Business Insight Decoding Clinical Research, Part 2 Many of you heard comments that medications are developed for too long due to a very demanding process from the government agency, Food and Drug Administration. The process is truly demanding, but it is not a reason for the lengthy delays. FDA has a huge responsibility of approving the drugs that are for a large public usage. There will be people prescribed that new medicine who may have multiple health issues. They may have allergies. They may take some other drugs that are possibly in conflict with the new drug. FDA issues a label that must address all those problems. How do they get that information? They get it from the process of conducting compliant clinical studies that deliver proper and accurate data. FDA is not alone in this process: most of the systemic drugs these days are developed globally, in cooperation with European Union, Canada, Australia, Japan, and Asia. All these geographic locations have their own regulatory authorities in the governments, and they all follow the same rules of safety and novelty brought to the markets. I could not express more that these rules are crucial and cannot be overestimated for our own safety. There have been too many cases of speedy approvals based on defective data that ended up badly and caused more harm than benefit. The risk in clinical researc is clear: the drugs must be novel; they must be more effective or not less effective that any predeceasing drug of the same indication and must deliver more benefit than harm. All the regulatory authorities around the world follow that main rule. presented by Arlington Dermatology So, what is the obstacle of fast development? There are many. Pharmaceutical companies must design clear and safe protocols to be followed by doctors. They must put together a team of scientists, doctors, vendors, and the process is long and difficult. In many cases, they as a pharmaceutical company have an oversight of the process but they delegate the actuali research to, so called, CROS, Clinical Research Organizations. These are not pharmaceutical companies and they do not own the patents of the drugs. They are management companies, running the show, better or worse, but they do not have patients and they do not own new drugs. Some of them are huge, they have 60-100 locations around the world, and it is not uncommon for the studies conducted in the US to be managed remotely from Romania or Spain, or Brazil. The effectiveness of CROS could be a separate story, but they are frequently not managed well. They lack proper personnel, hire employees remotely, often without checking references, and often with no prior experience demanded by the study. They can create a lot of headaches. Their responsibilities vary from minimal to total management, including selecting other vendors like laboratories. Their main role is, however, to find doctors with patients who are willing to volunteer in clinical research. And that process is responsible for the long, long months. Some studies enroll in 3-4 months, some more than 2 years. Depending on that enrollment and the quality of data collected, the studies can run for years before they are ready to be submitted to FDA for approval. It is not unique that data quality is so poor that pharmaceutical companies must re-do the study, usually managed by a different CRO. Recently, we received a notice from one of the pharma that their drug is being delayed by FDA due to a non-compliant manufacturing. The drug is good and safe, but the manufacturing process was lacking proper quality and was not ready for a safe production. As you can see, safety is a matter of complex activities and quality of actions throughout many components. FDA has a very small budget for inspecting it all. But they do random inspections, and they stop what may not be safe for us. 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 2 Many of you heard comments that medications are developed for too long due to a very demanding process from the government agency , Food and Drug Administration . The process is truly demanding , but it is not a reason for the lengthy delays . FDA has a huge responsibility of approving the drugs that are for a large public usage . There will be people prescribed that new medicine who may have multiple health issues . They may have allergies . They may take some other drugs that are possibly in conflict with the new drug . FDA issues a label that must address all those problems . How do they get that information ? They get it from the process of conducting compliant clinical studies that deliver proper and accurate data . FDA is not alone in this process : most of the systemic drugs these days are developed globally , in cooperation with European Union , Canada , Australia , Japan , and Asia . All these geographic locations have their own regulatory authorities in the governments , and they all follow the same rules of safety and novelty brought to the markets . I could not express more that these rules are crucial and cannot be overestimated for our own safety . There have been too many cases of speedy approvals based on defective data that ended up badly and caused more harm than benefit . The risk in clinical researc is clear : the drugs must be novel ; they must be more effective or not less effective that any predeceasing drug of the same indication and must deliver more benefit than harm . All the regulatory authorities around the world follow that main rule . presented by Arlington Dermatology So , what is the obstacle of fast development ? There are many . Pharmaceutical companies must design clear and safe protocols to be followed by doctors . They must put together a team of scientists , doctors , vendors , and the process is long and difficult . In many cases , they as a pharmaceutical company have an oversight of the process but they delegate the actuali research to , so called , CROS , Clinical Research Organizations . These are not pharmaceutical companies and they do not own the patents of the drugs . They are management companies , running the show , better or worse , but they do not have patients and they do not own new drugs . Some of them are huge , they have 60-100 locations around the world , and it is not uncommon for the studies conducted in the US to be managed remotely from Romania or Spain , or Brazil . The effectiveness of CROS could be a separate story , but they are frequently not managed well . They lack proper personnel , hire employees remotely , often without checking references , and often with no prior experience demanded by the study . They can create a lot of headaches . Their responsibilities vary from minimal to total management , including selecting other vendors like laboratories . Their main role is , however , to find doctors with patients who are willing to volunteer in clinical research . And that process is responsible for the long , long months . Some studies enroll in 3-4 months , some more than 2 years . Depending on that enrollment and the quality of data collected , the studies can run for years before they are ready to be submitted to FDA for approval . It is not unique that data quality is so poor that pharmaceutical companies must re - do the study , usually managed by a different CRO . Recently , we received a notice from one of the pharma that their drug is being delayed by FDA due to a non - compliant manufacturing . The drug is good and safe , but the manufacturing process was lacking proper quality and was not ready for a safe production . As you can see , safety is a matter of complex activities and quality of actions throughout many components . FDA has a very small budget for inspecting it all . But they do random inspections , and they stop what may not be safe for us . Michael Bukhalo , MD Arlington Dermatology 5301 Keystone Court Rolling Meadows , IL 60008 Tel . 847 392 5440 | www.arlingtondermatology.net