Iddi intensifies global debate on the future of randomized trials in Clinical Research

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International Drug Development Institute (IDDI), a leading therapy-focused Biostatistics and eClinical Services corporation based in Belgium with offices in Boston (MA) and Raleigh (NC) announces that it is hosting a symposium to drive the debate: Are Randomized Clinical Trials Obsolete? Organized with support from the University of Louvain (UCLouvain) and the European Organisation for Research and Treatment of Cancer (EORTC) the symposium will take place at the Auditorium Museum of Fine Arts and Magritte Museum, Brussels, Belgium, on Wednesday, April 22, 2020. Click here to register or email dominique.grisard@iddi.com.

Randomized clinical trials have often been criticized for being conducted in conditions that do not reflect the real world. There is an acute need for more and larger pragmatic trials that reflect clinical practice, but because these trials are conducted with tight budget and limited control, they are often considered as yielding unreliable or even misleading evidence of treatment benefits and harms. In addition, the recent advent of precision medicine has revived controversies about the role of randomization as a core feature in clinical trial design, for testing treatments that clearly have better efficacy than the current standards of care.

Whilst randomization remains a key design feature for confirmatory trials aimed at new drug approval, many innovative non-randomized study designs have been proposed and used in recent years. The IDDI symposium, sponsored by Janssen R&D, Bristol Myers Squibb and Merck Group, will address the sources of bias that continue to threaten sound clinical research now and in the foreseeable future. With the availability of large databases of real-world evidence, the symposium will also question the necessity to carry out expensive and lengthy randomized clinical trials if sophisticated statistical techniques (e.g., based on causal inference) could inform the choice between therapeutic options.

Commenting on the symposium, IDDI’s CCO, Serge Bodart, said: “We are delighted to host a symposium on such an important topic in the field of clinical trials. April 2020 will mark the 40th anniversary of Jay Herson’s paper “Patient Registration in a Cooperative Oncology Group”. That paper, published in the first volume of the journal Controlled Clinical Trials, dealt with sources of bias and randomization practices that existed at the time. Looking back, it is surprising to see how much has changed since 1980.This symposium will serve as a reflection on the current and future trends of clinical trials. ”

The symposium will showcase past achievements, and the current landscape will be described along with realistic proposals to move the field forward. Keynote speakers include Jay Herson, Johns Hopkins U, John Simes, NHMRC Clinical Trials Centre and John O’Donnell, Bristol-Myers Squibb. Other topics to be covered include precision medicine, regulatory affairs and big data. See the full agenda here.

To register for the event please click here to access the registration form and then select the Green Button ‘Tickets’. For more information on IDDI’s Trial Design – Randomization – Data Management and Biostatistics services for Pharmaceutical and Biotech companies, please visit www.IDDI.com.

About IDDI:

International Drug Development Institute (IDDI) is an expert organization in biostatistical and integrated eClinical services that is committed to assisting pharmaceutical, biotech, medical devices, nutrition and Academic Companies in several disease areas, including oncology and ophthalmology. IDDI optimizes the clinical development of drugs, biologics and devices thanks to proven statistical expertise and operational excellence. Founded in 1991, IDDI has offices in Belgium, Boston (MA) and Raleigh (NC).

 

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