Current Topics in Global Clinical

Research

1

Current Topics in Global

Clinical Research

SoCRA RTP 02 March 2015

Mary K.D. D’Rozario

MSCR, MBA, CCRP, RAC, CCRA

mary.drozario@crplink.com

@marydrozario

marydrozario

marykddrozario

Ukraine InformationProvided By

v. 2, 03 March 2015

Goals of this Presentation

Look at specific current topics around the world to

increase awareness of the wide variety of topics

which can impact the pace and direction of clinical

research.

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Speaker has no economic or other conflicting relationships with any of the products or companies cited.

Past Events That Impacted the Speaker

• 9/11 - 2001

• SARS - 2003

• Import/export changes in Russia – year ???

• Hurricane Katrina - 2005

• Southern California “Great Blackout” - 2011

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Dengue & Chikungunya Fever in the Caribbean

Old Diseases Make a Global Move

+ Climate Change

• Dengue Fever 400 million infections a year, 4.7% of people in endemic

areas / year 4 different viruses 2003 Caribbean nations formed regional coalition to control

virus

• Chikungunya Fever Average 200,000 infections a year over last 10 years First seen in the Caribbean in December 2013 After outbreak in St. Martin, tourism searches dropped 75%* 37 Americas region deaths in 2014 (per WHO)

• Both Carried by mosquitoes that exist in the United States. Have been locally transmitted in the United States.

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*Robles S. (8 Feb 2014). Virus advances through east carribean. The New York Times. Citing Kyak searches.

Current Vaccine Studies, Vaccine Market

• Dengue

First Phase III study of tetravalent vaccine completed 2014 - Infection rate reduced 56%

• Chikunguya

As of last year only one clinical study for Chikunguyavaccine, 25 patients

Estimated vaccination market for Caribbean tourism alone up to $1.5 billion

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Sanofi Pasteur. (28 Apr 2014). The world’s first, large-scale dengue vaccine efficacy study successfully achieved its primary clinical endpoint.Alsumidaie M. (19 Nov 2014). Crippling caribbean virus: Opportunity for clinical research. Applied Clinical Trials

European Medicines Agency

Government Administration Drama

• Executive Director

Selection in 2011 didn’t follow administrative procedures, one potential candidate not interviewed

Executive Director removed from job in November 2014, Deputy Executive Director in charge of agency

Issue remains open

• One of the items on the table:

EU clinical study information database and confidential commercial information

• Legal challenges go back to at least 2011

• Sued by AbbieVie to protect information, settlement protected some information

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UKRAINE OVERVIEW

• Largest country in Eastern Europe

• Located in the World Health Organization

European region

• Capital – Kiev (about 4 million)

• 27 regions

• Population (2014) – 45,426, 200 (7th

largest in Europe) (http://www.ukrstat.gov.ua)

• 2200 hospitals, 10800 out-patient clinics,

48 Scientific-research institutions

http://www.ukrstat.gov.ua/

http://www.moz.gov.ua/)

SPRI SlideUsed with Permission

Ukraine-Russia Conflict

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406 CT sites59 CT sites

According to State Expert Center-Ukraine clinical trials are currently run at 406 sites, 59 sites are located in a conflictzone (Donetsk, Lugansk regions). Total of over 1,476 experienced centers in Ukraine SPRI Slide

Used with Permission

Ukraine – Other news

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SPRI SlideUsed with Permission

In terms of Association agreement with the European Union implementation in Ukraine, the following steps are planned for 2015-2017 by the new government:

• LATE BREAKER 18 Feb 2015

Ukrainian legislation regarding application procedure for Clinical trials.

The Order mainly effects the procedure of initial and Amendment submissions and as was discussed with MOH previously the new format of approval will allow customs to implement at 7% VAT instead of 20% rate for comparator drugs imported.

• Deregulation of pharmaceutical market

Reduction of the quantity of licenses and approvals by elimination of licenses and approvals for some types of activities;

Acknowledgement of drug registrations, licensed in the EU, USA, Canada, Australia, Japan.

• Transformation and modernization of the hospital network and 3-level system building (local hospitals regional hospitals, national reference centers)

• Law adoption on Insurance Medicine

Ukraine – Major Sponsors of Clinical Trials

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SPRI SlideUsed with Permission

89

76

66

6161

48

37

3424

24 23GlaxoSmithKline

Pfizer

Boehringer Ingelheim

Sanofi Aventis

Astrazeneca

Janssen

Hoffman-La Roche

Bayer

Teva

Takeda

Astellas

According to cc.gov 266 sponsor companies conducted/are conducting clinical trials in Ukraine as of 1 Feb 2015

Ukraine – Quantity of Approved Clinical Trials

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SPRI SlideUsed with Permission

0

50

100

150

200

250

300

2008 2009 2010 2011 2012 2013 1st half of2014

227

184

220

250265

233

155

177

142

177

201213

177

108

5042 43 49 52 56

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Total

International MCT

Domestic CT

The total quantity of clinical trials in 1st half of 2014 has increased by 37% compared to the same period of 2013

Ebola in West Africa

Worldwide News Lede

• Ebola studies came too late, couldn’t enroll

Challenges:

• Standard of care and clinical outcomes vary widely by site

• Global standard of care variance creates additional ethical issues

• Access to laboratory testing limited

• Clinical Care for Other Diseases

Effects on public health infrastructure

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Slide used at presentation incorrectly stated “East” Africa.

India Regulations

• Times of India Headlines in 2014:

370 Die in Clinical Trials in 2 Years, Kin of only 21 Get Compensation

Row Over Clinical Trial as 254 Indian Women Die

• Regulatory Changes:

Investigators can only work on 3 clinical trials at a time

Placebo controls must meet Declaration of Helsinki current version requirements

Death and injury compensation

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China

Economic Growth

• Hospitals growing at more than 13% / year

• Healthcare spending increasing 20% / year

• Partnerships with other countries to keep up with education for employees

• By 2020, 25% of the world’s elderly will live in China

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