Chronic disease and air pollution: disease trajectory and intervention (ROUTE) study

HEALTH CANADA ADVANCE CONTRACT AWARD NOTICE TITLE: Chronic disease and air pollution: disease trajectory and intervention (ROUTE) study SOLICITATION NUMBER: 1000212402 1. The purpose and explanation of an ACAN An Advance Contract Award Notice (ACAN) allows Health Canada to post a notice for no less than fifteen (15) calendar days, indicating to the supplier community that a goods, services or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the minimum requirements identified in the ACAN, the Contracting Authority may then proceed to award a contract to the pre-identified contractor. 2. Rights of suppliers Suppliers who believe that they are fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities clearly demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If the Bidder can clearly demonstrate they possess the required capabilities, the requirement will be opened to electronic or traditional bidding processes. 3. Proposed Contractor Dr. Jay Kaufman McGill University 1020 Avenue des Pins Ouest Montréal, Québec H3A 1A2 4. Definition of Requirements or Expected Results Started in April 2019, Chronic Disease and Air Pollution: Disease Trajectory and Intervention (ROUTE) Study aims to provide powerful guidance for policy decision and public actions on air pollution in Canada. Among others, a key objective of ROUTE Study is to evaluate the effectiveness of some potential individual- and policy-level interventions in reducing air health effects. Air pollution has major public health and economic consequences, but considerable uncertainty exists concerning which actions can be taken to reduce its effects. Despite mounting interest in understanding the effectiveness of past interventions and whether other possible measures are needed, few epidemiological studies have been conducted to evaluate past air quality regulatory actions. ROUTE Study aims to determine how air pollution burden can be mitigated by intervening at both the individual and the population levels, thus filling important gaps in air health research and policy formation. To achieve the objective described above, ROUTE Study will carry out two sub studies to determine (1) whether long-term reduction in air pollution levels across Canada was related to improvements in public health and (2) whether medication uses moderated air pollution-related morbidity and mortality across the province of Ontario, Canada. Departing from the conventional use of small-size cohorts and standard statistical methodologies (e.g., statistical adjustments) which are subject to many sources of biases, ROUTE Study aims to leverage the advent of Big Data sources and the recent developments in advanced causal inference methodologies in air health research (e.g., g-methods for complex longitudinal data). Specifically, ROUTE Study will use data from two largest existing cohorts in Canada (Canadian Census and Environmental Cohort [CanCHEC] and Ontario Population Health Environmental Cohort [ONPHEC]). CanCHEC comprises Canadians who filled out long-form censuses in 1991 onwards, and were linked to the Canadian Mortality Database to ascertain vital statistics and the T1 personal master file to obtain annual residential postal code since 1991, which was developed by Statistics Canada in collaboration with Health Canada. ONPHEC comprises the entire adult population in Ontario created through data linkage across various provincial administrative databases (including chronic disease databases), health survey data, and environmental exposure data, which was developed at ICES with support from Health Canada. The proposed work to support the two studies described above will consist of the following key tasks: obtaining approvals for accessing CanCHEC and ONPHEC; developing study designs and statistical programming codes using causal inference methodologies; obtaining approval from ROUTE Study scientific team for the proposed study designs, causal inference methodologies, and programming codes (approval process takes one to two months); and completing statistical analysis. Given the importance of ROUTE Study on informing the Government of Canada in developing timely air pollution mitigation strategies, it is critical that the proposed work be completed between November 1, 2019 and February 28, 2020 (contract period). Health Canada also reserves the right to amend the contract to pick up three one-year options that will be built into the contract (May 1, 2020 to February 28, 2023), dependent on funding availability. Failure to meet the imminent timeline for each period and the full contract period will result in losing the funding of ROUTE Study. The proposed work supports ROUTE Study by (breakdown by one contract period and three one-year options):  Contract period (on or around November 1, 2019 to February 28, 2020) • Obtaining approvals for accessing CanCHEC and ONPHEC; • Developing a study design that is suitable for evaluating the causal relationship between long-term reduction in air pollution and incidence of chronic diseases, and obtaining approval from ROUTE Study scientific team for the proposed study design; • Delivering statistical programming codes that implement causal inference methodologies that are suitable for determining the causal relationship between long-term reduction in air pollution and incidence of chronic diseases, and obtaining approval from ROUTE Study scientific team for the proposed causal methodologies and statistical programming codes; • Completing statistical analysis to estimate the causal effect of long-term reduction in air pollution on the incidence of myocardial infarction, and obtaining approval from ROUTE Study scientific team for the study results; and • Submitting a final report summarizing methodologies and study findings that is suitable for peer-reviewed journal submission Option period 1 (May 1, 2020 to February 28, 2021) • Developing a study design that is suitable for determining the causal relationship between long-term reduction in air pollution and mortality, and obtaining approval from ROUTE Study scientific team for the proposed study design; • Delivering statistical programming codes that implement causal inference methodologies that are suitable for estimating the causal relationship between long-term reduction in air pollution and mortality, and obtaining approval from ROUTE Study scientific team for the proposed causal methodologies and statistical programming codes; • Completing statistical analysis to estimate the causal effect of changes in long-term air pollution on cardiovascular mortality, and obtaining approval from ROUTE Study scientific team for the study results; and • Submitting a final report summarizing methodologies and study findings that is suitable for peer-reviewed journal submission Option period 2 (May 1, 2021 to February 28, 2022) • Developing a study design that is suitable for evaluating medications as both an effect modifier and a mediator for the relationship between long-term exposure to air pollution and incidence of chronic disease, and obtaining approval from ROUTE Study scientific team for the proposed study design; • Delivering statistical programming codes that implement causal inference methodologies that are suitable for evaluating medications as both an effect modifier and a mediator for the relationship between long-term exposure to air pollution and incidence of chronic disease, and obtaining approval from ROUTE Study scientific team for the proposed causal methodologies and statistical programming codes; • Completing statistical analysis to evaluate statins as both an effect modifier and a mediator for the relationship between long-term exposure to air pollution and incidence of myocardial infarction, and obtaining approval from ROUTE Study scientific team for the study results; and • Submitting a final report summarizing methodologies and study findings that is suitable for peer-reviewed journal submission Option period 3 (May 1, 2022 to February 28, 2023) • Developing a study design that is suitable for evaluating medications as both an effect modifier and a mediator for the relationship between long-term exposure to air pollution and mortality, and obtaining approval from ROUTE Study scientific team for this study design, and obtaining approval from ROUTE Study scientific team for the proposed study design; • Delivering statistical programming codes that implement causal inference methodologies that are suitable for evaluating medications as both an effect modifier and a mediator for the relationship between long-term exposure to air pollution and mortality, and obtaining approval from ROUTE Study scientific team for the proposed causal methodologies and statistical programming codes; • Completing statistical analysis to evaluate statins as both an effect modifier and a mediator for the relationship between long-term exposure to air pollution and cardiovascular mortality, and obtaining approval from ROUTE Study scientific team for the study results; and • Submitting a final report summarizing methodologies and study findings that is suitable for peer-reviewed journal submission 5. Minimum Essential Requirements Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements: The supplier must be able to establish access to the Ontario Population Health and Environment Cohort (ONPHEC) and the Canadian Census and Environmental Cohort (CanCHEC). Because the contract period ranges from on or about November 1st, 2019 to February 28th, 2020, the supplier must be able to demonstrate their ability to obtain access to both cohorts within the year of 2019, as proven by providing official confirmation letters. The supplier must be able to demonstrate, by providing a link or a PDF document of at least one (1) peer-reviewed scientific paper, past experience in working with ONPHEC or CanCHEC. The necessary high level of knowledge and expertise in causal inference methodologies, as proven by an extensive publication record. Dr. Jay Kaufman of McGill University is one of the most renowned experts in causal inference methodologies in Canada and around the world. He has made significant contributions to advancing the field of causal inference with more than 340 peer-reviewed scientific publications, and 11 books and book chapters. Over the past two decades, he has conducted research to evaluate public programs in the fields of environmental and social epidemiology. His extensive expertise in conducting research in program evaluation and his intimate knowledge with advance causal inference methodologies will enable the ROUTE Study to be completed within the timeframe specified. The supplier must be able to demonstrate their ability to develop and apply a causal inference method that is suitable for determining the causal relationship between long-term reduction in air pollution and health effects in Canada. Regarded as one of the leading causal inference researchers internationally, Dr. Kaufman has been playing a leading role in advancing causal inference methodologies in epidemiology. Dr. Kaufman has developed appropriate causal methods that meet the requirement of this study and thus will allow it to be accomplished within the timeframe specified. The supplier must be able to demonstrate their ability to develop and apply a causal inference method that is suitable for evaluating medications as both an effect modifier and a mediator for the relationship between long-term exposure to air pollution and the risk of chronic disease. A method and related programming code that have already been developed by Dr. Kaufman are directly relevant to this particular study and can be quickly adapted to Health Canada. 6. Reason for non-competitive award Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids. For the proposed procurement, the following exception applies: (d) Only One Person or Firm is capable of performing the contract. Dr. Jay Kaufman of McGill University is currently the only resource that meets all of the minimum requirements. Dr. Kaufman already has consent to access to the Ontario Population Health and Environment Cohort (ONPHEC) and the Canadian Census and Environmental Cohort (CanCHEC). Dr. Kaufman is one of the most renowned experts in causal inference methodologies in Canada. He has developed a series of novel methods and related programming codes that are directly relevant to this project, which will allow it to be completed within the specified timeframe. 7. Applicable trade agreements and justification for limited tendering or the Procurement Strategy for Aboriginal Business Not Applicable 8. Ownership of Intellectual Property Copyright shall vest with the Contractor, although the Contractor shall grant the Crown a license to exercise all Intellectual Property Rights in the Materiel for any public purpose. 9. Period of the proposed contract The contract period shall be from on or around November 1st, 2019 until February 28th, 2020, with the irrevocable option to extend the contract up to three (3) one-year option periods. 10. Estimated value of the proposed contract The estimated value of the proposed contract is $80,000.00, plus applicable taxes. However, this contract will have three (3) option years built into it, dependent upon the availability of funding, worth a combined total of $240,000.00, making the total potential value of this contract over four years $320,000.00, plus applicable taxes. 11. Closing date and time The closing date and time for accepting Statements of Capabilities is November 19, 2019 at 1400hrs EDT 12. Contact Person All inquiries with regard to this Notice must be addressed by e-mail to: Name: Wes Phillips E-Mail: wesley.phillips@canada.ca