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The value of clinical trials

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Medicine Cabinet
Teodoro Padilla

IT IS ESTIMATED that the annual spending of the biopharmaceutical sector in research and development is 5.5 times higher than the defense and aerospace industries. As a result of these R&D efforts, more than 3,000 medicines are now in development for major diseases such as cancer, cardiovascular, diabetes, and HIV-AIDS. 

There are also close to 120 projects that aim to develop medicines and vaccines to address the so-called Neglected Tropical Diseases (NTDs), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) stated.

The World Health Organization (WHO) explained that NTDs is a diverse group of communicable diseases that prevail in tropical and subtropical conditions in 149 countries, including the Philippines. Examples of NTDs that are present in the country are dengue, leprosy, rabies, lymphatic filariasis, and schistosomiasis. The NTDs affect more than one billion people and cost developing economies billions of dollars every year, thus the need to prevent, manage, and eradicate them.

The average cost to research and develop each successful drug to help fight diseases is about $2.6 billion. This investment includes the cost of failures where thousands or millions of compounds are screened but only few will eventually receive regulatory approval. The overall probability of clinical success is less than 12%.

On average, it takes at least 10 years for a new medicine to complete the R&D process. It is set in motion by the discovery process, which takes three to six years to complete. During the discovery stage, researchers aim to identify a promising drug candidate to further study in the laboratory and in animal models.

Biopharmaceutical companies work hard independently and in partnership with other researchers to better understand diseases at the molecular level. Armed with more understanding about the disease, potential new medicines go through early phases of basic research, drug discovery, and pre-clinical stages.

The discovery process involves identifying potential targets and eventually narrowing it to one lead compound. A lead compound is a promising molecule that could infuence the target and, potentially, become a medicine.

Following the success of pre-clinical work, a company must file an investigational new drug application with the regulatory agency like the Food and Drug Administration. All clinical trials must also be reviewed by the institutional review board (IRB) or ethics committee (EC) at the institutions where the trials will take place with the aim of ensuring the safety of research participants. 

The quality, safety, and efficacy of medicines are primary to the drug development process. Therefore, all potential medicines must first undergo extensive studies and demonstrate that they are safe and effective for human use during clinical trials.

The publication Biopharmaceutical Research and Development: The Process Behind New Medicines, explained that the clinical trial process is both expensive and time-consuming, and ends more often in failure than success. In addition to the time spent for discovery process, the clinical development phase also takes an average of six to seven years.

The clinical trials process is an important undertaking which requires extensive infrastructure, investment, careful regulation, safety measures, and coordinated planning across stakeholders. More people are also involved including doctors, nurses, laboratory technicians, clinical trial support team members, and clinical trial managers, among others. (For more information, visit innovation.org.) 

(To be continued)

Medicine Cabinet is a column of the Pharmaceutical and Healthcare Association of the Philippines (PHAP), representing the research-based medicines and vaccines sector in the country. The author is the executive director of PHAP. E-mail the author at medicinecabinet@phap.org.ph.

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