Clinical Research Committee Survey on Challenges of Conducting Surgical Trials Results

Transcription

1 Clinical Research Committee Survey on Challenges of Conducting Surgical Trials Results

2 SURVEY RESULTS Survey population = 3500 Total responses as of 24 August 2015 = 195 Response rate = 5.6% ESSO Clinical Research Committee survey Ge nd e r: Answe r Op tio ns Male Female Pe rce nt Co unt 82.5% % 33 a nswe re d q ue stio n skip p e d q ue stio n 189 6

3 Age range 25,0% 20,0% 15,0% 10,0% over 70 5,0% Click 0,0% to edit Master subtitle style

4 Participating countries in the survey One response each Bangladesh Bosnia and Herzegovina COLOMBIA Croatia Denmark Finland Gangnam-gu IRAQ Ireland Lithuania Pakistan Russia Scotland, UK Slovakia Sweden Switzerland Turkey Ukraine VENEZUELA Yemen Russia

5 50,0% Type of practice 40,0% 30,0% 20,0% 10,0% 0,0% Academic University Private practice Mixed ESSO Clinical Research Committee survey Is sup p o rt a va ila b le fo r multi-ce nte r clinica l re se a rch in yo ur institutio n/ho sp ita l? Answe r Op tio ns Yes No Pe rce nt Co unt 74.7% % 46 a nswe re d q ue stio n skip p e d q ue stio n

6 What are the obstacles in initiating or participating in a surgical trial? Please rank from 1 to 8 (1 being the most important obstacle) Others Lack of research facility/personnel to support research activity such as case report form completion Difficult to control surgical quality Difficult to do randomization Lack of interest (either due to personal reasons, career path, hospital policies) Lack of training in research methodology Lack of funding 0,00 1,00 2,00 3,00 4,00 5,00 6,00 Lack of time

7 Other reasons Research support Lack of specialized data entry Lack of cooperation of senior personnel No senior on same specialty Support and funding are great barriers. Difficult procedure for study start in lower Austria, work may only be performed within official working hours (48 per week per physician) lack of study nurse Lack of support from the institution Lack of relations with other institutions Lack of vision from hospital management (clinical production is considered much more important than (surgical) research) Patients Regulatory Relationship with Other disciplines Financial Scientific Informed consent by (medical) illiterate patients or other languages Lack of numbers in a small country with small recruitment for rare pathology Number of patients Volume of patients may be a problem Participants Some regulation relevant our legal system We are doing a clinical trial Risk to be sued Process of getting ethical approval too challenging Hospital has not own med ethic com and regulations and paperwork is rather time consuming/expensive and sometimes overregulated Ethical committee clearance for new or novel procedures Certain radiotherapists do not discuss the case during the multidisciplinary meeting at our institution before initiating radiotherapy but only during therapy, therefore excluding any possibility of proposing surgery. A therapeutic decision has often been made in an other institution without consulting any surgeon. Many smaller tumors are being irradiated but could have been operated if discussed. Communication with other part Lack of relationship between colleagues Difficulties in collaboration with other specialties Have to practice to earn a living, no financial returns from research Lack of important genuine points of research Scarcity of worthwhile trials Author policy of major journals. To be in the middle of the author list does not match the effort seriously participating in those trials.

8 ESSO Clinical Research Committee survey W o uld yo u b e inte re ste d in p a rticip a ting in a sho rt tra ining co urse o n surg ica l clinica l re se a rch me tho d o lo g y? Answe r Op tio ns Yes No Pe rce nt Co unt 74.7% % 45 a nswe re d q ue stio n skip p e d q ue stio n W o uld yo u co nsid e r this a s a n imp o rta nt a ctivity to initia te mo re surg ica l re se a rch? Answe r Op tio ns Yes No Pe rce nt Co unt 87.2% % 23 a nswe re d q ue stio n skip p e d q ue stio n W o uld yo u o r yo ur ho sp ita l b e willing to p a y fo r this? Answe r Op tio ns Yes No Pe rce nt Co unt 41.6% % 104 a nswe re d q ue stio n 178 skip p e d q ue stio n 17

9 Would you be willing to participate in a prospective surgical clinical research? Yes (non-randomized only) Yes (non-randomized and randomized controlled trials) No ESSO Clinical Research Committee survey W o uld yo u like to b e p a rt o f the ESSO/EORT C surg ica l ne two rk fo r clinica l re se a rch? Answe r Op tio ns Yes No Pe rce nt Co unt 93.5% % 11 a nswe re d q stio n 169 Click to skip edit p e d q uemaster stio n subtitle style 26

10 60,0% What is your main specialty? (several answers possible) 50,0% 40,0% 30,0% 20,0% 10,0% 0,0%

11 Surgery with translational research Which field/disease groups of surgical oncology would be the most interesting for you to do research on? Please rank the top 3 (1 is the highest) Others Sarcoma/GIST Peritoneal surgery Pancreas and Biliary Tract Lung Liver (primary/secondary) Head & Neck Genito-urinary Gynaecology Gastric Esophageal Colorectal Breast Brain 0,00 2,00 4,00 6,00 8,00 10,00 12,00 14,00

12 Please consider the below ideas for surgical research and rank them according to your interest (1 is the most interesting) Others Prospective registries Cost effectiveness / Health services studies Biomedical science trials / translational research / Basic research Pre-op and post-op management: prehabilitation programme Pre-op and post-op management: patient reported outcomes Pre-op and post-op management: QoL Pre-op and post-op management: ERAS and surgical nutrition Neoadjuvant and adjuvant therapy Comparison of surgical techniques or devices omparison of surgical techniques: standard versus extensive lymphadenectomy Comparison of surgical techniques: open versus laparoscopic 0,00 2,00 4,00 6,00 8,00 10,00 12,00

13 Others disease groups and research topics Melanoma skin Cancer Lung metastases Bone Metastased Endocrine Throid cancer Oncoplastic surgery Adjuvant surgery or not in pretreated patients Anatomy: fresh cadaver dissection Breast cancer related topics Conventional versus robotic surgery Emotional & psychological study for cancer pt. especially in gerontology age over 8th decade Enhancement of surgical skills Epidemiological research. Image guided surgery Impact reduction Molecular outcome prediction