13 January 2017

Senior researcher Wietske Kievit (department for Health Evidence) and PhD candidate Floor Berden (Gastroenterology and Hepatology) have illustrated this paradox in recent papers published in PlosOne and NTvG.

Paradox
Pharmaceutical companies are under increasing scrutiny because of their strategy for gaining market access and reimbursement authorisation for novel drugs. The tool most often used is that of a randomised controlled trial (RCT) in a highly selected population that has a high chance of responding on the treatment but a low chance of developing side effects. This population differs to a large extent from real-life patients, who have diverging characteristics that can influence effectiveness and safety; these include co-morbidity, age and disease severity. This leads to the paradox that medicines are being used in daily practice for situations and patients which are not investigated in the original trials.

Senior research Wietske Kievit (department for Health Evidence) and PhD candidate Floor Berden (Gastroenterology and Hepatology) have illustrated this paradox in a recent paper published in PlosOne. They researched the situation with protease inhibitors telaprevir and boceprevir for hepatitis C patients. Nearly half of real world hepatitis C patients would have been excluded from registration trials, and these patients developed more serious adverse events than eligible patients .

Better research
In a publication in the journal ‘Nederlands Tijdschrift voor Geneeskunde (NTvG)’Kievit and Berden discuss research designs that can complement findings from RCTs, such as pragmatic trials, enriched trials, adaptive pathways, early access programs and patient registries. The aim is to stimulate debate among different stakeholders so that they answer the right question at the right time using a suitable research methodology.

PlosOne: Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study
NTvG: Nieuwe geneesmiddelen sneller beschikbaar voor juiste patiƫnt

Te streng deurbeleid registratiestudies

Related news items


Miniaturized microfluidic platform for automated epigenetic profiling

6 May 2021

Together with Fluidigm, a US-based company focusing on microfluidics, the team of Hendrik Marks publishes in Genome Research the development of a powerful plug and play ChIP-seq platform for minute amount of cells, such as embryonic specimens or small biopsies.

read more

Broken teeth coronastress poses a danger to our teeth

6 May 2021

Teeth grinding and molars on top of each other: stress from corona causes an increase in dental damage. That's what they noticed at the department of dentistry at Radboudumc.

read more

Annual Paper Awards of Research Theme Tumors of the Digestive Tract

4 May 2021

The annual Paper Awards session of the Research Theme Tumors of the Digestive Tract took place at the 22nd of April. The selected candidates prepared wonderful informative movies, that were judged by the public of the RRR and by our patient representatives.

read more

Dutch Children's Formulary now also in use abroad Drug database for pediatric dosing available online for German, Austrian and Norwegian physicians

30 April 2021

The Kinderformularium, developed in the Netherlands, now also provides pediatricians and pharmacists abroad with a database of drug dosage recommendations specifically aimed at treating children.

read more

Foundation Fighting Blindness Awards 1.4 million dollars for Rob Collin and Carel Hoyng

29 April 2021

Two researchers from the Radboudumc have received a prestigious award from the Translational Research Acceleration Program of the Foundation Fighting Blindness USA.

read more

Radboud university medical center appoints thirteen female professors

29 April 2021

Their fields of expertise cover the entire (bio-)medical field, ranging from fundamental and translational to clinical research, education and patient care.

read more