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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.

Avoca invites CROs to join Pharma sponsors in Quality management debate

31-Jan-2012 - Sponsors want CROs to join the debate on quality management in clinical research says the Avoca Group, which has invited contractors to sign up to its recently established industry consortium.

Acurian’s opt-in database hits 70m potential subjects

23-Jan-2012 - Acurian says rapid expansion of its opt-in trial subject database is testament to the efficacy of direct-to-patient communication.

Use of subcontractors a strain on GCP compliance, EMA says

19-Jan-2012 - The EMA has warned sponsors must take “great care” when outsourcing to niche subcontractors to avoid violating GCP.

Quintiles invests £3m in biomarker R&D firm; establishes BPO centre in China

18-Jan-2012 - Quintiles has invested £3m ($4.6m) in a new UK-based biomarker R&D company in a continuation of its efforts to build in the field of personalised medicines.

Popsi Cube using iPhones for blood pressure data tracking

16-Jan-2012 - CRO Popsi Cube is using iPhones to track blood pressure data and send questionnaires to patients.

Long-term relationship key to Icon’s Shire deal

10-Jan-2012 - A prior relationship rather than price was the most significant factor in helping Icon win its strategic deal with Shire according to an analyst who says such a trend is good for the sector.

Journals aim at recruitment & data in trial transparency push

04-Jan-2012 - Publication of all clinical data and recruitment targets is needed to boost trial transparency, researchers claim.

Data standards group CDISC gains US charitable status

03-Jan-2012 - The clinical data interchange standards consortium (CDISC) has been designated as a charitable organisation by the US tax authorities, meaning it can now receive tax-deductible contributions from corporate donors.

Clinical outsourcing a threat to biopharm innovation; study

20-Dec-2011 - Outsourcing clinical research may limit innovation and create opportunities for smaller competitors, research found.

Asian CRO group promises faster, better decision making than global CROs

19-Dec-2011 - New Asian CRO Alliance (ACA) can offer faster and better decision making than multinational CROs says Semler Research Centre's clinical development VP.

Specialist ECG firms preferred to big CROs, survey finds

14-Dec-2011 - Biopharm companies prefer outsourcing ECG work to specialist service providers than large CROs, an industry survey found.

Sponsors and CROs differ on perception of service quality, says the Avoca Group

08-Dec-2011 - Sponsor and CRO perceptions of the quality of outsourced service provision differ markedly according to a study by consulting and survey research organisation, the Avoca Group.

Personalised med developers must engage payers earlier; UBC

05-Dec-2011 - UBC & Medco are calling for personalised medicine developers to engage payers in Phase I to ensure necessary data is generated.

AstraZeneca inks multi-year Cognizant biostatistics deal

30-Nov-2011 - AstraZeneca is outsourcing biostatistics and medical reporting work to Cognizant in a multi-year agreement.

Parexel adds imaging tech for early phase CNS research

24-Nov-2011 - Parexel has added functional magnetic resonance imaging technology (fMRI) to its early phase units to advance CNS research.

CROs still seen as good investment says leading banker

22-Nov-2011 - The CRO industry is still considered a good long-term investment and the clinical services segment is set to continue its dominance thanks to sponsor R&D spending, says leading banker.

Medidata plans acquisitions to continue strong profit growth

09-Nov-2011 - Medidata posted double-digit third quarter operating profit growth and is looking for acquisitions to continue the upward trend.

Decline in Russian trial approvals slows in Q3

07-Nov-2011 - New data suggests the Russian MoH is getting faster at reviewing and approving clinical trials.

Innovation needed to kick-start eClinical sector; goBalto

03-Nov-2011 - A “tectonic shift” will kick-start eClinical innovation and move the sector beyond “clunky” systems currently available, the goBalto CEO said.

Patient recruitment hindered by mistrust of clinical trials

18-Oct-2011 - Mistrust of clinical trials and poor patient engagement is limiting recruitment into US studies, an IOM forum heard.

Parexel and NUS team on clinical research training academy

11-Oct-2011 - US CRO Parexel has set out to foster clinical research talent in Singapore through a new training academy

Investment prompts trial tech expansion at Exco InTouch

03-Oct-2011 - Exco InTouch is to accelerate expansion in clinical technology after a venture capital group invested in the company.

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.