state of global clinical research trials

© 2011 Wipro Ltd - Confidential

The State of Global Clinical

Research Trials

© 2010 Wipro Ltd - Confidential 2

© 2009 Wipro Ltd - Confidential 2 © 2011 Wipro Ltd - Confidential 2

3

1 Overview

Survey Findings

2 A Wipro and UBM TechWeb Research Survey

Agenda

4 Key Takeaway


Overview


An Overview

The pharmaceuticals, life sciences, and biotech sector

• Intense competition and growing opportunities in the pharmaceuticals, life sciences, and biotech sector

• Emerging markets are being seen as potential research and development sites as much as potential sales targets

• Rising incomes in emerging economies increasing demand from reputed multinationals and manufacturers

• Drug market in China, Valued at USD 33 billion in 2007 is expected to be valued at USD 126 billion by 2015

• Global sales of life sciences products outside of the U.S. expected to increase steadily in next few years, biologics drugs sales are booming

Clinical Trials

• Drug companies wishing to enter biologics market likely to face conducting clinical trials to gain regulatory approval

• Clinical trials are a significant component of cost of developing new medicines and drugs. Thus the sector needs to tap ways to lower R&D costs and to reach new markets for patient trial supply and as a market

• Clinical trials in emerging markets offers a potential solution for these objectives yet there are significant challenges –

• Forging partnerships, supply chain support for the partnership, data gathering and analysis requirements for compliance with regulatory mandates of mature markets.


Survey


A Wipro and UBM TechWeb Research Survey

In May and June 2011, UBM TechWeb conducted a study on the state of

clinical trials, on behalf of Wipro. The survey included 116

biopharmaceuticals professionals who have begun or plan to begin

conducting clinical trials in emerging markets.

Methodology

38

22 19

16

5

Life Science Pharmaceuticals Biotech Biopharmaceuticals Biologics

Percent distribution respondents by sector


Survey Findings


Emerging regions involved in trials

46

37 36

34

11

Emerging Regions that will be involved

in the trial (% of respondents)

Asia

Eastern

EuropeSouth

AmericaSoutheast

AsiaOther

• 46% respondents target Asian market for

clinical trials

• 59% respondents already conducting clinical

trials in emerging markets

•More than 50% respondents say they are

Somewhat-Heavily influenced by subject

availability in nascent markets

•55% respondents say 60% trials still

conducted mature markets

Route to enable global clinical trial infrastructure

• 15% relying on a functional service provider hub-and-

spoke model, where CROs on-site are managed by hub

teams from major city sites.

• 26% respondents say they are either acquiring local

infrastructure, building it up using their own resources,

or using a third-party contract research organization

(CRO) to deliver services for site monitoring, data

management and other clinical activities.

• 41% are harnessing CROs as service providers in one

capacity or another

• 7% are opting for systems integrators’ cloud-based

services

•These respondents also feel that outsourcing is an

increasingly attractive option


Challenges of Outsourcing Trials

Supply

• Supplies for trials need to be maintained by first-patient-in date, failure can cause delays or disqualification of result

Logistics

• Customs clearance to deliver materials, assuring appropriate packaging and labeling for outgoing specimens, securing depot facilities in-country for just-in-time delivery. 57% respondents say these challenges are significant.

Others

• Social or economic challenges, difficult-to-negotiate bureaucratic infrastructures that increase security or other handling demands.


Acceptance of data from emerging markets

57 29

14 Somewhat

Concerned

Very

Concerned

Not At All

Concerned

• 86 % respondents say that they are somewhat or very

concerned about how regulatory agencies in the U.S.

and Western Europe react to data from emerging

market trials

• Questions over reliability and whether results could

be extrapolated to North American audiences with

different genetic backgrounds and lifestyles are being

asked about clinical trials conducted outside the

U.S.A

• 55% respondents feel timing of data availability was as

good in emerging markets as in mature markets, 13%

said it was better

• Almost 50% respondents are satisfied with capabilities

of emerging markets for trials, more that 30% even

think that capabilities are highly advanced.

NEGATIVES

POSITIVES

Concern regarding acceptance of data from

clinical trials conducted in emerging markets by

U.S. /EU regulatory agencies


Cloud and Social Media

Issues Faced in both emerging and mature markets can be addressed with an integrated suite

of applications for clinical development

Accessing clinical operations support and consulting services from third parties can be

beneficial

Cloud can facilitate business process integration, standardized electronic data management

and data capture processes spanning multiple geographies

29

29

20

12

10

Future Plans

Embraced private cloud in own datacenters

Embraced both private and public cloud

Embraced public cloud from third-party provider

No plans

% of respondents embracing cloud for hosting clinical trial data


Cloud and Social Media

38

33

29 Yes

Maybe

No

• Respondents feel need to drive better understanding of data accumulated during testing phases for both home

conducted as well as trials in emerging markets.

• Social Media is playing a big role in gathering analytics to improve clinical trial processes. Organizations also using

social media as a means to recruit patients for trials.

Challenges

• 67% of respondents who use/plan to use SM say that

establishing an analytics approach and data capture

methodology presents a challenge.

• 64% say they are concerned with how to integrate

self-reported or observational data with controlled

trial data.

• 40 % expect that accounting for missing data (such as

when a patient drops out of a social-media enhanced

virtual trial) could be an issue.

Respondents (%) using/planning to use SM/online

communities for real-time information or

monitoring drug effectiveness


Takeaways


Key Takeaways

Pharma, life sciences, and biotech companies need to….

Take a proactive approach to navigate the changing nature of drug

discovery on all its levels

Reconstruct supply management to reduce weaknesses in

database design and close gaps around clinical trial data integration

Become more agile in analyzing data returns, to avoid safety

concerns,

Explore how new technologies, such as the cloud, may help them

solve not just application issues across the globe but specifically

speed implementations in remote regions


To read the complete report please visit the link below

http://www.wipro.com/landing-pages/Pages/pharma-research.aspx








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