Monthly Archives: August 2014

Advantages and Challenges of Conducting Clinical Research in South Africa

Get To Know The South African Healthcare System

The South African healthcare system consists of public healthcare, which is financed and managed by the South African government, and private healthcare, which is primarily funded by health insurance and private direct fee for service payments. Private healthcare consumes more than 50% of total healthcare spending in South Africa, but only services about 20% of the population able to afford health insurance or direct funding of their healthcare needs.

South Africa Flag RoundThe Attraction of South Africa as Clinical Research Destination

South Africa is classified internationally as a developing country and is often viewed by the less-informed as a poorly developed African country. This is far from the truth.  South Africa has a long history of conducting clinical research; this translates to interest of the medical profession in furthering their knowledge and remaining at the cutting edge of medical development. This is a good indication of the pool of experienced clinical research staff available for research, which is growing and developing as the research environment changes over the years. Clinical research experience is of paramount importance in the South African research environment: it is a regulatory requirement that investigators may only participate as principal investigator after having participated in at least two different clinical trials as a sub-investigator.

A Sophisticated Infrastructure and Clinical Trial Support System

South Africa has a sophisticated infrastructure and clinical trial support system available. Laboratory support to process and analyze blood and tissue samples is readily available in all the large metropolitan cities in South Africa. Most, if not all, of the major laboratories have a clinical trial division that specifically caters for the clinical trial environment, and usually have some partnership/working relationship with the large multinational analytical laboratories. All FREEPIK Medical Imagesthe clinical laboratories are audited and accredited by SANAS. These facilities meet all of the international standard requirements.

Product Depots with Strict Control Mechanisms in Place

As South Africa is located quite a distance from the major manufacturing facilities in the USA, Europe and Asia, investigational product depots are often used to import and distribute clinical trial products to site. These facilities adhere to all international packaging and manufacturing (GMP) and clinical trial requirements (GCP). As they generally receive, store, and distribute clinical trial investigational product for a number of different studies and companies, they have very strict control mechanisms in place to ensure confidentiality and safety of clinical trial product. They are able to manage all types of investigational product at all temperature ranges.

Interested in more in-depth information on this topic? Download our complete article from the May 2014 Journal for Clinical Studies:

CTA Button So Africa

 

 

 

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The New Treatment Paradigm in Cancer Research

Dr J S Macdonald MDDr. John S. Macdonald
Senior Consultant for The Oncology Consortia of CRITERIUM, INC.

In the past, typical anti-cancer systemic therapies that worked, albeit poorly, did so by killing cancer cells only slightly better than they killed normal cells. There were relatively few of these drugs and they were given to patients with all kinds of cancers. This toxic therapy could be depended upon to make patients sick all the time while rarely making cancers significantly improveTo effectively develop these new treatments, clinical investigators must not only be excellent physicians but also be first rate molecular and cellular biologists.

CHEMOTHERAPEUTIC AGENTS KILL MORE CELLS THAN THEY SHOULD
The classic chemotherapeutic agents are relatively non specific toxins that function by killing or at least seriously injuring cells. These agents cause significant toxicity to patients because all or most of the cells in the body are injured by these drugs. A successful chemotherapeutic agent kills cancer cells a little better than it kills normal cells.

CHEMOTHERAPY MAKING A CANCER COMPLETELY DISAPPEAR IS RARE
One of the real negative aspects of chemotherapy is that all patients receiving a drug experience toxicity which may be life threatening, but only a minority of patients with cancer will actually have treatment make the tumor regress. Having chemotherapy make a cancer completely disappear with treatment with the therapy producing a CR or complete response, is rare. The final phase III trials required to show that a new treatment is equal to or superior to a standard therapy, require hundreds of patients most of whom will be made sick by the therapy but not get any anti-tumor benefit.

CLASSIC CHEMOTHERAPY PRODUCES UNWANTED ADDITIONAL EFFECTS
Finally since classic chemotherapy agents are toxins they may produce late effects such as second cancers and major organ (bone marrow, kidney, liver, lung, etc.) damage in patients who receive treatment and or cured of their original cancers. So the bottom line with classic chemo is that these are agents that are always toxic, rarely curative, require hundreds of patients on clinical trials to demonstrate efficacy and may result in serious late effects.

Recently this paradigm of toxic relatively ineffective cancer therapies is changing. Because of increased knowledge of molecular biology and molecular genetics, more specific targeted therapies that are less toxic to normal cells are being developed. Some dramatic improvements in survival have been reported with such treatments.

IN TARGETED THERAPIES, ONLY CANCER CELLS ARE DAMAGED
AND NORMAL CELLS ARE SPARED

The key factors that make targeted cancer therapies and immunotherapy different from and in theory superior to chemotherapy are that these treatments dependent upon specific anti-tumor effects. In other words in the ideal situation only  the cancer cells are injured or killed with a targeted approach or an immunotherapy approach. Thus if a target exists only in tumor cells or is over expressed in tumor cells, then a targeted therapy only affects the cancer cell and does minimal if any damage to normal cells. Ideally the result is tumor death and no normal cell toxicity. Likewise with immunotherapy, the only cells damaged would be the cells (tumor cells) carrying the antigen or marker that the immune system recognizes. Again the result is that cancer cells are damaged and normal cells are spared.

TARGETED THERAPIES ARE MORE EFFICIENT AND LESS TOXIC
The factor to keep in mind is that the clinical development of more targeted therapies should clearly be much more efficient than development of chemotherapy. Only patients with the specific target are entered in clinical trials so the likelihood of benefit is increased. Targeted or immunotherapeutic treatments may be active against the tumor at dose levels that are minimally toxic. Thus small targeted relatively non toxic trials may be used in development of newer approaches to cancer treatment.

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