Italian Medicines Agency Agenzia Italiana del Farmaco

Scientific Seminar on new tools for regulators

Towards new tools for regulators: systematic reviews, patient engagement and health communication – a more consistent continuum? The contribution of Alessandro Liberati and Cochrane Italy to the approval of new medicines and vaccines

Evidence-based medicine (EBM) is widely acknowledged as the most influential revolution occurred in medicine over the past decades, by introducing a novel approach and methodology for the production and analysis of high-quality information to guide decision-making both in the regulatory field and in clinical practice.

On the occasion of the 10th anniversary of the death of Alessandro Liberati – an outstanding advocate of EBM, of the role of independent research and patient involvement – this seminar was an opportunity to discuss the contribution of EBM to the current regulatory framework with particular reference to the management of the COVID-19 pandemic.

Participants: Andrew David Oxman, Research Director of the Centre for Epidemic Interventions Research - Norwegian Institute of Public Health, Holger Schünemann, Director of the Department of Health Research Methods, Evidence and Impact - Cochrane Canada and McMaster Grade Centre, Nicola Magrini, AIFA Director General and Patrizia Popoli, ISS - Chair of AIFA’s CTS.



Pubblicato il: 08 April 2022

Speeches - 27 January 2022

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Evidence-based medicine (EBM) is widely acknowledged as the most influential revolution occurred in medicine over the past decades, by introducing a novel approach and methodology for the production and analysis of high-quality information to guide decision-making both in the regulatory field and in clinical practice.
Alessandro Liberati was an advocate of the EBM movement and one of the founders of the Cochrane Collaboration, and contributed to implement EBM in the drug regulatory process.  Three of his major research areas included the role of systematic reviews, patient involvement and communicating risks and benefits.
Systematic reviews proved especially useful in avoiding publication bias, i.e. selecting possible outcomes of a trial, which may lead to inappropriate conclusions.
As for patient involvement in clinical trials (CTs) and the role of reliable evidence, this has been a longstanding discussion, but previous research has clearly shown that it is possible to conduct scientifically rigorous and ethically sound studies even during an outbreak, or in a conflict zone, also outlining that good research is always beneficial to patients.
A further level of patient involvement consists in informing patients of the risks and benefits of the study, as well as disclosing any conflict of interest of the researcher/doctor who is curing them. This surely represents a step forward for the research community, the Cochrane network and regulatory bodies.

Health communication in and out of public health emergencies:  To inform or to persuade?
During the COVID-19 pandemic we have experienced an infodemic, i.e. overburden of information, which has made it very hard for the public to know what to believe and for health authorities to communicate.
Many different measures have been implemented to control the pandemic, with a trade-off between health impacts and democratic rights. On average, it is noteworthy that democratic governments were slower than autocratic ones to implement (and enforce) restrictive measures.
Communication between the scientific community and policymakers has not always been shared with the public.
As a result, COVID-19-related communications by policymakers, health authorities, researchers, and others can be perceived as untruthful, inconsistent, and opportunistically shared.
On the one hand, more overt communication could potentially make policy changes seem less arbitrary, and could increase support for and willingness to participate in future research.
On the other hand, more candid communication might reduce the perception of effectiveness if people recognize there is more uncertainty, which could also reduce compliance with recommendations and policies.
There is a potential dilemma between enabling people to make informed choices and maximizing compliance with policy decisions aimed at improving health outcomes.
This is not a new phenomenon, being a common issue in the context of health promotion (e.g. campaigns on vaccination, smoking, drug abuse, unsafe sex, obesity, meat consumption and screening). Moreover, sometimes it is also relevant in clinical practice (e.g., in communication targeted at adherence with treatment plans, or for preventive medicine).
Health authorities try (intentionally or unintentionally) to persuade people in different ways: by emphasizing the advantages of the desired option and ignoring or downplaying the disadvantages and uncertainties, by using words and hyperbolic language without presenting numbers, or presenting risk ratios for benefits and absolute effects for harms.
When the evidence of the advantages far outweighs the disadvantages, the difference may be smaller between informing and persuading people; on the contrary, when benefits and harms are closely balanced, it is more likely that information designed to persuade differs substantially from information designed to inform.
It was shown that information may shift to manipulation, whenever it tries to influence by unfairly using spin. Sometimes manipulative information could infringe on people’s autonomy.
Information designed to inform people is clearly based on people’s right to make their own choices, but these choices do not harm other people or create undue collective burden (in this case they restrict autonomy).
Some people argue that autonomy may sometimes be deceptive, i.e. unknowingly shaped by misinformation or affected by cognitive biases. However, this may not justify health authorities or governments to manipulate information or people’s emotions. It is important that those responsible for health communication reflect carefully on avoiding potential unintended effects (nonmaleficence) as well as the intended effects (beneficence).
If persuasive information is well grounded, it may be justifiable to persuade, manipulate, or even coerce people to behave in a desired way (despite some disagreements).
Persuasive messages should always be transparent (despite low certainty evidence), but without resulting in distortion. Any important uncertainty should be acknowledged to avoid reducing trust in health authorities.

COVID19 guidelines for health professionals & the public: plain language versions of the eCOVID Recommendation Map
In his last published editorial on the Lancet, Alessandro Liberati argued that a new governance strategy was needed for clinical research and now it is required for research on public health interventions and policy decisions, also involving the public.
During the pandemic, a useful tool was created by Cochrane Canada in collaboration with the WHO Collaborating Center for Infectious Diseases, McMaster University and many other institutions to gather and analyse guidelines and recommendations for healthcare professionals and the public, called “eCOVID Recommendation Map”.
The purpose of this work was to:

  • Produce and provide decision makers and other stakeholders with a platform that includes all available trustworthy COVID 19 recommendations.
  • Identify COVID-19 recommendations, critically appraise and make them available for contextualization and implementation by decision-makers across the globe as already done for WHO global recommendations on tuberculosis.

The approach is based on evidence mapping and it is also intended to map both the (potential) gaps and abundance in health recommendations. The database is fed through queries on PubMed and screening of grey literature. To date, the database contains over 4,000 recommendations.
Each recommendation is critically assessed and coupled with background information, so that users may understand them. Additional information describes how evidence is used; it is then reported in the “Evidence to Decision” (EtD) framework.  
Information analyzed through the EtDs can be used to adapt recommendations to specific contexts (this was accomplished in South Africa, Brazil and the Czech Republic).
The second phase of this project aims to draft such recommendations in plain language with:

  • easy-to-read summaries
  • balanced statements that include an explanation of the recommendation
  • GIN (Guidelines International Network)-Public Toolkit and the GRADE format of plain language recommendations.

Producing transparent ways of describing a recommendation was already suggested by Alessandro Liberati, which means that his research on the need of transparency in the decision-making process has had a powerful impact on our present activities.

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