such tasks. It begins by reviewing arguments for incorporating group work in legal education, both as a result of the recognition of its educational benefits, and as a response to increasing regulatory expectations regarding student collaboration skills. The article then reports the findings of a UNSW Law School Student Assessment Survey designed to determine how law students perceive group work and its assessment in law. One of the most striking findings is that many of the law students surveyed recognise and appreciate the learning and skills development benefits of group tasks, but are resistant to summative assessment of group work. Moreover, there are marked differences in attitude between LLB and JD students, and across year cohorts within those degrees. These findings suggest that further thought needs to be directed towards the specific purposes underpinning the choice of group work as a pedagogical tool, and assessment that is congruent with those purposes, taking into account the varying needs and experiences of different cohorts of students. The article concludes by considering whether meaningful group work can exist without summative assessment.

Oncology labels with clinical outcomes data since the final PRO guidance.

88 Background: FDA released draft Guidance on Patient-Reported Outcomes (PROs) in 2006 and finalized it in 2009. The Guidance applies equally to clinician and observer outcomes (ClinROs, ObsROs; collectively, clinical outcome assessments - COAs), and defines regulatory expectations for COA instruments in pivotal clinical trials and the inclusion of COA data in approved labeling. The purpose of this review was to survey labels for oncologic drugs approved in the three years since the “PRO Guidance” was finalized and to characterize any COAs in these labels. Methods: CenterWatch maintains a list of FDA approved drugs following definitions established by the Tufts Center for the Study of Drug Development, including only drugs or NMEs newly approved by the FDA Center for Drug Evaluation and Research. From 2010 through 2013, 45 oncologic drugs were approved by the FDA. The labels and other information from the Drugs@FDA website were reviewed. Results: Few of the approved labels included any reference to COAs or data collected using PROs, ClinROs, or ObsROs. Several (e.g., carfilzomib) had clear statements indicating approval for the product was based on a predefined response rate rather than “improvement in survival or symptoms.” The exceptions are fentanyl tablets and spray, and abiraterone, all with PRO data on pain. The number of PROs in the labels reviewed was low, but the trend suggests that products reviewed by Divisions outside the Office of Hematology and Oncology Products were more likely to have a PRO. Abiraterone was an exception as it was reviewed by Oncology Products I and included patient reported pain. Conclusions: There are several explanations for the low rate of COAs in oncology labels, e.g., oncology trials tend to be unblinded. The FDA has stated that open label designs cannot support PRO claims. Yet there is still a heavy reliance on outcomes such as progression free and overall survival. Three labels were identified with PRO data on pain, two of which were specifically indicated for pain rather than tumor control. This review suggests there are opportunities for sponsors and the FDA to increase the degree to which the patient’s voice is heard during the regulatory decision process, particularly, in programs reviewed by the oncology divisions.

Understanding the Food Safety Modernization Act and the role of quality practitioners in the management of food safety and quality systems

PurposeThe purpose of this paper is to explore the key requirements of the Food Safety Modernization Act (FSMA), recently passed by the US Congress to safeguard the nation's food supply, and to ascertain the role of quality professionals in the management of food safety and quality systems for food facilities.Design/methodology/approachSince genesis of the Act emanates mainly from the recent upsurge in food disease outbreaks in North America, key lessons learnt from the 2008 Listeriosis outbreak in Canada were reviewed. Thereafter, a case study of developing a food safety and quality management system for a “very low risk facility” – i.e. a third party warehouse – was considered. Finally, potential connections between the sections of the FSMA and roles of various quality practitioners were discussed.FindingsRecent study at the third party logistics warehouse revealed developing and implementing pre‐requisite programs (PRPs), i.e. mainly operational and physical controls, had a positive impact on the food safety and quality management system (FSQMS). Hence, quality practitioners may focus on PRPs to enhance compliance to FSMA requirements.Practical implicationsFood production, processing, packaging and/or distribution companies that export their products to the USA, as well as enterprises requiring preventive controls to ensure food safety and quality, can greatly benefit from the services of quality practitioners. Other key inputs the practitioners provide to the FSQMS include costs reduction, value addition, defects prevention, process control, maintenance and improvement.Originality/valueThe paper closely studies quality practitioners’ perspectives towards meeting or even exceeding the new food safety regulatory expectations in food‐related institutions.

Information privacy and correlates: an empirical attempt to bridge and distinguish privacy-related concepts

Privacy is one of the few concepts that has been studied across many disciplines, but is still difficult to grasp. The current understanding of privacy is largely fragmented and discipline-dependent. This study develops and tests a framework of information privacy and its correlates, the latter often being confused with or built into definitions of information privacy per se. Our framework development was based on the privacy theories of Westin and Altman, the economic view of the privacy calculus, and the identity management framework of Zwick and Dholakia. The dependent variable of the model is perceived information privacy. The particularly relevant correlates to information privacy are anonymity, secrecy, confidentiality, and control. We posit that the first three are tactics for information control; perceived information control and perceived risk are salient determinants of perceived information privacy; and perceived risk is a function of perceived benefits of information disclosure, information sensitivity, importance of information transparency, and regulatory expectations. The research model was empirically tested and validated in the Web 2.0 context, using a survey of Web 2.0 users. Our study enhances the theoretical understanding of information privacy and is useful for privacy advocates, and legal, management information systems, marketing, and social science scholars.

Presence and hazards of nutrients and emerging organic micropollutants from sewage lagoon discharges into Dead Horse Creek, Manitoba, Canada

Nutrient enrichment and loadings of pharmaceuticals and agrochemicals into freshwater systems are common concerns, especially for water bodies receiving wastewater inputs. In the rural communities of Morden and Winkler of Manitoba, Canada, sewage lagoons discharge their wastewater directly into Dead Horse Creek, a small tributary of the Red River that empties into Lake Winnipeg. This lagoon approach to managing rural wastewaters is common across the North American Prairies. Therefore, this study aimed to assess the hazards of lagoon treatment releases at this model site. This was done by characterizing the nutrients, organic micropollutants (i.e., pesticides, pharmaceuticals) and standard water quality parameters in the creek prior to and following lagoon discharge events over a number of years (2009–2011). Measured concentrations of nutrients were compared to regulatory expectations and micropollutants were assessed using hazard quotients. As expected, concentrations of nitrogen and phosphorus species were greatest in sites downstream of the sewage outfall immediately following discharge events. Pharmaceutical and agricultural chemicals were detected at concentrations between 0.5 and 90ng/L. Detection frequencies and concentrations matched typical use patterns. Those compounds used predominately for human medicine were detected at downstream sites following discharge events, while those used in an agricultural setting were detected at relatively consistent levels over time at sites both upstream and downstream of the outfall location. Hazard quotients calculated for micropollutants of interest indicated minimal toxicological risk to aquatic biota in the creek, with only erythromycin and diazinon presenting a potential concern to aquatic algae and invertebrates. Concentrations of nutrients exceeded Canadian guideline thresholds during release, but returned to background levels once discharges ceased. Therefore, it is advisable that wastewater treatment and management strategies such as constructed wetlands and/or staggered releases be used in order to minimize the hazard posed by nutrient pulses in Dead Horse Creek and other similar systems.

Managing Scientific, Technical and Regulatory Innovation in Regulated Bioanalysis: A Discussion Paper from The European Bioanalysis Forum

On 12-13 June 2012, the European Bioanalysis Forum hosted its third Focus Meeting in Brussels (Belgium). At the meeting, a panel discussion was held on the hurdles that the bioanalytical community encounters when adopting new technologies or managing regulated bioanalysis expectations around emerging technologies. Over the last few years, the industry has seen many new technologies maturing. As they became available, the bioanalytical scientist has observed that implementing these technologies in the regulated environment has become increasingly challenging. For one, scientific developments and regulatory expectations may not go hand in hand. At the same time, the pharmaceutical industry has become increasingly risk averse in their response to these real or perceived higher expectations in regulated bioanalysis. As a downstream consequence, the potential result of overinterpretation of guidance or occasional widespread and premature implementation of responses to health authority inspections, industry may be contributing significantly to raising the bar on some processes related to day-to-day practices in the bioanalytical laboratory. Last but not least, with the community being satisfied with the performance of the current tools, potential complacency can be observed in the regulated bioanalytical community because existing technologies, such as LC-MS/MS and ligand-binding assays, have served and still are serving them extremely well. Hence, the question 'what's next after LC-MS/MS or ELISA?' is not resonating with many scientists as pertinently compared with 'What's next after RIA, GC or LC-UV?', which was the key question in the 1990s, certainly in the context of an increasing effort needed to validate these new tools. With this article, the European Bioanalysis Forum aims to stimulate an open dialogue between all stakeholders in regulated bioanalysis to positively influence how we balance science, process and regulations in day-to-day work. This discussion should facilitate the evaluation and the subsequent implementation of innovative techniques for the benefit of the patient, while stimulating our community to raise the bar on added-value science, but at the same time removing the bar on processes with limited or no added value.

Community engagement of petroleum company: getting the right fit in Sudan

This case concerns the community engagement practice of JOC Petroleum (JOC), a company that has been operating in the south of Sudan since year 2001. In 2011, the newly formed Republic of South Sudan declared ‘Development and Equitable Sharing of Wealth Guiding Principles’ for all its oil and gas investors, through which community development projects are now considered as a legal requirement. Such development has prompted JOC to review its community engagement practices, particularly in terms of its compliance with the present regulatory and societal expectations. This case concerns transformation in community engagement practices as a response towards a regulatory change in order to sustain the organisation’s legitimacy.

Application of two‐dimensional selective‐TOCSY HMBC for structure elucidation of impurities in mixture without separation

In the pharmaceutical industry, regulatory expectations driven by patient safety considerations make structure elucidation of impurities at levels greater than 0.1% in the active pharmaceutical ingredient (API) of primary interest. Impurities can be generated from isomers in starting materials, or produced from different process steps toward the final API. Proton peaks belonging to different impurities could be potentially identified in the one-dimensional (1)H NMR spectrum, when evaluated in combination with two-dimensional (2-D) COSY and HSQC data. However, in 2-D HMBC data, correlation responses from different impurities may overlap with those from the major component, causing uncertainty of long-range proton to carbon correlations and quaternary carbon assignments. This observation prompts us to design the 2-D selective-TOCSY HMBC experiment to distinguish responses from different impurities in mixtures to obtain 2-D NMR data for each impurity, thus eliminating the use of a chromatographic isolation step to obtain material for NMR analysis. This methodology is demonstrated for structure elucidation of impurities ranging from 8.2% in the raw material to 0.4% in the API in this study, and would be particularly useful for industrial samples in which the solubility and availability of material are not an issue.

Characterizing CO2 storage reservoirs and shallow overburden for above‐zone monitoring in Texas Gulf Coast EOR fields

AbstractEnhanced oil recovery (EOR) through carbon dioxide (CO2) injection provides an excellent opportunity for commercial sequestration of anthropogenic CO2. A fluvio‐deltaic, deep‐seated salt dome and a strand‐plain, roll‐over anticline from the Gulf Coast region are currently under investigation for the design and implementation of monitoring, verification, and accounting (MVA) plans, in coordination with the commercial surveillance of independent, large‐volume (>1 million ton/year) CO2‐EOR operations. Characterization with wireline logs demonstrates the vertical extent and areal continuity of reservoir sands and geometries of faults that offset the reservoir. To develop the monitoring plan, we focused on several elements: (i) characterization of the zones above the confining unit for above‐zone pressure monitoring, (ii) collection and development of input data for ‘quick‐look’ dynamic modeling of CO2 plume extent and pressure elevation, and (iii) identifying intersections of faults with wellbores in intervals above the regional confining unit for thermal monitoring. Other uncertainties addressed during characterization are the upper extent of faults and the juxtaposition of layers to assess the potential for cross‐fault fluid migration. Successful use of such techniques for MVA, based on uniting elements of existing regulatory monitoring expectations, would lead to the establishment of commercial best practices for effective and rapid characterization of EOR sites in the Gulf Coast region. © 2012 Society of Chemical Industry and John Wiley & Sons, Ltd

Sarcopenia: What's in a Name?

Changes in medical terminology and disease taxonomy are an inevitable fact of life in medicine. As human innovation brings about new investigative tools and ever more powerful and discriminating analytical methods, inquisitive clinicians and medical scientists uncover novel medical facts at an unprecedented pace. Such new information not only expands the horizons of medical knowledge, it also challenges established concepts, brings into question old dogma, and shifts entrenched boundaries. Oftentimes the evolving understanding of disease processes cannot be fully reconciled with the existing medical knowledge without redefining and reclassifying old syndromes and diseases or, as is the case for entirely new medical conditions, defining and naming them. Sarcopenia illustrates the impact that constantly advancing medical knowledge has on disease definition and taxonomy. Sarcopenia also shows how a lack of clarity or consensus in a medical definition can affect drug innovation: in particular, how such a lack can influence academic research, drug development, and regulatory expectations. The term sarcopenia was coined in the 1990s. Its origin and significance are summarized by Irwin H. Rosenberg in a 1997 article referencing a presentation that he had made on April 17, 1966, in Washington, DC, at a symposium titled “Sarcopenia: Diagnosis and Mechanisms.”1 True to its Greek roots of sarx (“flesh”) and penia (“loss”), the term sarcopenia was coined to describe a decline in muscle mass occurring in the context of aging. Because structure and function are linked by indissoluble bonds, the relevance of sarcopenia has been from the very beginning connected with the notion of agerelated decline in muscle function, including but not limited to impaired ambulation and mobility. If anyone ever needs a visual confirmation of the concept of age-related muscle loss, one only needs to look at the article’s illustration of the difference in muscle size between a 24-year-old and a 64-year-old woman as shown on a magnetic resonance imaging cross-section of the thigh. And if a picture is worth a thousand words, the field of sarcopenia is today worth more than a thousand publications, commentaries, expert opinions, and several periodic expert meetings at national and international levels. Fifteen years later, many of the questions asked in Dr. Rosenberg’s thoughtful article are just as relevant, as are many

Use of Enzymes in the Manufacture of Active Pharmaceutical Ingredients—A Science and Safety-Based Approach To Ensure Patient Safety and Drug Quality

A significant number of marketed pharmaceuticals contain active pharmaceutical ingredients that are manufactured in part using biocatalysis as a key enabling technology. The utilization of biocatalysis is growing due to significant advances in technologies for enzyme discovery, supply, and improvement, as well as an increased focus on applications for chiral drugs and green chemistry. Nevertheless, there still remains a lack of clarity around quality and regulatory expectations when using biotransformations in research and manufacturing, and this lack of clarity can be a barrier to the uptake and adoption of biocatalysis. This commentary will explore and offer some rational, coherent, and achievable strategies for the use of biocatalysis in the manufacture of small molecule active pharmaceutical ingredients (APIs) based on a scientific, risk-based approach to drug quality and patient safety. We also seek to invite other interested parties to contact us with their views to add to the topics discussed here ...

The Governance Role of Audit Committees: Reviewing a Decade of Evidence

Even though audit committees have traditionally been a key component of corporate governance regulation, the last decade has witnessed a greater emphasis on audit committee regulation and a parallel intensification of academic research on the subject. This review synthesizes recent empirical research seeking to investigate various aspects of audit committees’ governance role. The review is structured around current regulatory expectations of audit committees seeking to document the extent to which specific characteristics of good practice influence various components of audit committee effectiveness. It is found that larger and more independent audit committees as well as those with financial expertise are more likely to seek a higher level of external audit coverage and assurance. There is also evidence that more independent audit committees are associated with the purchase of lower levels of non‐audit services from auditors, thereby seeking to preserve the independence of the external audit process. There seems a consensus that more independent audit committees and those with greater accounting/financial expertise have a positive impact on the quality of financial statements. Evidence on the stock market reaction to audit committee issues suggests that investors both welcome the presence of audit committees and react positively when members are appointed with relevant expertise. It is also found that internal auditors view certain audit committee characteristics, specifically independence, expertise and frequency of meetings, as leading to more effective audit committee performance. In summary, therefore, this review documents a significant amount of evidence offering support to current regulations concerning the desired characteristics of audit committees.

Regulatory Forum Opinion Piece*

The immune system has been recognized for decades as a potential "target organ" of toxicity. Immune system activation can result in cytokine release resulting in severe systemic toxicity. Immunosuppression can result in impaired host defense and an increase in opportunistic infection, reemergence of latent infection, poor responses to vaccination, or increased risk of certain cancers. Several regulatory documents have addressed various aspects of immunotoxicity assessments. Nonhuman primates (NHPs) and in particular macaques are often the only relevant species for biotechnology-derived investigational new drugs based on cross-reactivity with human and NHP targets. This article reviews the challenges and opportunities associated with monitoring immune function in NHPs in the context of regulatory expectations. The article emphasizes how a comprehensive assessment of immunotoxicity remains a challenge due to interanimal variability associated with certain parameters (e.g., T-dependent antibody response)and it identifies gaps, such as the stage of development of certain assays (e.g., cytotoxic T-cell function). Despite these challenges, a thorough assessment of target biology-driven theoretical risks, in combination with proper integration of all information from the standard toxicology studies, and the refinement of certain assays should enable proper risk assessment. To this effect, emphasis should be placed on leveraging predictive in vitro assays using human cells.

Radiolabeled mass-balance excretion and metabolism studies in laboratory animals: a commentary on why they are still necessary

The necessity of conducting traditional radiolabeled absorption, distribution, metabolism and excretion (ADME) studies in animals during development of new investigative agents has been questioned in a recent review.We present a compilation of the benefits of such studies in the understanding of the in vivo pharmacological activity and disposition of new drug candidates, including interpretation of preclinical toxicology findings, characterization of circulating metabolites, and determination of principal pathways of clearance. This understanding is valuable in anticipating the human disposition of the drugs and the planning of the clinical development program.Because of new technologies, evolving regulatory expectations, and increased scientific understanding of the disposition of drugs, the traditional design and timing of both animal and human ADME studies should be reviewed. Innovative “fit-for-purpose” studies may well be a better choice in a particular drug development program than a standard animal ADME “package”. However, we submit that, at this time, radiolabeled animal ADME studies still provide a definitive and irreplaceable component of our understanding of the in vivo actions and behaviors of drugs and should continue to be performed prior to the exposure of large numbers of human subjects to investigative drugs.

Poster - Thur Eve - 07: CNSC Update: "What's New in Class II".

The Accelerators and Class II Facilities Division (ACFD) of the Canadian Nuclear Safety Commission (CNSC), is responsible for the oversight of radiotherapy facilities containing Class II prescribed equipment in Canada. This poster will highlight a number of new initiatives that the CNSC has implemented recently that have an impact on radiotherapy facility licensees. The presentation will discuss the recent policy decision to regulate particle accelerators of above 1 MeV. Challenges and progress with respect to the implementation of the policy will be presented. Other initiatives which will be described include: • The new ACFD webspace on the CNSC website, with direct links to relevant information on licensing, compliance and Class II prescribed equipment • The improved structure of the Appendix of Licence Documents that is part of every Class II licence • Updated licence application guides • Changes to Annual Compliance reporting requirements and progress on the ACR-Online initiative • Changes to some regulatory expectations related to medical accelerator facilities • Consolidation of Class II facility licences The poster will also include other initiatives that may be of particular interest to COMP membership.

US FDA Outreach to the Regenerative Medicine Community: Challenges and Opportunities

Advances in the field of regenerative medicine have yielded novel approaches to developing treatments for currently unmet medical needs. The regenerative medicine field is diverse, spanning many research and clinical disciplines; no single society or organization fully represents regenerative medicine. The US FDA maintains an active dialog with a variety of stakeholders to keep abreast of the latest available science, to anticipate regulatory challenges posed by the latest scientific developments and to educate stakeholders about regulatory expectations for product development. The diversity of stakeholders in this field makes this dialog challenging. This article provides an overview of some of the FDA's current outreach activities in this area. The FDA welcomes opportunities to enhance its interactions with the regenerative medicine community.

Interpreting the biological relevance of bioinformatic analyses with T-DNA sequence for protein allergenicity

Global regulatory agencies require bioinformatic sequence analysis as part of their safety evaluation for transgenic crops. Analysis typically focuses on encoded proteins and adjacent endogenous flanking sequences. Recently, regulatory expectations have expanded to include all reading frames of the inserted DNA. The intent is to provide biologically relevant results that can be used in the overall assessment of safety. This paper evaluates the relevance of assessing the allergenic potential of all DNA reading frames found in common food genes using methods considered for the analysis of T-DNA sequences used in transgenic crops. FASTA and BLASTX algorithms were used to compare genes from maize, rice, soybean, cucumber, melon, watermelon, and tomato using international regulatory guidance. Results show that BLASTX for maize yielded 7254 alignments that exceeded allergen similarity thresholds and 210,772 alignments that matched eight or more consecutive amino acids with an allergen; other crops produced similar results. This analysis suggests that each nontransgenic crop has a much greater potential for allergenic risk than what has been observed clinically. We demonstrate that a meaningful safety assessment is unlikely to be provided by using methods with inherently high frequencies of false positive alignments when broadly applied to all reading frames of DNA sequence.

L3.1 The Challenges of Drug-Diagnostic (RX-DX) Co-Development: A Biopharmaceutical Perspective

ABSTRACT There has been a major shift from conventional tumor histology alone to a biologically defined stratified approach that has led to the development of new cancer therapies and improved outcomes for cancer patients. The increasing technological power to interrogate the genome and other biologic processes, combined with sophisticated informatics, will continue to provide new biomarkers for targeted cancer therapies. While these factors are accelerating targeted cancer therapy, there are a large number of practical issues that need to be considered in the context of biopharmaceutical development and the marketing of new therapies that require a companion Dx. A Rx-Dx companion “product “should provide for appropriate therapy decision-making in the context of medical need. The strength of evidence for this typically comes from prospective clinical validation studies. Assay performance that meets technical analytical and classification accuracy criteria (including cut-off determination to define biomarker positive vs. negative) is critical for the prediction strength of the biomarker-endpoint relationship. Value creation is another important consideration for BioPharmaceutical and Diagnostic companies. This can be measured in terms of Rx or Dx development productivity, return on investment, and costs/benefits to the health care system. A Dx product intended to identify patients for a specific Rx therapy is a complex system of procedures, reagents, instruments, software, and algorithms, all of which may comprise the regulated product. A typical Dx development process includes discovery and feasibility research, product development, product verification and validation and regulatory approvals and commercialization. There are different regulatory expectations for Dx products across the world. The BioPharmaceutical company needs to integrate the Dx development and regulatory requirements with that of the Rx development and regulatory requirements. The recent approvals of vemurafenib with its companion cobas V600 mutation test and of crizotinib with its companion ALK FISH DNA probe assay are examples of how this can be achieved. Recognizing and managing the practical considerations, challenges and time required are critical to enabling successful Rx-Dx companion development to achieve the mission of delivering targeted health care to cancer patients.

Regulatory focus, self-efficacy and outcome expectations as drivers of motivation to consume healthy food products

In this paper we apply the principle of Regulatory Focus Theory to investigate the interaction between self-efficacy and outcome expectations on individuals’ intentions to adopt health behaviors. The participants, 959 individuals (Survey 1) and 2400 individuals (Survey 2), reported self-efficacy beliefs and outcome expectations with regard to the consumption of omega-3 supplements and omega-3-enriched food products. We found that the relationship prevention outcome expectations-intention was significantly attenuated at low levels of self-efficacy and strengthened at high levels of self-efficacy, respectively; whereas, the relationship promotion outcome expectations-intention was unaffected by the perceived levels of self-efficacy. The implications suggest that consumers’ motivation to adopt healthy food products, such as omega-3 supplements and omega-3 enriched products, should be encouraged by stimulating promotion outcome expectations. However, when a prevention frame is used, the individuals’ motivation should be significantly enhanced by self-efficacy beliefs.

Review of pain measurement strategies to support product labeling in US regulated clinical trials

Researchers are limited in their ability to substantiate treatment benefit hypotheses for new pain products as it is unclear whether existing instruments meet current US regulatory requirements. The goal of this poster is to evaluate pain product labels approved by the FDA over the past 5 years and describe the measurement strategies that have proved successful in demonstrating treatment efficacy and withstanding regulatory review. A search of the PROLabels database was conducted to identify pain treatments approved in the US since 2006. The measurement strategies used in each are summarized with respect to aspect of pain measured, name of instrument, type of scale used, recall period, frequency of assessment, outcome period, quantitative endpoint, and the data analytic procedure used to guide the interpretation of observed change. Since 2006, the FDA has approved labeling for pain or analgesia indications in n=24 labels. Pain intensity was the most frequent pain-related outcome (n=11) though others were used (eg, pain, pain relief). Single item scales were the most frequently used but others such as the BPI and WOMAC were also employed. With respect to scale type, numeric rating scales, verbal response scales, and visual analogue scales were all observed and both paper and electronic methods were employed. As indication dependent variables, frequency of assessment and outcome period were variable across trials and, therefore, so were the specific quantitative endpoints for pain. Researchers primarily relied upon average difference in pain scores and specifying a priori responder definitions to guide the interpretation of trial results. To meet US regulatory expectations, researchers must substantiate their measurement strategy decisions within the context of FDA guidance. By summarizing salient aspects of successfully employed pain measurement strategies, researchers may better understand how to develop their own measurement strategies that can both evaluate treatment efficacy and withstand regulatory review.