Fighting the Battle Against Lung DiseaseWed, 09/09/2015 - 11:47
As chronic and degenerative diseases currently play a major role in big pharmaceutical companies’ innovative portfolios, the need to conduct clinical trials for such diseases increases. In Mexico today, the risk of chronic and degenerative diseases has overtaken the risk posed by contagious diseases and infections, and respiratory disease is no exception. Tobacco smoking has a prevalence of 14 to 20% in the Mexican population, which equates to 20 million smokers, and is directly related to cardiovascular and cerebrovascular diseases, diabetes, and chronic obstructive pulmonary disease (COPD). Leading to serious complications such as emphysema, chronic bronchitis, and bronchiolitis, COPD is already the fourth most common cause of death in Mexico. One company involved in combatting these diseases in Mexico is Centro Respiratorio de Mexico (CRM), specializing in clinical trials involving respiratory and pulmonary function.
CEO Dr. Raúl Sansores explains “clinical trials can be a promising alternative for patients who do not have access to private or public healthcare services, especially when dealing with chronic diseases that incur lifelong expenses.” In this way, the clinical trials industry helps the healthcare sector in lessening the burden of disease, efforts that can be further supported by increasing quality standards in Mexican clinical research sites. Dr. Sansores is an advocate of investment in safety procedures and adopting the quality and commitment that exists in labs in the US and Europe, so CRM was recently certified to ISO 9001. According to Dr. Sansores, “taking risks when conducting clinical trials can compromise patient safety, so this quality accreditation is a worthwhile investment in that it guarantees all operations within the site are standardized, monitored, and effectively managed.”
With the recent efforts in reviewing the Mexican Official Norm NOM-012-SSA3-2012, focus is increasingly being placed on refining the quality requirements for conducting clinical trials and Dr. Sansores describes this development as a necessary step. However, he believes that the approval process for study protocols could be further improved. This, along with sites’ certification, could strengthen Mexico’s competitiveness in terms of attracting multinational clinical trials to Mexico. Clinical trials do not only benefit the patient, but bring economic advantages to the country, with the creation of jobs and foreign investment. Therefore, this should be a significant motivation for collaboration between the regulatory authorities, pharmaceutical companies, and research centers.
The work of Dr. Sansores also includes developing a cutting edge smoking cessation program which is tailored around the individual personality traits of each patient. As a general rule, approaches to smoking cessation take a blanket approach and “more effective results will be seen if programs are tailored to meet patients’ needs on a personal basis,” explains Dr. Sansores. There are key differences among patient genotypes which account for varying levels of neurotransmitters and behaviors and as a result, it is not appropriate to assume that a method which is successful with one patient will be equally effective with another. Ultimately, in genomics there will be a lot of opportunity for innovation of this type of tailored medicine and testing in the coming years.
Dr. Sansores is vocal in raising awareness about the dangers of smoking and the prevalence of chronic smoking-related conditions. Taking into consideration that COPD has a prevalence of 12% in smokers, CRM engaged in a mass media program calling for universal smoking cessation on November 19, coinciding with World COPD Day. On Smoking Cessation Day which falls on March 31, a number of activities are carried out in order to raise public awareness of the issue. Moreover, as COPD is an underdiagnosed disease with up to 90% of COPD patient symptoms going undiagnosed in Mexico, the clinic provides pulmonary function tests free of charge with the aim of preemptively detecting COPD.
In terms of expansion, CRM has plans in the near future to expand the research center in terms of infrastructure and staff. Developing capabilities for conducting bioequivalence studies will be a major focus and expansion into new specialized areas of study such as metabolic disorders are in the pipeline. The main goals for CRM are to increase the number of clinical trials conducted and develop partnerships for establishing new projects in different fields.