Business Insight presented by Arlington Dermatology Safety, Benefits, and Risk in Clinical Trials It is obvious that everyone wants to be healthy. It is also obvious that, when a disease strikes, we all want a cure or treatment. We also want that treatment to be safe and effective. How can it happen? First, we need to take care of our own self and our bodies to maintain wellness. Quality nutrition, sleep, exercise, and positive attitude help us maintain good health. Easier said than done, you will say. True. Secondly, you need to have a trusted and well-prepared doctor or doctors to take care of you when you do get sick. Preferably, you should also have good insurance. Again, easier said than done. True. And thirdly, we need medicines.We need them to treat us because home remedies do not work in most cases. We need medicines that are safe to use, effective to treat a disease, and have none or few side effects. Again, easier said than done. So why am I saying all of it? It is variations in priorities. Mostly due to the challenging to be sick. It is sometimes healthcare systems differences, but it is not difficult to find a good doctor. And it is the rare for these agencies to share inspections most challenging project to be sure that and information about drugs under the our new prescriptions will do no harm. The approval process. best way to make sure that we maximize our knowledge and benefits from any reporting adverse events, deaths, and all treatment is to search information about other safety information on all existing and medications in FDA registration portal and approved drugs. MedWatch is an internal on www.clinicaltrials.gov. As much as some of you may avoid any of 'black labels' that must be added to the government control or assistance, FDA prescription insert for all these events. and its role reaches far beyond normal government functioning. Under FDA, all researchers are a part of GCP, Good Clinical Misinformation and misleading come Practice, and the inspections of drugs pre- from uncontrolled and wide open and approval are crucial in protecting rather than controlling. FDA is a part of a global system of with no accountability. FDA does not do organizations, together with European Union Agency and some additional Asian changing, good sourcing of information is and Australian formal institutions, all of the only information to trust. them often working together to allow some drugs to be approved for use or not. topics about clinical trials to make sure Safety is often a common goal and the ratio we explain and educate our patients and of benefits versus risk is followed equally readers about this significant issue. Easier everywhere. Often, if there is no established said than done is very important to be said. treatment, emergency approvals are used until formal due diligence is conducted for a full approval. There might be some In addition, the industry must continue medical format, but FDA maintains a listing It is much more reliable and safer to research FDA website than social media. unregulated world of social media, in which people can post anything and everything that. And with medical science constantly In upcoming weeks, I will return to some Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight presented by Arlington Dermatology Safety, Benefits, and Risk in Clinical Trials It is obvious that everyone wants to be healthy. It is also obvious that, when a disease strikes, we all want a cure or treatment. We also want that treatment to be safe and effective. How can it happen? First, we need to take care of our own self and our bodies to maintain wellness. Quality nutrition, sleep, exercise, and positive attitude help us maintain good health. Easier said than done, you will say. True. Secondly, you need to have a trusted and well-prepared doctor or doctors to take care of you when you do get sick. Preferably, you should also have good insurance. Again, easier said than done. True. And thirdly, we need medicines.We need them to treat us because home remedies do not work in most cases. We need medicines that are safe to use, effective to treat a disease, and have none or few side effects. Again, easier said than done. So why am I saying all of it? It is variations in priorities. Mostly due to the challenging to be sick. It is sometimes healthcare systems differences, but it is not difficult to find a good doctor. And it is the rare for these agencies to share inspections most challenging project to be sure that and information about drugs under the our new prescriptions will do no harm. The approval process. best way to make sure that we maximize our knowledge and benefits from any reporting adverse events, deaths, and all treatment is to search information about other safety information on all existing and medications in FDA registration portal and approved drugs. MedWatch is an internal on www.clinicaltrials.gov. As much as some of you may avoid any of 'black labels' that must be added to the government control or assistance, FDA prescription insert for all these events. and its role reaches far beyond normal government functioning. Under FDA, all researchers are a part of GCP, Good Clinical Misinformation and misleading come Practice, and the inspections of drugs pre- from uncontrolled and wide open and approval are crucial in protecting rather than controlling. FDA is a part of a global system of with no accountability. FDA does not do organizations, together with European Union Agency and some additional Asian changing, good sourcing of information is and Australian formal institutions, all of the only information to trust. them often working together to allow some drugs to be approved for use or not. topics about clinical trials to make sure Safety is often a common goal and the ratio we explain and educate our patients and of benefits versus risk is followed equally readers about this significant issue. Easier everywhere. Often, if there is no established said than done is very important to be said. treatment, emergency approvals are used until formal due diligence is conducted for a full approval. There might be some In addition, the industry must continue medical format, but FDA maintains a listing It is much more reliable and safer to research FDA website than social media. unregulated world of social media, in which people can post anything and everything that. And with medical science constantly In upcoming weeks, I will return to some Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net