CATALYSTS DRIVING SUCCESSFUL DECISIONS IN LIFE SCIENCES QUALITY DOESN T COST IT PAYS! BY DR. JESSICA SANTOS

Transcription

1 CATALYSTS DRIVING SUCCESSFUL DECISIONS IN LIFE SCIENCES QUALITY DOESN T COST IT PAYS! BY DR. JESSICA SANTOS APRIL 2018

2 QUALITY DOESN T COST - IT PAYS! PAGE 2 The volume of data from multiple channels being generated today is unprecedented. What s more, a wide spectrum of healthcare stakeholders including patients, caregivers, healthcare professionals (HCPs), payers and regulators each has their own unique set of requirements for extracting insight from data to benefit their own individual needs. The challenge for practitioners eager to gain insights around data is no longer a lack of data, but rather how to best eliminate the noise to obtain quality data. To gain deeper insights into areas such as awareness, perceptions, expectations, trends, predictions and epidemiology, a sharp focus must be applied to how data is gathered, processed and utilized. This will protect the integrity and trustworthiness of the data and optimize its value in making better clinical and commercial decisions, as well as better treatment decisions for patients. DATA QUALITY IS NOT A LEGAL REQUIREMENT Quality is not a law, and organizations do not have to subscribe to the principles of quality. However, for those that choose to invest in it, putting quality processes in place pays off and often significantly! A commitment to quality attracts customers, generates revenue, and builds and maintains an organization s reputation. However, when it comes to compliance, some regulatory requirements do not always provide clear boundaries. Phrases such as adequate protection, proper safeguarding and reasonable expectation often trigger different interpretations, where some may view it as getaway, while others will see it as an opportunity to shine through quality. And customers notice! After all, quality is what defines an organization. Plus, an organization s global standard of quality will support regulatory compliance. For an organization to fully realize the benefits of a global standard of quality, its commitment to quality must stretch throughout and across its value chain. This requires strict process controls maintained throughout the quality system.

3 QUALITY DOESN T COST - IT PAYS! PAGE 3 ISO THE AUTHORITY ON QUALITY MANAGEMENT

4 QUALITY DOESN T COST - IT PAYS! PAGE 4 The International Organization for Standardization (ISO) is recognized worldwide as the authority on quality management. The ISO Research Standards such as ISO for market, opinion and social research; ISO for access panels; ISO 9001 for quality management systems; and ISO for information security management systems are accepted and, in some cases, required globally. The ISO certification credential is understood to be a mark of quality around the world. Why should you seek certification to the ISO Research Quality Standards? The CASRO Institute for Research Quality (CIRQ) provides a list of key factors: BENEFITS OF CERTIFICATION TO THE ISO RESEARCH QUALITY STANDARDS + + Global Management Provides a tool for managing global offices, multiple project teams, and outsourced suppliers to a level of quality consistent with company protocol. + + Risk Mitigation A documented ISO quality system manages variables and delivers proof of adequate controls including data protection and security addressing U.S. safe harbor, EU and other requirements and client concerns. + + Increased Revenue Studies have shown that ISO certified companies experience increased productivity and improved financial performance, compared to uncertified companies. This is due to less re-work, improved employee production and greater client satisfaction leading to repeat business, especially in industries partial to standardized processes and quality controls. + + Increased Efficiency Companies that go through the implementation of ISO and/or ISO create a Research Process (Quality) Management System and have given a lot of thought to their processes and how to maximize quality and efficiency. Once certified, the processes are established and guidelines put in place for anyone to follow, making training, transitions and trouble-shooting easier. + + Employee Morale and Training Defined roles and responsibilities, accountability of management, established training systems and a clear picture of how their roles affect quality and the overall success of the company, all contribute to more satisfied and motivated staff and ease of training new recruits. + + Supplier Relationships and Control As more processes are outsourced for efficiency and to access data in global markets, supplier relationships and quality control are increasingly critical to producing accurate and actionable data. ISO quality certification requires a company to have procedures in place to ensure that a supplier understands the requirements of the ISO research standards as they relate to the work provided. There must be established agreements and methods for evaluating suppliers. Mutually beneficial supplier relationships are one of the key attractions to certification.

5 QUALITY DOESN T COST - IT PAYS! PAGE 5 THE BENEFITS TO ACHIEVING ISO CERTIFICATION ARE MANY, INCLUDING IMPROVED EFFICIENCIES, INCREASED REVENUE, RISK MITIGATION, AND PROCESS CONSISTENCY. + + Documentation The ISO Research standards require documentation of all processes and any changes, errors and discrepancies. This ensures consistency throughout production and accountability of all staff. This also guarantees traceable records are available in case of errors, omissions or to repeat a study. This is also helpful if staff changes occur on a project. + + Consistency All processes from cost quotations and proposals to client deliverables are defined, outlined and documented, minimizing error. Change management is also documented, ensuring that efficiency is maximized. + + Credential Certification to the ISO standard(s) provides third party proof of your quality commitment. Your company will be differentiated in the marketplace with this unique and respected global credential. IT S ALL ABOUT DATA QUALITY WHAT IS DATA QUALITY? Data quality involves two factors validity and reliability. Validity means that the answers we receive apply to the information we are seeking. Reliability describes the ability of an instrument to demonstrate consistent results, meaning that if we ask the same question multiple times, we should conceivably get the same results, and what we observe shouldn t be an isolated incident. Further, for validity, some questions can be interpreted in different ways by different people. For example, when we ask a subject how do you feel?, are we referring to today, in general, on a scale of one to 10, or with regards to a specific event or person? Thus, answers cannot be generalized. The art of asking the right question is the first step towards validity. Additionally, one way to measure reliability is to split the data randomly into two halves, compare the two sets, and then measure the differences. By repeating this exercise multiple times, we should observe the variance of differences. For measuring unidimensionality of a set of items, as well as to confirm the fact that a sample of items is actually unidimensional, we apply Cronbach s alpha, the most widely used objective measure of reliability. Alpha, developed by Lee Cronbach in 1951 to provide a measure of the internal consistency of a test or scale, is expressed as a number between 0 and 1. In addition, reliability estimates show the amount

6 QUALITY DOESN T COST - IT PAYS! PAGE 6 IMPORTANCE OF DATA QUALITY

7 QUALITY DOESN T COST - IT PAYS! PAGE 7 WHY IS DATA QUALITY IMPORTANT? The simple answer is to allow researchers to trust their data and make informed decisions. That s why bad data is worse than no data at all. Typical questions that researchers will ask for gathering data include: + + Does a given population have certain unmet needs? + + What therapeutic and R&D areas should we be examining? + + What do health consumers/patients need? + + Where should we invest to maximize ROI for the brand? + + How do I effectively position my brand with a target audience and in the market? + + How effective is my product s efficacy and safety profile compared to competitive products? + + Where do I find the best and most reliable data for demonstrating my product s value to regulatory authorities? WHO CAN BENEFIT FROM DATA QUALITY? The simple answer is that everyone benefits from data quality. Researchers in clinical, Health Economics and Outcomes Research (HEOR), Real-World Research (RWR), and Market Intelligence (MI) all need the best data possible for analysis and to inform their internal and external stakeholders to make quality, evidence-based decisions. This includes internal marketing teams that need quality data for business optimization; regulators that need data evidence for drug approval and reimbursement decisions; and the scientific community that needs quality data for publication. HOW DO YOU MEASURE DATA QUALITY? The highest quality data is clinical grade data. This data is collected in a clinical environment and put through stringent validation processes. With clinical data, all audit trials are examined, source data are kept, and verification can include 100 percent back checks. In MI, data quality measurement is different, as opinion can change with data subjects responding to the same question differently on different days. + + How do I optimize my media and communication plans? Without good, quality data all of these decisions will be wrong, investment wasted, and in the worst case scenarios, harm will be done to population health and human lives.

8 QUALITY DOESN T COST - IT PAYS! PAGE 8 VALIDATING AND VERIFYING DATA QUALITY 2018 Kantar Health

9 QUALITY DOESN T COST - IT PAYS! PAGE 9 VERIFICATION OF DATA To ensure quality outcomes of the data entry process, verification of work is required. All data entry must be keyed verbatim as recorded on the questionnaire, and built-in logic checks should be utilized where possible. At Kantar Health, verification of MI data entry quality control meets the following criteria: logic data entry verification is conducted on five percent of entries per project, while simple data entry recorded as exactly entered in the questionnaire is conducted on 10 percent of entries per project. DATA QUALITY VALIDATION Validation records are required and actions must be taken if problems are identified. Typically, one of three methods perform this: 1. Conducting validation independently by two different coders. 2. Applying dependent validation where the validator checks the coding results performed by the original coder. 3. Utilizing self-validation, which is based on experience and competence of the coder. Depending on the type of data collection involved, MI data validation should be undertaken by means of checking the data records produced e.g. questionnaires, data files, respondent re-contact/back-checking and/or monitoring. Checking of data records may include, as appropriate, completeness of the data records, keeping to samples and/or quotas, consistency of responses, and comparison of responses against normal data or between fieldworkers. Respondent re-contact data should include confirmation that the interview or equivalent took place and that instructions were followed, particularly regarding the length of the interview and responses to key questions, including demographics and other qualifying questions related to quotas. Additionally, monitoring can involve listening to interviews at the time they are being carried out, listening to recordings of the interviews, or by accompanying supervisors for faceto-face interviews. Finally, researchers should validate the claimed identity of respondents, where feasible, and researchers should implement procedures to identify and remove fraudulent and inattentive respondents.

10 QUALITY DOESN T COST - IT PAYS! PAGE 10 APPLYING THE RIGHT QUALITY STANDARDS 2018 Kantar Health

11 QUALITY DOESN T COST - IT PAYS! PAGE 11 QUALITY STANDARDS: APPLYING THE RIGHT ONES Assigning quality standards and quality procedures to research projects is done in consideration of the study type and research area, and in accordance with international and local regulations. This is also based on ethical principles and published quality standards, including: Market Research Guidance (MRG), Good Epidemiological Practice (GEP), Good Pharmacoepidemiological Practice (GPP), and Good Clinical Practice (GCP), as defined by the International Conference on Harmonization (ICH). This standard operating procedure applies to all RWR studies. At Kantar Health, when a request for a RWR proposal is received, we apply our RWR assumptions regarding study type, research area and quality standards. Our research team then determines the operational study type based on the scientific and regulatory aspects of the study design and other sources including study protocol/outline. We use the following primary factors to determine operational study types: + + Data Individual subject health data vs. opinion or aggregated data. + + Intervention Interventional vs. observational (non-interventional). + + Outcome Product clinical effectiveness and/or safety vs. no product clinical effectiveness or safety. + + Sites Site-based vs. subject-based data collection approach. We also consider secondary factors, including: + + Sample cohort retrospective vs. prospective vs. cross sectional vs. case control. + + Purpose regulatory (registration/ risk management) vs. access (HTA/ payer) vs. communication vs. marketing. Once the study type has been determined, we decide how the project will be operationally categorized by assigning an operational research area either Market Research (MR), Clinical Research (CR), Health Research (HR), or Pharmacoepidemiology (PE), depending on study type and purpose. In line with project type and research area, we then assign quality standards to the study, most importantly deciding whether study is to be performed under MRG (for operational Market Research studies), as an ICH-GCP compliant study (for clinical trials on medicinal products), or as a study performed per GEP (for health research studies) or GPP (for pharmacoepidemiological studies). This is followed by the assignment of quality procedures to a study. Kantar Health RWR uses standards specific to the four key operational research areas of MR, CR, HR and PE. For example, + + For Pharmacoepidemiology/Risk Management studies in Europe and beyond, the European Network of Centers for Pharmacoepidemiology (ENCePP) guide on methodological standards in Pharmacoepidemiology is important; for studies aiming at the ENCePP seal, following the ENCePP standard is obligatory. + + Good Pharmacovigilance Practice (GVP) may be relevant for interventional and noninterventional studies evaluating product safety/effectiveness, primarily in the research areas Pharmacoepidemiology and Clinical Research. GVP standards will be considered as applicable.

12 QUALITY DOESN T COST - IT PAYS! PAGE Good Outcomes Research Practice standards, such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) GORP, or standards used in Public Health or Health Services Research shall also be considered. + + Data protection standards and promotional standards, as well as other standards relevant for projects sponsored by the pharmaceutical industry shall apply independently. + + If a study involves medical device investigation, the sponsor must confirm its purpose, i.e. MR, HR, PE, CR. For Medical Device/Diagnostic Research (MDDR) studies, the ISO norm is developing to become a consensus standard. For operational MDDR studies, compliance with ISO may thus be assessed by regulators, including the European Notified Bodies, and shall be considered for MDDR projects in addition to the general standards. + + Quality standards for functional project aspects, such as data collection, monitoring, data management, analysis, safety, and writing shall be assessed as appropriate in cooperation with the leads functionally responsible for the relevant areas. PRIMARY VERSUS SECONDARY DATA A NEW SET OF CHALLENGES While there are many standards in place for information collected from subjects directly, including ISO standards that are mainly about primary data verification, the challenges for primary and secondary data quality are very different. That s because with primary data practitioners are challenged by people s memories, inconsistency of mood and change of attitude, while with secondary data, such as databases, data subjects are no longer available for verification. With secondary data, practitioners should be prepared for a new set of challenges. Data quality in an age of privacy concerns usually means that data collected on individual patients is accurate. With the rising use of secondary data that s often fused or integrated, as well as the fact that secondary data is not generated for research purposes, data quality and transparency come into play. Article 7 of the ICC/ESOMAR Code (ESOMAR 2016) states, in part, that: + + Researchers must ensure that findings and any interpretation of them are clearly and adequately supported by data; + + Researchers must on request allow clients to arrange for independent checks on the quality of data collection and data preparation; and + + Researchers must provide clients with sufficient technical information about the research to enable them to assess the validity of the results and any conclusions drawn.

13 QUALITY DOESN T COST - IT PAYS! PAGE 13 WHILE THERE ARE MANY STANDARDS IN PLACE FOR INFORMATION COLLECTED FROM SUBJECTS DIRECTLY, INCLUDING ISO STANDARDS THAT ARE MAINLY ABOUT PRIMARY DATA VERIFICATION, THE CHALLENGES FOR PRIMARY AND SECONDARY DATA QUALITY ARE VERY DIFFERENT. When research is based on secondary data, or a blend of primary and secondary data, practitioners must consider how data integrity and transparency can be ensured. To have confidence in the integrity of this data, a clear view of the quality of the original data sources is required, as the rules under which the data was collected and processed might not meet the requirements to merge with other data. MANAGING THE QUALITY FRAMEWORK At Kantar Health, we have a proven system in place for managing our proprietary Quality Framework. This includes a Global Compliance and Quality Director, who leads Kantar Health s quality program, as well as the designation of local Quality Representatives assigned with a wide range of responsibilities. These include: implementing and monitoring the quality procedures in their unit, conducting internal audits, maintaining local documentation, and managing local vendors. Our active monitoring and management of our Quality Framework, including consultation with Kantar Health s senior management team, ensures that project management processes are always operating effectively. We d be happy to provide further details to you directly. For more information, contact us at info@ kantarhealth.com.

14 QUALITY DOESN T COST - IT PAYS! PAGE 14 QUALITY REALLY DOES PAY In the age of Big Data, data availability is no longer a problem. Instead, practitioners face a new set of challenges ones that include reducing noise and bias, and eliminating false positives. Achieving success in areas such as these will allow for the production of quality data to satisfy a wide spectrum of healthcare stakeholders including patients, caregivers, HCPs, payers and regulators. To maintain a corporate reputation and maximize commercial success, constant attention must be paid to how data is gathered, verified, processed and utilized; and a commitment to quality must be maintained across and throughout an organization s entire value chain. Quality is not a law, but it really does pay off handsomely for organizations that choose to invest in it!

15 QUALITY DOESN T COST - IT PAYS! PAGE 15 ABOUT THE AUTHOR JESSICA SANTOS GLOBAL COMPLIANCE AND QUALITY DIRECTOR Dr. Jessica Santos is the Global Compliance and Quality Director for Kantar Health. Dr. Santos is primarily responsible for providing oversight and support across the 40+ Kantar Health global offices in the area of regulation for interaction with clients, suppliers and others within Kantar Health, Kantar and WPP. Dr. Santos is responsible for maintaining, anticipating and coordinating all activities related to compliance laws/regulations and quality framework on Real World Research and Market Research. Dr. Santos is an experienced statistician, analyst and methodologist. She gained her reputation through her publications and professional committee work in the industry. Dr. Santos is a frequent speaker and contributor in major conferences. She has a PhD in Marketing and MRS fellowship. Dr. Santos is a member of BHBIA Ethics Committee, EphMRA Compliance Network, UK Research Ethics Committee, and reviewer and chair of ISPOR Code of Conduct Committee with patient representatives. FOR MORE INFORMATION WHY KANTAR HEALTH? Please contact info@kantarhealth.com, or visit us at Kantar Health is a leading global healthcare consulting firm and trusted advisor to many of the world s leading pharmaceutical, biotech and medical device and diagnostic companies. It combines evidence-based research capabilities with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and brand and marketing expertise to help clients evaluate opportunities, launch products and maintain brand and market leadership. Our advisory services span three areas critical to bringing new medicines and pharmaceutical products to market commercial development, clinical strategies and marketing effectiveness.