Post-Market Evidence for Cancer Medicines in Regulatory and Clinical Decision-Making: A Scoping Review.

Background: Cancer medicines usually have uncertain efficacy and safety profiles when they are first approved by medicines regulators because this evidence usually emerges post-market. Little is known about the extent to which post-market evidence is evaluated and integrated into evidence review processes in regulatory and clinical contexts.

Objectives: The objective of this scoping review is to examine the literature on how post-market evidence on benefits and harms is evaluated and integrated in regulatory decisions and guidance for clinical decision-making.

Does menopause hormone therapy prevent Alzheimer's disease and dementia?

Nerattini M, Jett S, Andy C, Systematic review and meta-analysis of the effects of menopause hormone therapy on risk of Alzheimer's disease and dementia. Front Aging Neurosci. 2023;15:1260427.

Conflicts of interest in submissions and testimonies to an Australian parliamentary inquiry on menopause.

Conflicts of interest (COIs) have the potential to create bias in research, policy and practice. Although disclosure cannot fully protect individuals and public policy from vested interests, it is an important step to support trust in scientific and public discourse, and transparency in decision-making. However, COIs are often unreported, underreported or difficult to identify.

Information on medicines: Does independence from industry influence matter?

No abstract available.

Semaglutide: a new drug for the treatment of obesity.

Semaglutide (▼Ozempic solution for injection, ▼Rybelsus tablets-Novo Nordisk) was initially granted market authorisation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In 2021 and 2022, regulatory agencies in the USA and Europe licensed semaglutide (▼Wegovy solution for injection-Novo Nordisk) for the treatment of individuals who are obese, or overweight and who have at least one weight-related comorbidity. Manufacturer-sponsored randomised controlled trials have shown a loss of almost 12% of body weight over a 68-week period, however, once the medication is stopped people regain most of their pretreatment weight.

Conflict of interest policies at Australian medical schools.

Background: Pharmaceutical industry exposure is widespread during medical training and may affect education and clinical decision-making. Medical faculties' conflict of interest (COI) policies help to limit this exposure and protect students against commercial influence.

Aims: Our aim was to investigate the prevalence, content and strength of COI policies at Australian medical schools and changes since a previous assessment conducted in 2009.

Interactions between Australian cancer physicians and the pharmaceutical industry: a qualitative study.

Objectives: To understand how and why Australian cancer physicians interact with the pharmaceutical industry.

Design: Qualitative study using semistructured interviews, performed by a medical oncologist. Thematic analysis using a combination of deductive and inductive codes.

Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe.

Objective: To evaluate the frequency with which relevant and accurate information about the benefits and related uncertainties of anticancer drugs are communicated to patients and clinicians in regulated information sources in Europe.

Design: Document content analysis.

Setting: European Medicines Agency.

Public reporting of clinical trial findings as an ethical responsibility to participants: a qualitative study.

Objective: To understand how the experiences and views of trial participants, trial investigators and others connected to clinical trial research relate to whether researchers have a duty to participants to publicly report research findings.

Design: Qualitative interview study.

Setting: Semistructured interviews held in person or by telephone between March 2019 and April 2021 with participants in the Canadian provinces of Alberta, British Columbia and Ontario.

(C)onsumer focused (E)ducation on p(A)racetamol (S)ide (E)ffects, i(N)adequate (O)utcomes and (W)eaning (CEASE NOW) for individuals with low back pain: results of a feasibility study.

Objectives: To determine the feasibility of a patient-education booklet to support patients with low back pain (LBP) to reduce paracetamol intake.

Design: Single group, repeated measures feasibility study.

Setting: Community.

Factors relating to nonpublication and publication bias in clinical trials in Canada: A qualitative interview study.

Aims: This study aims to understand factors contributing to nonpublication and publication bias in clinical trials in Canada.

Methods: Qualitative interviews were conducted between March 2019 and April 2021 with 34 participants from the Canadian provinces of Alberta, British Columbia and Ontario, including 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators, 3 research ethics board members and 10 clinical trial participants. We conducted a thematic analysis involving coding of interview transcripts and memo-writing to identify key themes.

How do safety warnings on medicines affect prescribing?

Introduction: Many adverse effects of medicines only become known after approval, prompting regulatory agencies to issue post-market safety advisories to support safer care. Our team evaluated advisories issued by national regulators in Australia, Canada, Denmark, the United Kingdom, and the United States from 2007 to 2016 inclusive, comparing regulators' decisions to warn, effects on prescribing, doctors' awareness and responses to warnings, relevant regulatory policies, and specific case studies.

Areas Covered: Based mainly on our research program and a narrative review, this commentary describes how often regulators issue safety advisories and effects on clinical practice.

Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study.

Purpose: National regulators in Australia and the United Kingdom issued safety advisories on the association between pioglitazone use and bladder cancer in July 2011. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age. This study examined whether these differences in the advisories had different age- and sex-based impacts in each country.

Permissive regulation: A critical review of the regulatory history of buprenorphine formulations in Canada.

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined.