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Hot Topics > Clinical evolution

Clinical evolution

Clinical evolution

Randomised clinical trials have been the mainstay of pharmaceutical product development for decades, but will they be designed and carried out the same way in future? With trials tipped to get smaller and patient selection more complex as pharma’s blockbuster model is dismantled, interactive technologies, adaptive designs and new ways to recruit and monitor patients will come to the fore.

update

Trials published by Pfizer didn't match internal docs say researchers calling for CONSORT revision

05-Feb-2013 - Clinical trials made public by Pfizer did not match internal reports or reflect what was done in studies of the seizure drug gabapentin say researchers calling for revision of journal...

JLL bids $123m for Bioclinica and plans imaging bolt-on

31-Jan-2013 - Bioclinica has agreed to a takeover by JLL Partners in a deal that would see the eClinical provider merge with medical imaging firm CoreLab Partners.

FDA Adopts 'Practical' ICH Q&A to Clarify Clinical Study Reports

30-Jan-2013 - The US Food and Drug Administration (FDA) has adopted a practical Q&A  from the International Conference on Harmonisation (ICH) to help sponsors and CROs craft clinical study reports (CSRs), an expert...

Variations in site recruitment performance a risk, says Tufts

16-Jan-2013 - Variation in site recruitment performance is a major risk factor for CROs and their sponsors according to new research.

New Guideline Lays Out Minimum Content of a Clinical Trial Protocol

15-Jan-2013 - Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols.

News in brief

Icon teams with EHR speclalist Cerner

10-Jan-2013 - Icon claims its collaboration with electronic Health record (EHR) specialist Cerner will help drug and device makers streamline data collection.

Parexel buys Liquent for $72m

03-Jan-2013 - Parexel has acquired niche regulatory information management software firm Liquent and raised its guidance for 2013.

Pfizer could re-launch virtual trial programme as soon as 2013

27-Nov-2012 - Pfizer is re-jigging its failed virtual trial model and could re-launch the programme as soon as 2013.

News from CPhI

India will stamp out "fly by night operators" in trial industry, says Gov

27-Nov-2012 - The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.

Risk-based monitoring could simplify trial data QC, according to Annex Clinical

26-Nov-2012 - Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.

News from PCT

CRA turnover in China too high: PCT discussion

21-Nov-2012 - High CRA turnover in China often hinders trials, according to an Oxford University expert.

News in brief

Boehringer set to make E.coli for clinical trials

12-Nov-2012 - Molecular Partners has contracted Boehringer Ingelheim to produce a range of highly potent molecules for its clinical pipeline.

Report from PCT Europe

Is risk-based clinical trial monitoring too flexible for the regulators?

12-Nov-2012 - Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.

DISPATCHES FROM PCT EUROPE

Strategic deals fit with regulators' risk-based site monitoring

08-Nov-2012 - Risk-based site monitoring is easier under strategic partnerships than other relationship models according to Covance.

UPDATE

PCT Europe 2012: Managing risk, emerging markets and industry criticism

08-Nov-2012 - Outsourcing-Pharma.com is in Hamburg,Germany this week to meet the CROs, sponsors and academics gathered at PCT Europe to discuss the future of partnerships in clinical trials.

News from CPhI

Aesica ramps up HPAPI capacity to meet industry demand

07-Nov-2012 - The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.

News in brief

Catalent aims to boost drug delivery through industry-academia partnership

18-Oct-2012 - Catalent has established a new institute in a bid to advance drug delivery by creating links between industry and academia.

Industry too afraid to include children in clinical trials, says expert

10-Oct-2012 - The pharma industry does not include children in clinical research for fear of mentally scarring them, according to ResearchNurses.co.

Icon and South Korean Government team up to drive clinical activity

04-Oct-2012 - Icon has forged an alliance with the South Korean Government in a bid to boost local trial activity.

Quintiles set to boost Scotland's "promising" clinical trials market

02-Oct-2012 - Quintiles has forged a deal with the Scottish Government which it says will boost clinical trial activity in the country.

WorldCare Clinical launches clinical trials review service at request of FDA

02-Oct-2012 - WorldCare Clinical has launched a blinded independent safety and efficacy review service to speed FDA approval of clinical trial data.

EXCLUSIVE STUDY

Open source paradigm could swipe biz from CROs: Beroe

27-Sep-2012 - Open source drug developers could swipe business from CROs in the drug discovery field, according to Beroe.

Clinical trials should involve the elderly more, say experts

19-Sep-2012 - Geriatric patients are left out of trials too often say experts who want researchers to 'open their minds' to the benefits of recruiting the elderly.

Improving Biopharma R&D efficiency a mixed blessing for CROs

06-Sep-2012 - Improving efficiency in biopharma research is a “mixed blessing” for contract research organisations (CROs), according to Wells Fargo.

Online drug accountability systems will replace paper, says Cenduit

04-Sep-2012 - Automated drug accountability systems are becoming “the norm” in clinical trials because they can improve compliance and cut working time drastically, according to Cenduit.