News

Enlarge image

PolicyGermanyEU

Papers don’t tell the whole story

09.10.2013 - According to a new study, clinical trial outcomes are more complete in unpublished reports than in publicly available information.

Publicly available sources of information that report findings from clinical trials provide much less information on patient-relevant outcomes than unpublished reports, states a study published by German researchers. The results of the study by Beate Wieseler and colleagues from the Institute for Quality and Efficiency in Health Care (IQWIG) in Cologne found that the publicly available information contained less information about both the benefits and potential harms of an intervention than the unpublished report. Their findings highlight the importance of recent initiatives, such as the AllTrials initiative that aims to make clinical trial outcome data publicly available, in order to provide complete and transparent information to help patients and clinicians reach decisions about clinical care.

In the study, the researchers compared the information available in clinical study reports, which are detailed but usually unpublished accounts of clinical trials, to publicly available sources, including journal publications and registry reports. They found that unpublished reports included complete information for 86% of the patient-relevant outcomes, whereas the combined publicly available sources provided complete information for only 39% of the outcomes. Although the trials included in this study may not be representative of all trials, the findings support a draft policy released in June 2013 by the European Medicines Agency calling for the routine publication of complete clinical trial data.

The authors say: "Our findings show that a substantial amount of information on patient-relevant outcomes required for unbiased trial evaluation is missing from the public record. [Clinical study reports] should be made publicly available as they may substantially influence conclusions concerning the actual position of an individual drug in a therapeutic area."

The study is just another piece in the ongoing debate on transparency of clinical trials set to be implemented in the new EU clinical trials regulation. The pharma industry has stated its will to share clinical data of approved drugs but has also pointed out that it would be essential to exclude any use or misuse of personal data, i.e. when it comes to trials on orphan drugs. In May, the General Court of the European Union ordered the EMA not to provide any raw data on pivotal clinical trials of EU-approved drugs to competitors of originator drugs' developers.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-04/papers-dont-tell-the-whole-story.html

AwardFinlandEU

27.05.2016 The Finnish Technology Academy has awarded US-American innovator Frances Arnold the 2016 Millennium Technology Prize, worth €1m. Arnold is a pioneer in the field of directed evolution.

OncologyUK

26.05.2016 BigDNA relaunches as Iceni Pharmaceuticals with the aim to develop repurposed and reformulated cancer therapies. First order of business: repurpose Merck Serono’s cilengitide as a multiple myeloma treatment.

MicrobiomeFranceDenmarkEU

24.05.2016 One of the pioneering companies developing pharmaceuticals and diagnostics based on the gut microbiome, Enterome Bioscience, has raised €14.5m in a Series C financing round. Among the investors were Seventure and Lundbeckfond as well as Nestlé.

AntibioticsEUUKItaly

20.05.2016 The long awaited global review on antimicrobial resistance by economist Lord Jim O’Neill has been published. It sets out an action plan to defeat superbugs with a huge awareness campaign and rapid diagnostics to be used before antibiotics are prescribed.

LicensingGermanyIrelandSwitzerland

18.05.2016 Bayer is deepening its involvement in CRISPR with a licensing agreement for genome editing patents. Irish partner ERS Genomics holds the rights to the CRISPR/Cas9 tech from Emmanuelle Charpentier, one of the inventors.

M&AGermany

17.05.2016 Newly rebranded Siemens Healthcare has entered the field of molecular testing for cancers with the acquisition of Cologne-based NEO New Oncology.

FinancingUK

11.05.2016 Newly spun out company OxStem has raised £16.9m (€21.5m) to develop regenerative meds for the treatment of age-related disease. It is the largest financing for an Oxford spin-out – or any UK academic spin-out – to date.

FinancingSwitzerland

09.05.2016 Swiss Genentech partner AC Immune has raised CHF42.7m (€38.6m) in order to advance its therapeutic and diagnostic product pipeline in Alzheimer’s disease. The news follows a recently announced R&D collaboration with Biogen.

FinancingSpain

04.05.2016 Barcelona-based epigenetics expert Oryzon Genomics has closed a debt funding round of €10.5m, bringing the total money raised since last year to €27m. The funds will serve to advance the company’s two LSD1 inhibitors in cancer and neurodegeneration.

Open InnovationFrance

03.05.2016 Ipsen is strengthening its ties to long-time development partner Oncodesign, a Dijon-based cancer treatment biotech. The French pharma is handing over the pre-clinical pharmacology for its oncology research programmes to Oncodesign.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Partner-Events

Aachen

Biomedica 2016

Basel (CH)

Chemspec Europe 2016

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • BIOTIE THERAPEUTICS (FI)0.27 EUR92.86%
  • PLETHORA (UK)3.38 GBP12.67%
  • ALMIRALL (E)14.43 EUR7.93%

FLOP

  • 4SC (D)2.59 EUR-20.31%
  • NEUROVIVE PHARMACEUTICAL AB (S)5.25 SEK-4.55%
  • FORMYCON (D)20.15 EUR-4.37%

TOP

  • GALAPAGOS (B)51.86 EUR30.7%
  • NICOX (F)11.00 EUR28.7%
  • GENMAB (DK)1177.00 DKK22.2%

FLOP

  • MOBERG PHARMA (S)38.00 SEK-21.8%
  • 4SC (D)2.59 EUR-21.5%
  • FORMYCON (D)20.15 EUR-18.0%

TOP

  • KARO BIO (S)30.60 SEK1981.6%
  • CHRONTECH PHARMA (S)0.34 SEK1600.0%
  • NICOX (F)11.00 EUR491.4%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)5.25 SEK-89.0%
  • BB BIOTECH (D)44.03 EUR-84.5%
  • BIOTEST (D)17.15 EUR-78.1%

No liability assumed, Date: 29.05.2016