Balancing Medical Dermatology and Clinical Trials
Transcription
Balancing Medical Dermatology and Clinical Trials
March 2014 Balancing Medical Dermatology and Clinical Trials Rod Kunynetz, MD, FRCPC One of the great advantages of dermatology is that it is a multifaceted specialty. It includes medicine, surgery, cosmetics, immunology, dermatopathology and infectious diseases. Fortunately, most if not all, of these paths include the opportunity for research. Probably the most common in Canada is that of clinical research, ranging from phase one to phase four trials. Being involved in clinical trials has its great rewards, but also has its disadvantages. It is a fine balance between the usual dermatological patients requiring medical or surgical care and those that have been enrolled in trials. Those involved in clinical trials quickly learn that scheduling becomes a nightmare; trying to balance both sides of the equation. The clinical trials themselves and the investigator meetings are very time consuming. They are unpredictable as to how many, how often and the ebb and flow of new trials are very erratic. Often investigator meetings are scheduled several months ahead only to be cancelled and/or rescheduled for a later date. Difficulties often arise in trying to attend these meetings, usually held in the southern United States, rarely in Europe or western US or Canada. Scheduling routine medical patients and even the clinical trial patients (who are to see you by a certain date) around them is difficult because it means cancellations in order to travel. Fortunately most of the pharma community has realized that such travel infringes not only on routine medical income for a dermatologist, but also presents headaches with clinical trial patients being seen within their proper follow-up scheduling windows. The community has thus responded in scheduling investigator meetings, for the most part, on weekends. This certainly does lead to a very long week for the investigator with the weekends being spent from morning to evening at the meeting hall and then travel back home. There are thus many hidden costs to being involved with clinical trials which the novice quickly learns. Among the advantages is that one becomes a much more complete physician; again rediscovering the stethoscope and the otoscope and “dusting off” the black medical bag which many of us have stored over the last several decades. Having access to novel therapeutic modalities, usually pharmaceutical, is a great advantage as we become very familiar and comfortable with them before their approval and introduction to the general medical population. One can also give patients hope for better outcomes given the prior familiarization with these modalities. In general I believe you become a better physician. Scheduling can be approached in a number of ways. The most common is intertwining patients for clinical trials with those of your general medical dermatological practice. Some dermatologists will segregate, for instance, seeing their dermatological patients in the morning and the clinical trial patients in the afternoon. The former is usually a steady stream; however the afternoon clinical trial patients may give you an overfull schedule at some times of the year and at others, a sparser pace. The use of staff also can be varied if one does segregate the morning and the afternoon patients. The same staff can be used in the morning and afternoon. However the intertwining of patients does certainly require a dedicated clinical trial staff. Just as with any medical procedure one does need to rely heavily on the dedication and the efficiency of this staff; ultimately any misadventures will end up in the lap of the dermatologist. Despite all the above potential headaches, I feel that clinical trials are very rewarding for all involved: the physician, the staff, the patient, and the pharma industry. Editorial Board / Conseil de rédaction National editor/ Rédacteur en chef Regional editors / Rédacteurs régionaux Robert Jackson, MD Ottawa, ON Paul Kuzel, MD Edmonton, AB Charles W. Lynde, MD Markham, ON Benjamin Barankin, MD Toronto, ON Ian Landells, MD St. John’s, NL G. Daniel Schachter, MD Toronto, MD Executive director / Directeure générale Marc Bourcier, MD Moncton, NB Catherine McCuaig, MD Montréal, QC Victoria Taraska, MD Winnipeg, MB Chantal Courchesne Ottawa, ON Peter R. Hull, MD Saskatoon, SK Kathleen Moses, MD Ottawa, ON Catherine Zip, MD Calgary, AB Statements and opinions expressed in the CDA eBulletin reflect the opinions of the authors and not necessarily the CDA. The CDA does not assume responsibility or liability for damages arising from errors or omissions or from the use of information or advice contained in the CDA eBulletin articles or letters. The Canadian Dermatology Association eBulletin is issued monthly as a forum for Association news, information of interest to members and for members’ opinions. Please notify the Executive Director of any change in address. L’Association canadienne de dermatologie publie chaque mois le bulletin électronique en tant que forum de nouvelles de l’Association, d’informations qui pourraient intéresser nos membres, ainsi que pour Les textes et les opinions publiés dans le bulletin électronique de l’ACD reflètent les points de vue de leurs auteurs et non pas nécessairement ceux de l’ACD. 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