Michael Burgess

Introduction: Over the years, there have been significant advances in oncology. However, the rate that therapeutics come to market have increased while the strength of evidence has decreased - leaving decision makers with more uncertainty than ever before. Currently, there is limited understanding about how this uncertainty is understood and managed in provincial funding decisions for cancer therapeutics. Methods: A qualitative, two-phase study approach was employed. Phase I comprised of semi-structured key-informant interviews (n=6) with senior officials from four Canadian provinces (BC, AB, QC and ON). In part II, a document review of the uncertainties found in clinical evidence in the pan-Canadian Oncology Drug Review (pCODR) assessments was conducted. Interviews in part I were audio-recorded and transcribed verbatim. Results: Participants included stakeholders from British Columbia (BC) (n=1), Alberta (AB) (n=1), Quebec (QC) (n=3) and Ontario (ON) (n=1) whom held a variety of roles in ministries of health, cancer agencies and national health technology assessment (HTA) organizations that evaluate evidence and make funding recommendations. Participants reported considerable uncertainty related to a lack of solid clinical evidence (early-phase clinical trials: generalizability, immature data and the use of unvalidated surrogate outcomes). Clinical uncertainty was exacerbated with high costs and accelerated approvals. Other sources of uncertainty were related to external influences. Proposed strategies to deal with the uncertainty included risk-sharing agreements, collection of real-world evidence (RWE) and ongoing collaboration between federal groups and provinces. The document review added to the reported uncertainties by classifying them into five main categories: trial validity, population, comparators, outcomes and intervention. Conclusion: This study highlights that decision makers have to deal with more uncertainty in funding decisions for cancer drugs than ever before and that this uncertainty generally stems from clinical trials. Since only one decision maker could identify a deliberative priority setting process and cancer drugs are rarely reassessed, this situation might leave ineffective drugs in the health system. These drugs can incur opportunity costs. There is a critical need for transparent priority setting processes and mechanisms to reevaluate drugs to ensure benefit given the high level of uncertainty of novel therapeutics.

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Science is increasingly affecting populations across the globe, and individuals and communities are growing more and more aware of the possible benefits and harms created by new technologies and changes in related policies. Prompted by inadequacies in representation, legitimacy, and trust, there is a need to increase public involvement in decisions regarding the development and implementation of science and technology. Due to claims that the public lacks the necessary knowledge to participate in these democratic processes, this thesis explores whether or not the presence of misinformation during deliberation undermines the usefulness of engaging publics for policy advice. The BC Biobank Deliberation brought together twenty-one individuals from across the province to explore the values and interests that ought to guide the governance of biobanks (repositories of annotated human biological materials often used as resources for research), and to test and evaluate a model for involving diverse publics in policy-making. As information related to biobanks is challenging to capture and disseminate, technical inaccuracies – those resulting from factual scientific or social information related to biobanking – and conceptual inaccuracies – those resulting from information considered to be outside the scope of biobanking, such as linking activities which are not facilitated by the existence of biobanks, to biobanks (e.g. cloning) – arose during deliberations. The analysis of this misinformation in the BC Biobank Deliberation seems to indicate that technical and conceptual inaccuracies play four main roles in deliberation: 1) no effect; 2) stall; 3) distraction; and 4) development. In general, when an overview of the scientific and social information related to the topic is provided during an engagement activity, participants who had little or no knowledge of the subject prior to being informed were able to deliberate on a variety of issues related to biobank governance. Findings indicate that in certain instances misinformation may help to develop deliberation, moving participants towards decision points related to biobank governance. This helps to show that scientific knowledge is not necessarily a prerequisite to participating in decision-making processes.

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