Business Insight Decoding Clinical Research, Part 1 Most people do not really investigate how their prescriptions fix their medical problems. First of all, they trust their doctors and assume they know better how to address their health issues. Secondly, small print inserts in every drug package do not really invite reading or investigating. Unless they had some unwanted experience in the past, they take the medications as prescribed and hope to see results soon. Before that medication made it to the pharmacy, there was more than likely a long way of checks and trials to make sure it really benefits patients and does not harm them. What is that long way about and how does it really work? presented by Arlington Dermatology A huge number of medical discoveries are made in the National Institute of Health. It is a government agency, with years of experience and massive contacts globally, full of scientists with different backgrounds, working in the labs globally to keep up with the ever-changing medical environment. NIH comes with discoveries but very often does not have budgets to push further development. Thus, they seek partnerships with the private pharmaceutical industry to develop the final product. Certainly, there is a small number of novel molecules that are discovered and developed in the private pharmaceutical industry but that is not a large majority. After the initial discovery, the pre-clinical trials start. They are done on animals. They are much less regulated than the human level of development and we often hear some bad news about the treatments that might have harmed animals. As much as we dislike it, there is not much we can do about it, except the fact that animals used in studies should not suffer neglect and pain. When animals' pre-clinical studies show promising results, human level studies are authorized by the Food and Drug Administration, another very crucial government agency. They begin with phase 1 trials, usually done in small groups and on volunteers who do not have any particular diagnosis. This phase is mostly looking at safety and toxicity of any new drug. Successful phase 1 moves the drug to phase 2, which already targets the population of a certain indication or diagnosis. Still done in smaller groups, up to 200 patients, the goals are to monitor safety and also observe efficacy or how well the drug helps. In the very final phase, phase 3, the trial groups are larger, often going up to 2000 patients, and they focus on continuing long-term safety and efficacy. The longer it takes to find volunteers for the trials, the longer the process of development is. The more complex the systems used in the trials, data collection, labs, additional testing, the longer the approval process will take. This should bring you to a very simple conclusion: there are many players who must work together in order to make it a full success and safe outcome. This is absolutely true. The FDA stands over all these activities and sets the standards for them. They are called Good Clinical Practice or GCP. All participants and all players must abide by these rules. In today's global medical development, all the countries follow almost identical rules and regulations and have agencies similar to the FDA. Their role cannot be overestimated. It means your safety. In the next few weeks, I will continue introducing you to this interesting topic in more detail. I hope it will help you to not only understand the process better but also become an educated volunteer of our clinical trials or other research projects. This simply means building safe future medical assistance. Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight Decoding Clinical Research , Part 1 Most people do not really investigate how their prescriptions fix their medical problems . First of all , they trust their doctors and assume they know better how to address their health issues . Secondly , small print inserts in every drug package do not really invite reading or investigating . Unless they had some unwanted experience in the past , they take the medications as prescribed and hope to see results soon . Before that medication made it to the pharmacy , there was more than likely a long way of checks and trials to make sure it really benefits patients and does not harm them . What is that long way about and how does it really work ? presented by Arlington Dermatology A huge number of medical discoveries are made in the National Institute of Health . It is a government agency , with years of experience and massive contacts globally , full of scientists with different backgrounds , working in the labs globally to keep up with the ever - changing medical environment . NIH comes with discoveries but very often does not have budgets to push further development . Thus , they seek partnerships with the private pharmaceutical industry to develop the final product . Certainly , there is a small number of novel molecules that are discovered and developed in the private pharmaceutical industry but that is not a large majority . After the initial discovery , the pre - clinical trials start . They are done on animals . They are much less regulated than the human level of development and we often hear some bad news about the treatments that might have harmed animals . As much as we dislike it , there is not much we can do about it , except the fact that animals used in studies should not suffer neglect and pain . When animals ' pre - clinical studies show promising results , human level studies are authorized by the Food and Drug Administration , another very crucial government agency . They begin with phase 1 trials , usually done in small groups and on volunteers who do not have any particular diagnosis . This phase is mostly looking at safety and toxicity of any new drug . Successful phase 1 moves the drug to phase 2 , which already targets the population of a certain indication or diagnosis . Still done in smaller groups , up to 200 patients , the goals are to monitor safety and also observe efficacy or how well the drug helps . In the very final phase , phase 3 , the trial groups are larger , often going up to 2000 patients , and they focus on continuing long - term safety and efficacy . The longer it takes to find volunteers for the trials , the longer the process of development is . The more complex the systems used in the trials , data collection , labs , additional testing , the longer the approval process will take . This should bring you to a very simple conclusion : there are many players who must work together in order to make it a full success and safe outcome . This is absolutely true . The FDA stands over all these activities and sets the standards for them . They are called Good Clinical Practice or GCP . All participants and all players must abide by these rules . In today's global medical development , all the countries follow almost identical rules and regulations and have agencies similar to the FDA . Their role cannot be overestimated . It means your safety . In the next few weeks , I will continue introducing you to this interesting topic in more detail . I hope it will help you to not only understand the process better but also become an educated volunteer of our clinical trials or other research projects . This simply means building safe future medical assistance . Michael Bukhalo , MD Arlington Dermatology 5301 Keystone Court Rolling Meadows , IL 60008 Tel . 847 392 5440 | www.arlingtondermatology.net