Overview:

Expand Clinical Operations and Seize Opportunities in Africa

Despite maintaining regional offices within Africa, many major drug and device manufacturers frequently overlook the continent when sponsoring clinical studies. Cultural barriers, political upheaval and uneven infrastructure are certainly causes for the lack of interest. But Africa offers tremendous expertise and opportunity for drug and device companies looking for cost-effective study sites and appropriate patient populations.

As challenging as Africa may seem, drug companies have made commitments to improve healthcare across the continent, and these companies' clinical development strategies go hand-in-hand with that improvement. In coming years, the drug and device industries will greatly expand their clinical development presence in Africa, mainly in South Africa and a select few North African nations.

Make sure that your clinical strategy team has all the knowledge available about the growth opportunities in these countries. Africa presents a unique profile that interests many multinational life sciences companies. If the following benefits outweigh the challenges for a clinical team — as they often do — trial sponsors will find value in Africa:

Boost Patient Access

Of all emerging regions, Africa has arguably the least access to quality care, ensuring a steady stream of dedicated patients to fill trial enrollments. In addition, the most advanced nations offer highly diverse patient populations that will translate well for submissions in the US and EU.

Leverage Africa's Proximity

Many major European companies are located just across the Mediterranean from North Africa, making travel and communication easier than in Latin America, for example. For American companies, Africa is much closer than Asia.

Benefit from Underutilization

Though trial saturation is not a concern in any emerging markets yet, Africa is the least saturated of all regions. Companies that establish clinical operations bases now will be ahead of the pack when more of the industry turns to Africa.

Africa Emerging Markets Metrics

Executive Summary

    * Average percentage of budget saved by running a site in Africa
    * Average percentage of time saved by running a site in Africa
    * Population comparisons between African nations, the United States and Europe
    * Number of registered studies across profiled African countries
    * Rankings from surveyed companies of benefits and challenges:
          o Patient access
          o Patient retention
          o Regulatory environment
          o Intellectual property laws/practices
          o Cultural concerns
          o Communication and language
          o Clinical trial technology infrastructure
          o Supply chain management
          o Investigators' available knowledge base
          o Data standards
          o Investigator standards
          o Site management standards
          o Anticipated cost

The two chapters in Emerging Markets Clinical Development Series: Africa use primary and secondary information to provide comprehensive overviews of the clinical development environment in Africa's emerging markets:
Section 1: Clinical Development Overview

    * Key demographics (population/ethnic breakdowns, life expectancy statistics)
    * Key economic figures (GDP, labor force, distribution of family income)
    * Disease prevalence
    * Politics
    * Healthcare system
    * Pharmaceutical market (overall picture of market, leading local companies)

Section 2: Clinical Development Environment

    * Percentage of budget saved by running a trial in this location
    * Percentage of time saved by running a trial in this location
    * Assigning clinical development responsibilities

Clinical Trial Environment Scores and Trial Operations Scores:
Environment

    * Available knowledge base
    * Regulatory environment
    * Intellectual property laws and practices
    * Communication/language
    * Culture
    * Anticipated cost

Operations

    * Access to patients
    * Patient retention rates
    * Investigator standards
    * Data standards
    * Site management standards
    * Trial technology infrastructure
    * Supply chain management

Section 3: Individual Company Profiles

This report contains a total of 8 company profiles that contain the following components:
Company Background

    * Company mindset and key clinical feasibility factors
    * Factors that impact clinical environment

Clinical Environment Assessment:

    * Regulatory environment
    * Available knowledge base
    * Intellectual property laws/practice
    * Communication/language
    * Cultural concerns
    * Anticipated cost

Trial Operations Assessment:

    * Access to patients
    * Patient retention rate
    * Investigator standards
    * Site management standards
    * Data standards
    * Trial technology infrastructure
    * Supply chain management

Experience in Region

    * Activity in Region: Maps the geographic scope of the company's clinical operations within the region.
    * Specific to Country: provides information on the company's operations within the country, including year of entry, method of entry and current level of presence within the country.

Clinical Strategy in Country

Responsibility breakdown shows each company's clinical operations assignments among four groups - corporate team outside country, corporate team inside country, multinational CRO, and local CRO/vendor. The data detail 12 clinical responsibilities:

    * Protocol development
    * Site selection
    * Investigator training
    * Patient recruitment
    * Site monitoring
    * Investigator management
    * Data collection
    * Data management
    * Data cleaning/analysis
    * Medical writing
    * Regulatory agency communication
    * Health economics consideration

Clinical Environment and Trial Operations Scores

Shows a company's score for each of the clinical environment and trial operations factors listed above.