Potential and Capabilities of the Clinical Research Sector
Clinical research organisations, play an essential role within the drug development process. From large international firms, to smaller niche companies, clinical research organisations are relied upon by the pharmaceutical manufacturers to conduct clinical trials.
The patents due to expire on a number of blockbuster drugs in the coming months mean that the pharmaceutical industry is likely to refocus its drug development strategies.
With uncertainty still surrounding the global economy, drug manufacturers are likely to look to clinical research organisations to provide the expertise needed to get their products to market, in both a timely and safe manner.
Figures from Tufts Center for the Study of Drug Development show that clinical trials conducted by outside organisations are completed 30 per cent faster than those completed in-house.
Projected revenue of $20 billion(£12.6 billion) is expected in 2010 alone for the sector, according to the Association of Clinical Research Organizations (ACRO). This accounts for one-third of research and development spend in the pharmaceutical and biotechnology industries.
In 2008 alone, ACRO members conducted more than 9,000 clinical trials involving over two million human participants.
Major areas of interest for clinical research organisations include oncology, accounting for 18 per cent of all clinical trials, central nervous system disorders (15 per cent), cardiovascular disease (10 per cent) and infectious disease (10 per cent), the ACRO calculates. Other popular fields include infectious disease and metabolic disease. Within the field of oncology, the most common areas for drug development were non-small cell lung cancer, breast cancer, lung cancer, prostate cancer, and leukaemia.
The global reach of clinical research organisations is also expanding, as drug development increasingly moves from traditional centres to emerging economies where costs are cheaper.
There are those who suggested the price of clinical trials in China, which is expected to be the third largest pharmaceutical market in the world by 2013, is up to 30 per cent cheaper than in Western countries.
India is another growing market, where, by the year 2012, the clinical trial industry in the country is expected to be worth $630 million, according to figures from companiesandmarkets.com.
Figures from clinicaltrials.gov show that, while more than half of clinical trials are being carried out in the United States, almost a quarter are now taking place in Asia, Latin America, Africa and Australia.
According to the ACRO, its members now conduct clinical trials in more than 115 countries worldwide.The organisation said that, due to the growing global presence of clinical research organisations, it supports increased funding for regulatory authorities to conduct inspections and ensure International Conference on Harmonization's Good Clinical Practices (GCP) guidelines are being followed.
Patient safety and regulatory enforcement
One of a clinical research organisation's highest responsibilities is to the human subjects participating in the trials, while continuing to protect the integrity of the data they collect.
Phase one in small-scale trials can include as few as 20 healthy participants, while, by the time clinical trials reach phase three, clinical research organisations could be responsible for thousands of human subjects.
Strong regulatory frameworks are needed in all countries where clinical trials are carried out to ensure organisations are acting in accordance with international guidelines.
In the United States, the Food and Drugs Administration (FDA) is the body responsible for administering GCP and Human Subject Protection (HSP) guidelines, while in Europe, this task falls to the European Medicines Agency.
The need for regulatory enforcement is coupled with a requirement for clinical research organisations to train their staff appropriately so they understand how to sufficiently protect their human subjects.