Development of New Drugs for Cancer Patients - Research Paper Example

? Development of New Drugs for Cancer Patients Development of New Drugs for Cancer Patients Over the years, cancer has been seen as a highly complex, ever-present and devastating disease that is incurable. More significantly, cancer has been attributed to cause millions of new diagnoses worldwide besides the high record of deaths associated with cancer complications. More so, the current medical research centers remain revolutionized with increased technological developments for new drugs (Savage, 2010). As the medical research centers, remain interested in innovations of new drugs for cancer treatment it would be ideally effective and considerate to assist many patients who have been diagnosed with cancer. Considerably, it is essential to describe the economic issues, and special health needs of populations who are suffering from cancer. In addition, it is critical to understand the benefits of the program to both the general community and patients suffering from cancer. Economic Issues with Development of New Drugs for Cancer Patients More than often, the development of new drugs for cancer patients has brought about economic issues considering the budget constraints that surround the finances in the health sectors. Nonetheless, the decision makers involved in health related issues are faced with challenges as they strive to maintain balance within a limited budget as they consider the long-term economic benefits of introducing and using new technologies (Savage, 2010). As a result, the development of new drugs in the health sector ensure that the decision makers make use of cost-effectiveness analysis as they remain accountable for their decisions based on viability and sustainability of such projects. Therefore, the government and other corporate sectors interested in investing in the health sector should carry out an economic evaluation considering the issue of cost effectiveness that influence the reimbursement decision-making process based on the prices of the new drugs and expected sales. The ability of the patient to access the new cancer drugs depends on the availability of appropriate funding by the interested parties including clinicians, payers, policy makers, and society. As one of the largest selling drugs, it is economically viable to come up with a more effective cancer drug, as emerging oncology treatments are not resistant in their overall treatment value (Savage, 2010). More notably, as pharmaceutical companies dealing with drugs for diseases such as cancer are trying to cope with a rapidly changing world, investment in new drugs the global economy allows companies to merge for ultimate survival. Special Needs of the Population Using Cancer Drugs More importantly, with the increased levels in patients suffering from cancer, it is critical to consider that there is a special need for invention of new drugs that ensure treatment is availed. Just as any other risky health complications, cancer cases have been on the increase leading to urgent priority as one of the major health issues (American Academy of Family Physicians, 2011). This is because, consideration of the risk factors and conditions of earlier interventions in treatment of cancer patient in the earlier and late stages recommend new drugs as the treatment options available to patients that are associated with risks and benefits. Being a disease considered to be incurable new drugs to cure, cancer cases allow for effective prevention and control to ascertain substainable treatment. Process of Development of New Drugs for Cancer Patients Just as development of new products in the market involve properly guided guidelines the process of developing the new cancer drug follows medically prescribed steps before it is eventually released for use. More significantly, as any other new prescription drugs the cancer drug should be approved by the Food and Drug Administration (FDA), as it ensures that the process of developing and bringing new drugs to market remain important for primary care physicians to understand its administration and reduce adverse effects (Lipsky & Sharp, 2001). Non-Clinical Studies First, it is necessary to carry out non-clinical studies of the total population of patients who are expected to use the drug. This therefore, allows for determination of the duration of time is which the patient will gain total exposure to the new drug. Thereafter, it is critical to evaluate the characteristics of the drug in order to determine the whether it is used for long half life and biotechnology products used in the drug (Lipsky & Sharp, 2001). It is also essential to consider the types of cancer condition targeted for treatment ranging from breast, lung, and stomach among other forms of cancer. Therefore, before the new drug is used, routine of administration besides its safety in use in special populations more especially ranging from ages, pregnant and lactating women of childbearing potential is tested with a focus on safety and pharmacology. (Gale Encyclopedia of Cancer, 2002) Safety Studies After the non-clinical trials, it is essential to undertake the safety studies to examine the effectiveness of the compounds found in the new drug on humans. Nonetheless, it is vital that the first studies conducted on humans should involve careful administration of the dose that is determined through careful examination of the preconditioned non-clinical pharmacokinetic, pharmacological and toxicological evaluations as stipulated for health reasons (Lipsky & Sharp, 2001). More so, the initial non-clinical studies conducted on the new drug should support selection of an initial safe human dose that allows for safe duration of exposure. In addition, the findings of the non-clinical studies should give information based on physiological and toxicological effects of the new cancer drug. Pharmacological and Pharmacokinetic Studies This studies remain relevant in the development of a new drug as it forms the basis and direction upon which the clinical exploration and development of the new product takes place. It involves consideration of mechanisms of action based on pharmacological principal effects. In addition, this stage involves analysis of the dose-response relationships with the duration of action in the safety study (Lipsky & Sharp, 2001). More so, this level of study gives the potential clinical routes of administration besides the systemic general pharmacology effects of the drug. After this studies, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) based on all information of the testing phase before finally undertaking the marketing of the drug. Post-Marketing Studies After presenting the application to the Food and Drug Administration (FDA) and it gains approval if it is accepted it can be distributed to the market. Nonetheless, after several years of use the manufacturer of the drug carries out additional marketing studies to consider the viability of the innovation of the new cancer drug (Lipsky & Sharp, 2001). This involves assessing its significance in reduction of risks among patients suffering with cancer as they have prolonged life. More than often, at this stage marketers apply marketing strategies like packaging as shown below. (Gale Encyclopedia of Cancer, 2002) Benefits of the Development of New Drugs for Cancer Patients With the reality that people suffering from cancers are suffering because of lack of treatment advances in technology to develop, new drugs give them hope of survival. In addition, those related to patients with cancer find new forms of treatment beneficial, as they remain cheap for those with limited cover towards drug expenses (Michael & Greenberg, 2000). More so, new drugs the cancer patients new for medication that increase the probability for improvement as they find better diagnosis, treatment, and prevention of cancer. References American Academy of Family Physicians. (2011). Comments requested in the Federal Register for the development of guidance for Health Risk Assessments (HRAs). Retrieved from http://www.cdc.gov/policy/opth/hra/comments.pdf on 2 May 2012 Gale Encyclopedia of Cancer. (2002). Drug Resistance. Retrieved from http://www.encyclopedia.com/topic/drug_resistance.aspx on 2 May 2012. Lipsky, M., & Sharp, L. (2001). From Idea to Market: The Drug Approval Process. JABFP. 14(5): 362-367 Michael D. & Greenberg, P. (2000). Aids, experimental drug approval, and the FDA new drug screening process. Legislation and Public Policy, 3:295-350 Savage, P. (2010). Development and economic trends in cancer therapeutic drugs in the the UK from 1955 to 2009. J Oncol Pharm Pract, 18(1). Read More