On your radar > Clinical evolution

Email this page News by email Send a press-release

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.

Lilly boosts minority participation in trial with new systematic approach

22-Sep-2011 - US pharmaceutical firm Eli Lilly says taking language, cultural diversity and site location into account helped boost ethnic minority participation in a recently completed trial.

Illingworth Research launches contract medical photography service

21-Sep-2011 - Medical Photography is a potentially valuable yet underused resource in clinical trials according to Illingworth Research, which aims to increase its exposure with a new service.

Russian MoH OKs nearly 600 sites for trials

20-Sep-2011 - The Russian Ministry of Health (MoH) has cleared nearly 600 trial sites for clinical research, easing concerns that the reaccreditation process was taking too long.

Clinpharm Consulting rejigs offering to tackle common PK-PD challenges

15-Sep-2011 - Drug Developers struggle to find PK-PD providers that are fast and efficient says US CRO ClinPharm Consulting, after launching a new suite of services designed to cut risk and maximize return on R&D investment.

Pharma sponsors want better quality CRO performance data, says CRO Analytics

14-Sep-2011 - Pharma industry sponsors want more effective ways of measuring CRO performance according to the team behind a new project aiming to develop a validated set of analysis tools.

Round up of eClinical news

14-Sep-2011 - Outsourcing-Pharma presents a roundup of eClinical news, including developments at BioClinica, OmniComm, ePharmaSolutions and MedNet.

Big CROs losing out as complex trials favour Phase I specialists

12-Sep-2011 - Phase I-focused CROs are winning business from larger rivals as sponsors seek specialists to run more complex studies, market research found.

Social network used to enrol rare disease patients quickly

01-Sep-2011 - Mayo Clinic has recruited patients into a study in one week using a rare disease-specific social networking site.

Risk-based, centralised trial monitoring wanted by FDA

30-Aug-2011 - The FDA is encouraging sponsors to use innovative approaches to lessen reliance on on-site trial monitoring in draft guidance.

Clinigene and Spaulding team up on pharmacology services

23-Aug-2011 - Biocon’s Indian unit Clinigene International has partnered with US counterpart Spaulding Clinical Research LLC to provide clinical pharmacology services.

EMA aims to spark debate on quality in clinical trials

22-Aug-2011 - The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized drugmakers and Big Pharmas alike.

Exclusive interview

Patient recruitment must evolve, says Cutting Edge Information

18-Aug-2011 - Companies looking to outsource patient recruitment need to think outside the box, says Cutting Edge Information’s director of research Eric Bolesh.

MakroCare teams with LSK Global for further Asian expansion

18-Aug-2011 - US-headquartered trial services firm MakroCare has continued its expansion in Asia with a new partnership with South Korea-based CRO LSK Global.

Rapid recruitment in emerging regions can overload sites; FDA

18-Aug-2011 - The US FDA has warned that rapid patient enrolment in emerging markets can overload sites that lack the staff to oversee data as it is generated.

Russia's trial approval rate drops for second consecutive quarter; more resources needed says Synergy

17-Aug-2011 - Russian authorities need to dedicate more resources to reviewing trial applications ahead of new site accreditation rules due to come into effect later this year according to report on the country’s contract research sector.

Exclusive interview

Patient recruitment best outsourced, says market analyst

16-Aug-2011 - Outsourcing should play a vital role in any patient recruitment strategy, says Cutting Edge Information’s director of research Eric Bolesh.

eClinical results round-up

10-Aug-2011 - Outsourcing-Pharma presents a round-up of eClinical quarterly results, including financials from Medidata, Perceptive Informatics, ERT and BioClinica.

Apps turn iPads & iPods into consent & compliance tools

08-Aug-2011 - Systemedicus has developed informed consent and patient compliance apps for iPads and iPods and is looking to license the tools to CROs and sponsors.

Covance establishes more roots in complex contract pharma

04-Aug-2011 - Covance has announced it will collaborate on a genome sequencing project with Broad Institute to create genomic resources for a research model.

ACRO, Quintiles, PRA and Theorem talk strategic partnering at DIA 2011

02-Aug-2011 - The Big Pharma CRO strategic partnering model, its impact on drug development and the contract research sector was a hot topic at DIA 2011.

Realistic, evidence-based patient recruitment goals are key, Shire

01-Aug-2011 - An evidence-based approach to planning during protocol development is key to successful patient recruitment according to Joseph Kim, director of clinical operations at Shire Pharmaceuticals.