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E UROPEAN S OCIETY O F S URGICAL O NCOLOGY Clinical Research Committee Survey on Challenges of Conducting Surgical Trials Results

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Page 1: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

Clinical Research Committee

Survey on Challenges of

Conducting Surgical Trials

Results

Page 2: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

Click to edit Master subtitle style

SURVEY RESULTS

Survey population = 3500

Total responses as of 24 August 2015 = 195

Response rate = 5.6%

Re sp o nse

Pe rce nt

Re sp o nse

Co unt

82.5% 156

17.5% 33

189

6

ESSO Clinical Research Committee survey

sk ip p e d q ue stio n

Ge nd e r:

Answe r Op tio ns

Male

Female

a nswe re d q ue stio n

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E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

Click to edit Master subtitle style 0,0%

5,0%

10,0%

15,0%

20,0%

25,0%

Age range

25-30

31-35

36-40

41-45

46-50

51-55

56-60

61-65

66-70

over 70

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E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

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Participating countries in the survey

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

One response

each

Page 5: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

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0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

Academic University Privatepractice

Mixed

Type of practice

Re sp o nse

Pe rce nt

Re sp o nse

Co unt

74.7% 136

25.3% 46

182

13

ESSO Clinical Research Committee survey

sk ip p e d q ue stio n

Is sup p o rt a va ila b le fo r multi-ce nte r c linica l re se a rch in yo ur

ins titutio n/ho sp ita l?

Answe r Op tio ns

Yes

No

a nswe re d q ue stio n

Page 6: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

Click to edit Master subtitle style 0,00 1,00 2,00 3,00 4,00 5,00 6,00

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 time

Lack of funding

Page 7: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

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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 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

Regulatory 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

Relationship with

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.

Other disciplines Communication with other part

Lack of relationship between colleagues

Difficulties in collaboration with other specialties

Financial Have to practice to earn a living, no financial returns from research

Scientific 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.

Page 8: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

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Re sp o nse

Pe rce nt

Re sp o nse

Co unt

74.7% 133

25.3% 45

178

17

ESSO Clinical Research Committee survey

sk ip p e d q ue stio n

Wo uld yo u b e inte re ste d in p a rtic ip a ting in a sho rt tra ining co urse o n

surg ica l c linica l re se a rch me tho d o lo g y?

Answe r Op tio ns

Yes

No

a nswe re d q ue stio n

Response

Pe rcent

Response

Count

41.6% 74

58.4% 104

178

17skipped question

Would you o r your hosp ita l b e will ing to p a y fo r this?

Answer Op tions

Yes

No

a nswered question

Response

Pe rcent

Response

Count

87.2% 157

12.8% 23

180

15skipped question

Would you conside r this as a n imp orta nt a ctiv ity to initia te more surg ica l

resea rch?

Answer Op tions

Yes

No

a nswered question

Page 9: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

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Would you be willing to participate in a prospective surgical clinical research?

Yes (non-randomized only)

Yes (non-randomized andrandomized controlled trials)

No

Re sp o nse

Pe rce nt

Re sp o nse

Co unt

93.5% 158

6.5% 11

169

26

ESSO Clinical Research Committee survey

sk ip p e d q ue stio n

Wo uld yo u like to b e p a rt o f the ESSO/EORT C surg ica l ne two rk fo r c linica l

re se a rch?

Answe r Op tio ns

Yes

No

a nswe re d q ue stio n

Page 10: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

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0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

60,0%

What is your main specialty?

(several answers possible)

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E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

Click to edit Master subtitle style 0,00 2,00 4,00 6,00 8,00 10,00 12,00 14,00

Brain

Breast

Colorectal

Esophageal

Gastric

Gynaecology

Genito-urinary

Head & Neck

Liver (primary/secondary)

Lung

Pancreas and Biliary Tract

Peritoneal surgery

Sarcoma/GIST

Surgery with translational research

Others

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)

Page 12: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

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Comparison of surgical techniques: open versus laparoscopic

Comparison of surgical techniques: standard versus extensive lymphadenectomy

Comparison of surgical techniques or devices

Neoadjuvant and adjuvant therapy

Pre-op and post-op management: ERAS and surgical nutrition

Pre-op and post-op management: QoL

Pre-op and post-op management: patient reported outcomes

Pre-op and post-op management: prehabilitation programme

Biomedical science trials / translational research / Basic research

Cost effectiveness / Health services studies

Prospective registries

Others

0,00 2,00 4,00 6,00 8,00 10,00 12,00

Please consider the below ideas for surgical research

and rank them according to your interest

(1 is the most interesting)

Page 13: E U RO P E AN SO CIE T Y O F U RG ICAL ON CO LO G Y ... · PDF fileTotal responses as of 24 August 2015 = 195 Response rate ... EU RO P E AN SO CIE T Y O F SU RG ... Cost effectiveness

E U R O P E A N S O C I E T Y O F S U R G I C A L O N C O L O G Y

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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