Emerging Markets Clinical Trials: Africa (PH147)

&nsbp;

CLICK TO DOWNLOAD
Published 2010
117 Pages
300+ Metrics
70+ Charts and Diagrams

Overview Metrics Excerpts

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 drug market 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 market 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 in these Emerging Locations
Of all emerging locations or 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.
Back to Top
Back to Top
Emerging Locations Clinical Trials 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:
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 these emerging locations
- 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.
Back to Top
Emerging Locations Clinical Trials Report Sample
The following is a short excerpt describing South Africa's healthcare system. The full report explores this topic in depth, as well as other aspects of South Africa's clinical trial environment, including demographics, economics, and politics.
Healthcare in South Africa
The South African healthcare system consists of a large public sector that services about 80% of the population and a rapidly growing private sector that offers the remaining approximately 20% of people significantly better quality of care.
The standard of care in South Africa is the best on the continent, especially in private hospitals and clinics and especially in the urban and coastal areas. Professional medical education is considered excellent, and many doctors cross-train in Europe or the US. Most health professionals work in the private sector and in urban areas. For example, 40% of all South African pharmacists work in Gauteng province in the private sector. Guateng is home to Johannesburg and Pretoria, two of the nation's largest cities. Some 80% of doctors work in the private sector. The consequence of such concentration of health professionals within the private sector is understaffing in rural, publicly funded hospitals and clinics.
South Africa spends almost $25 billion annually on healthcare, which amounts to about $500 of healthcare spending per capita, $88 of which is out-of-pocket spending. The country's healthcare spending as a percentage of GDP is approximately 8.5%, a figure well ahead of most African nations and even slightly higher than some developed nations, including the UK and Japan. (Tables and charts appear in the accompanying summary).
South African governmental spending accounts for 42% of total healthcare spending while servicing 80% of the population. Private spending represents almost half of all spending, while out-of-pocket expenditure is 10% of the total.
Gap in Healthcare Quality Mirrors Economic Divide
Despite misperceptions to the contrary, the quality of private healthcare in South Africa is excellent and comparable to that found in developed nations. Private, urban hospitals are technologically modern and staffed with qualified healthcare professionals. However, the same cannot be said for public facilities, particularly in rural areas. This gap between the private and public standards of care is exacerbated by high poverty, unemployment and generally underdeveloped infrastructures in the rural parts of South Africa. This disparity does not affect clinical trial development significantly since the vast majority of trials take place in urban, modernized hospitals and clinical facilities.

The following excerpts, also focused on South Africa, are taken from section 2, "Clinical Development Strategy." This portion examines site selection, patient access and retention and working with Contract Research Organizations.
Special Reconnaissance Required for Site Selection in the Public Healthcare Sector
The only caveat to this observation is that the vast majority of trials are conducted in facilities within the private sector, where hospitals and clinics are often world-class. For trials that take place in the public sector, though, sponsors and CROs can expect a significant drop in the quality of the clinical environment across all the factors measured in this report.
A director of a large CRO interviewed for this report said companies planning to carry out trials in the public sector can certainly do so but that reconnaissance is necessary.
"When you get to the public sector hospitals, you need to check the infrastructure in that, Do they have sufficient storage space? Do they have sufficient filing cabinets? Do they have access to, if it's required, a centrifuge? In the lab cabinets in the ward, can they spin down the blood if they need to?'" the interviewee said. "This sort of purely, day-to-day operational things - you would make sure the site is adequately equipped."
Clinical Trials in Africa: Access to Patients and Patient Retention
As in all emerging markets, there is keen interest in the patient population. South Africa offers a patient pool with unusual biological, ethnic and genetic diversity. There are dozens of ethnic subdivisions within the black population, and there are sufficient numbers of other racial groups to make the procurement of a mixed population relatively easy for clinical trials in Africa.
Additionally, the population carries a disease burden that includes communicable or developing-nation diseases and conditions such as TB, malaria, trauma and post-traumatic stress disorder, as well as diseases associated more closely with developed nations; a growing segment of the population is facing diabetes, cardiovascular disease, oncological disease and stroke.
Back to Top