Important information about the benefits as well as the clinical uncertainties of cancer drugs are often omitted from information intended for healthcare professionals and patients, an investigation found .
Including more relevant information about such drugs could help patients and their doctors make more informed treatment choices, according to the study led by King's College London and the London School of Economics and Political Science.
Previous studies have looked at how information on drug risks and adverse effects was communicated to patients, but the researchers sought to widen this to include how the benefits and potential harms of drugs are communicated.
To do so, they analysed the content of summaries of product characteristics written for clinicians, patient information leaflets, and public summaries for 29 anti-cancer drugs that received a first marketing authorisation from the European Medicines Agency (EMA) during 2017 to 2019. The drugs they examined covered 32 separate cancer indications. The information on the drugs' benefits were compared with the information available in regulatory assessment documents compiled during their marketing authorisation process.
Information Frequently Lacked Relevance to Patients
The analysis, published in The BMJ, found that both patient and public-facing information sources often lacked relevance. For instance, nearly all the summaries of product characteristics communicated full information to clinicians about the number and design of the main studies, details of any control arm used, study sample size, and primary measures of drug benefit. However, none of the patient information leaflets provided information about the drug benefits that patients might expect based on study findings, and nor did any give details about how the drugs were trialled. Instead, potentially less relevant information for patients, such as how a drug works in the body, was consistently included.
Scientific concerns about the reliability of evidence on drug benefits, which were raised by EMA regulatory assessors for almost all drugs in the study sample, were rarely communicated to clinicians, patients, or the public, according to the researchers, who also said they found instances where details about a study were inconsistent with those in European public assessment reports.
Important gaps and uncertainties in the evidence base, such as whether a drug extended survival or improved quality of life, were also rarely reported, they said. Dr Courtney Davis, reader in global health and social medicine at KCL, who led the investigation, said: "Patients with advanced cancer often need to weigh a small, or even uncertain, increase in survival against serious treatment toxicity that can negatively affect their quality of life. They need accurate information about the benefits they can expect, and any uncertainties or evidence gaps around those benefits, so they can make informed decisions that are in line with their preferences and needs."
The investigators acknowledged some limitations in their study, such as including only new cancer drugs. Also, they could not say whether the shortcomings in public-facing information applied to drugs for other conditions. Nevertheless, they concluded that "important shortcomings" in information on cancer drugs for patients could mean that "clinical decisions may not align with their preferences and needs".
Regulatory Agencies 'Should Pay Closer Attention'
Writing in a linked editorial, Timothy Feeney, a research editor at The BMJ, and colleagues, said that the takeaway message was that "information about drugs is rarely communicated well – and particularly not communicated well to patients". However, it remained "unclear whether this gap is interfering with shared decision making". They suggested that whilst information on drugs was out in the public arena in static form, "they will likely benefit in the future from being digitalised and embedded in electronic medical records and clinical workflows".
The editorial authors concluded that "regulatory agencies should pay closer attention to important gaps in information for patients, and further research should aim to determine more precisely where these gaps occur and to work with patients to fill them".
The study was partly funded by Health Action International and the EU Commission’s Consumers, Health, Agriculture, and Food Executive Agency. The study authors declared no conflicts of interests. For the editorial, Timothy Feeney declared unrelated consulting work for Takeda, Pfizer, Acadia, and iHeed.
