Saturday, November 4, 2017

Overcoming Risks in Oncology Clinical Trials

Cancer research is probably the most heavily funded research branch in modern medicine, and for good reason. Nearly 40% of men and women will be diagnosed with cancer at some point in their lifetimes. However, with new medicine and technology, the number of people who are surviving cancer was nearly 14.5 million in 2014 and is expected to rise to almost 19 million by 2024. In fact, in the last decade, the overall cancer rate in the United States fell by 13%, largely due to the implementation of new treatments.

Oncology clinical trials are directly responsible for the increase in effective treatments, Clinical Research Organizations (CRO) play a key role in orchestrating these trials. There are as many kinds of cancers as there are patients, and even within cancer types, how it behaves and reacts to treatment can vary day to day. CRO's can ensure that an appropriate-sized patient pool is collected to test treatments at all stages of cancer – from the initial diagnosis to aggressive stage IV types.

CRO's are crucial in organizing oncology trials, particularly when it comes to reducing costs. According to the Tufts Center for the Study of Drug Development, nearly 60% of protocols are amended during the trial, which can be costly. CRO's can view early phase protocol holistically, particularly when multiple trials are conducted around the same time. CRO's can check to see if the early work such as animal studies and basic toxicology have been completed, or if the patient population has been selected accurately, based on particular biomarkers. A thoughtful approach in the early phases of clinical trials can save significant money in the long run, as well as build the foundation for a reliable study in the future.

CRO's can maintain a library or catalog of treatments, patients, biomarkers and data for cancer treatment. Cancer is a collection of hundreds of diseases which often change over time, leading to mutations which can result in treatment resistance. By maintaining an extensive log of analysis and resources, CRO's can make it easier for biomedical companies, doctors, and researchers to build on existing knowledge to modify treatments in response to a changing disease. CRO's establish a structure for future clinical trials.

To that end, late-stage oncology trial research is the biggest risk for pharmaceutical companies, with one study showing that these trials have only an 11 percent chance of success. CRO's can maintain up-to-date and detailed information about each trial, knowing early on how likely a drug is to be approved, which is essential for companies in making business decisions.

Pharmaceutical companies should recruit CRO's for the primary reason that they have a depth and breadth of knowledge, which is critical for treatment development. CRO's employ expert researchers who have not only therapeutic expertise but also specific clinical trial experience. They understand the role of biomarkers in research, immunotherapies and companion diagnostics, and can use this to analyze trial data efficiently and reliably. Furthermore, cancer is a global phenomenon, and patients live worldwide. A CRO has the advantage of hiring experts who understand the different standards of care around the world, which is critical when conducting a trial in another country. There are no uniform approaches to care, particularly in oncology, and CRO's will be able to readily obtain this information. 

INC Research, for instance, has the resources and expertise to ensure clinical oncology research trials are as successful as possible, without a goal to find an effective treatment for cancer, and ensure that the companies we work with meet their business and investment goals with integrity. For more information, visit: https://www.incresearch.com/our-experience/cancer-oncology-clinical-studies

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