Business Insight Decoding Clinical Research, Part 3 We already established in the previous articles that drug development is a complex process and full of participants, some more and some less vested in that process. Pharmaceutical companies are hugely vested because they place a lot of funds into the development, they want to keep their new drug pipeline active, and they want to recover the cost by selling the new medication. Doctors are very much vested and so are their patients. We all want newer and better drugs, and we all want safe medicine. If doctors have no tools to practice safe medicine, they just do not do well in all aspects of their medical practice. Having unsafe medication puts patients at risk and doctors at risk as well. But there are many players in that process that do not see the impact of poor quality. Data managers and companies are just computer people, often hired from far countries, often working thousands of miles remotely, and they just do not pay much attention to common sense or clinical process. They want their programs to be sold at the highest possible price and gain as many contracts as possible. Laboratories process blood and tissue samples for the research but there is no direct correlation between them and patients. While wrong and mistaken results do not happen often, the timing of processing, reporting, and designing the process are often too poorly delivered. Usually, pharmaceutical companies directly managing their trials do much better selecting the vendors and keeping them in line with quality performance. presented by Arlington Dermatology So, where does it put the doctors' researchers? First and foremost, doctors who do clinical research must be vocal and report each and every quality issue to the pharmaceutical sponsors, with full documentation of where the problems occur. Secondly, they must be selective in the process of signing agreements for the studies that project problems. Often, it is all visible early and doctors can always pull out from discussions. And finally, doctors must keep their own performance up to the highest standards of drug development. This means that the safety and benefits of the patients must always define their studies and the risk must be minimized. Only then, their patients can trust them and be a part of this crucial process, needed for all of us to continue. There is one additional component of drug development that contributes to sometimes tricky outcomes. It is associated with our healthcare system in general. In a market economy of the US, drugs are a part of price control associated with demand, like any other product. There is no protection for patients from being taken advantage of and not able to buy crucial medication due to the price tag. It can be truly unfair and immoral in the long run, but this is how our system works. In the countries of European Union or Japan, where healthcare is a social benefit to all, it is the government who controls the pricing and may disapprove a drug that is simply too costly, with too little benefit. It totally makes sense, but it would require a huge overhaul of our economic ideology regarding healthcare. But it certainly is worth a conversation and discussion. 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 3 We already established in the previous articles that drug development is a complex process and full of participants , some more and some less vested in that process . Pharmaceutical companies are hugely vested because they place a lot of funds into the development , they want to keep their new drug pipeline active , and they want to recover the cost by selling the new medication . Doctors are very much vested and so are their patients . We all want newer and better drugs , and we all want safe medicine . If doctors have no tools to practice safe medicine , they just do not do well in all aspects of their medical practice . Having unsafe medication puts patients at risk and doctors at risk as well . But there are many players in that process that do not see the impact of poor quality . Data managers and companies are just computer people , often hired from far countries , often working thousands of miles remotely , and they just do not pay much attention to common sense or clinical process . They want their programs to be sold at the highest possible price and gain as many contracts as possible . Laboratories process blood and tissue samples for the research but there is no direct correlation between them and patients . While wrong and mistaken results do not happen often , the timing of processing , reporting , and designing the process are often too poorly delivered . Usually , pharmaceutical companies directly managing their trials do much better selecting the vendors and keeping them in line with quality performance . presented by Arlington Dermatology So , where does it put the doctors ' researchers ? First and foremost , doctors who do clinical research must be vocal and report each and every quality issue to the pharmaceutical sponsors , with full documentation of where the problems occur . Secondly , they must be selective in the process of signing agreements for the studies that project problems . Often , it is all visible early and doctors can always pull out from discussions . And finally , doctors must keep their own performance up to the highest standards of drug development . This means that the safety and benefits of the patients must always define their studies and the risk must be minimized . Only then , their patients can trust them and be a part of this crucial process , needed for all of us to continue . There is one additional component of drug development that contributes to sometimes tricky outcomes . It is associated with our healthcare system in general . In a market economy of the US , drugs are a part of price control associated with demand , like any other product . There is no protection for patients from being taken advantage of and not able to buy crucial medication due to the price tag . It can be truly unfair and immoral in the long run , but this is how our system works . In the countries of European Union or Japan , where healthcare is a social benefit to all , it is the government who controls the pricing and may disapprove a drug that is simply too costly , with too little benefit . It totally makes sense , but it would require a huge overhaul of our economic ideology regarding healthcare . But it certainly is worth a conversation and discussion . Michael Bukhalo , MD Arlington Dermatology 5301 Keystone Court Rolling Meadows , IL 60008 Tel . 847 392 5440 | www.arlingtondermatology.net