Perils of Peer Review


Dr. Lisa Hutchinson and Prof. John Hickman
Scientific and clinical research that undergoes independent scrutiny by other qualified experts, Peer Review, enhances the integrity, validity, significance and acceptability of the published literature. This process can often be biased, unaccountable, ignorant, and wrong. Lisa and John explore the merits and limitations of peer review, issues that threaten the overall reputation of science (such as misconduct, data fabrication and falsification), and highlight existing efforts to endorse ethical behaviour. They also provide some suggestions to improve the recognition and value that peer review deserves.

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Cancer care in the United States


Mike Kolodziej, MD

Cancer care in the United States: the challenges of access and cost

The US healthcare payment and delivery system is the most complicated in the world, and this is magnified when one considers managing a complex illness like cancer.
This talk reviews how healthcare is paid for and how cancer care is delivered, as well as ongoing efforts to improve quality while controlling cost.

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Reading the literature with a critical eye


Ian Tannock, MD, PhD

In a critical appraisal of trials for cancer Professor Tannock focuses on topics like inappropriate controls, endpoints (surrogates for survival that aren't), under-reporting of toxicity, clinical value as opposed to statistical significance, failure to evaluate quality of life in trials of palliative treatments, and biased reporting.

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Roundtable: Academic publishing


The academic publishing model has been called into question over the past years. Open science movements are growing, the internet is providing new opportunities for access and also breeding excessive volumes of pseudo-scientific content.

Currently, academic publishing is a multi-billion-dollar business, which has drawn understandable criticism. The process of publishing puts tremendous pressure on researchers, charges millions from universities, and increasingly allows the publication of poor-quality content.

Sci-hub launched by Alexandra Elbakyan broke the existing model – is this the first step to reforming access to knowledge? What should the future of scientific publishing look like? How can we enforce quality standards, enable peer review, encourage editorial practices and editorial roles, and how can the remit of research funding be better aligned within publishing?

Join Consilium’s 2nd roundtable to share your opinions and to continue the discussions started at our earlier seminar this year on the Perils of Peer Review.


The challenge of rare diseases


Josie Godfrey

Research into rare diseases has led to more new treatments coming to market. Are the challenges for rare disease drug development and commercialisation really that different to those of more common conditions and do they still need to be accommodated by regulators, HTA bodies and payers? 
This talk considers what is, and is not special about rare diseases and how this may change in an increasingly data driven world. It will consider how collaborative approaches to evidence might help address these challenges. 

Metrics for evaluation of scientific output


Dr. David Colquhoun

The use of metrics to evaluate the quality of individual scientists has corrupted science.  David Colquhoun talks about some examples that show that metrics don't measure what they claim to do.  The movement for "responsible metrics" is well intentioned but doomed to failure. Metrics are produced for commercial profit. If we stop buying them, they'll vanish.

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Master Observational Trials


Dr. Silvia Marsoni

Master Observational Trials: Precision oncology is a heated medical topic arousing contrasting partisanships. Advocates stress the tremendous advantages of tailoring treatments to specific cancer hallmarks. Critics point to its substantial irrelevance in ‘real-world’ patients. Most however would agree that the one‐drug/care‐fits‐all model is in need of an urgent and profound overhaul. I attempt to persuade the audience that the concept of precision oncology is a science-stitched coverlet large enough to cover both research and care. To illustrate and support this concept, I present some of the past and current efforts of my group, mostly in the field of colorectal cancer and specifically honing on the notion that avoiding useless treatments is as ‘precise’ as targeting a rare oncogene.

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EU Horizon Policy: Cancer


Professor Chomienne presents the mission-approach concept to research and innovation and the work of the Horizon Europe Cancer Mission Board to make conquering cancer a mission possible in the near future.

Read the report: Conquering cancer, mission possible | European Commission ( 

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Liquid biopsies for detection of lung cancer


Professor Caroline Dive CBE, PhD

The argument for prioritizing the earlier detection of lung cancer is clear and this is how we step-change patient outcomes. However, challenges of delivering effective screening are substantial and will be discussed.  Professor Dive outlines the approach being taken in Manchester, combining Low Dose CTC scans with blood sample collection within a community at high risk of developing lung cancer.  She presents early data on circulating tumour DNA and circulating tumour cells and an optimistic vision of the future that will require a multi-modal approach for both earlier detection and minimal residual disease monitoring thereafter to enable earlier interventions with high chance of cure.  

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Clinical Trials in Preventive Medicine


Prof Peter Sasieni

Preventive medicine is a proactive approach to minimise ill-health through primary prevention, early detection of disease and treatment of risk factors. Since the recipients of preventive medicine are generally healthy individuals, trials need to be extremely large and often require long follow-up. Additionally, since a relatively small proportion of those recruited will benefit, it is important to ensure that the benefits outweigh any harms of the intervention. In this talk I will consider designs for clinical trials in cancer screening and cancer chemoprevention. I will discuss the ethical and logistic issues raised and illustrate the different designs via major trials in these areas.

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A genealogy of conflict of interest in medicine


Dr. Boris Hauray

Over the last few decades, the category of “conflict of interest” (COI) has gained importance in the medical world, both in the way its organizations operate and in the controversies that have affected it. It has notably become established as the principal lens through which the pharmaceutical industry’s influence on the construction of scientific knowledge, on decisions taken by public authorities, and on prescription practicesis discussed and regulated. Focusing on medicine, this presentation will trace a genealogy of COI: it will examine how, since the 1950s, it has been able to successfully circulate between different social spaces, but also the evolution of the issues that it has mainly served to discuss. Doing so, it will explain the current centrality of COI and reflect on its consequences.

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Complex innovative trial designs


Francois Maignen, PhD

Randomised clinical trials (RCT) remain the reference for the evaluation of the efficacy of new interventions. However, an analysis of the trials registered with the FDA in 2018 showed that many trial designs deviate from this gold standard. New trial designs have recently been implemented to improve the efficiency of RCTs and to accommodate the development of products targeting biomarkers. For these trials, it is important to maintain the operating characteristics of the trial, maintain their integrity and internal validity. Whereas some of these trials have demonstrated their public health value (e.g. platform trials), some of these designs (basket trials) are associated with a very low level of scientific evidence. These new trial designs confirm that regulatory approvals do not always guarantee good clinical evidence. A lot of new trial designs are mostly driven by early regulatory approvals (including expedited or conditional approvals).

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Is EBM being hijacked in oncology?


Dr. Bishal Gyawali

The practice of evidence-based medicine (EBM) has its foundation on evidence generation through research and clinical trials. However, if the evidence generated is unreliable and broken, any practice based on unreliable evidence would adversely affect clinical outcomes. If the evidence can be manipulated, EBM could in fact be a tool that can be misused to push forward treatments that may do more harm than good. Using examples from oncology, in this talk I'll highlight several ways in which EBM can thus be hijacked. Awareness of these issues will help the audience to recognize the flaws in the literature and make an informed decision about the reliability of any generated evidence.

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Сhanging the landscape in rare disease


Emily Crossley

With one groundbreaking international collaboration up and running, Emily Crossley considers the barriers that exist in rare disease research, and the innovative ways in which patient advocacy groups can engage with decisionmakers and industry to change the paradigm.

She will talk about the award-winning Project HERCULES and the DMD Hub – patient-driven research initiatives that are making a tangible difference to the understanding of Duchenne muscular dystrophy (DMD) and accelerating the search for a cure.

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Disclosure of R&D industry payments in Europe


Piotr Ozieranski, PhD

Research on pharmaceutical industry payments to healthcare professionals and organisations has focused primarily on non-research payments, including those made in relation to meals, event sponsorships, and consultancies. However, less attention has been given to payments drug companies make in relation to “research” or “research and development”, including a range of research studies, most notably, clinical trials. This is a key gap in our understanding of relationships between the industry and the healthcare sector, given, for example, the importance of research payments for co-optation of clinical Key Opinion Leaders as well as the evidence of such payments being underreported. Using a stakeholder survey, documentary data as well as the new database this talk will, first, identify and show the distribution of regulatory approaches to disclosure of payments for research and development in European countries. Second, it will compare the two key contrasting regulatory approaches - industry-self regulation as well as government regulation. Third, it will examine the distribution of payments for research and development at the country and company level in European countries with available data. Finally, the talk will suggest short- and long-term solutions to increasing the transparency of drug company payments for research and development.

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Clinical and Economic Data Transparency


Leeza Osipenko, PhD

Shouldn’t clinical data underpinning the product’s characteristics and performance be publicly available for new medicines which received marketing authorisation and are being prescribed to patients? Today, even for products that underwent the health technology assessment process for reimbursement, significant volumes of data remain redacted. Public agencies pride themselves on their transparency initiatives and commitment to patients’ interests. What stands behind these slogans? What data can and cannot be seen? Leeza Osipenko presents results of her research into the transparency practices at NICE over the 20 years and reflects on the positions of the FDA and the EMA.

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Cancer in the Time of COVID and Conflict


Prof Richard Sullivan

Prof. Sullivan will discuss the future of global cancer in the ‘post’ pandemic, increasingly fragile and multi-polar world, end of Western concept of cancer care and the emergence of a new post Westphalian cancer systems order and the paradox and contradictions of modern cancer care driving inevitable global inequalities.

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Promise and Unique Problems of CNS Drug Discovery


Valentin Gribkoff, PhD

While CNS (central nervous system) diseases represent an area of significant medical need, many of these diseases and conditions have defied all attempts at pharmacotherapeutic intervention. In this talk we will discuss some of the reasons for this, and discuss approaches that may prove more fruitful in the future.

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Roundtable:Public voice in healthcare.


In some sectors, such as energy, climate and transport, significant and quite radical changes in policy have been driven by the public, particularly the Green Movement. In healthcare, AIDS activists were able to make a difference but many other aspects of healthcare require urgent attention. Why is public voice in healthcare not gaining sufficient visibility, traction and power?


Access to Multidisciplinary Cancer Treatment


Denis Lacombe, MD

The needs of patients in healthcare systems should define research priorities. Many questions remain unaddressed when new technologies are approved. Optimizing their use in the healthcare systems such as but not limited to combination, sequence, duration, de-escalation, and adjusting study populations-based on clinically validated biomarkers requires, robust datasets addressing medically relevant end-points.

Multidisciplinary pragmatic clinical research addressing such questions, traditionally performed by the non-commercial sector is at the crossroads between treatment development and access. Delivering datasets informative to patients, doctors, HTA bodies and payers should be integral to the process from drug development into healthcare systems addressing the efficacy-effectiveness gap.

Re-engineering the process while integrating new solutions for data access is bound to methodological and economical challenges amongst others. Reforming the process of treatment development in healthcare is long overdue.

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