Under-reporting of harm in clinical trials

被引：82

作者：

Seruga, Bostjan ^{[1
,2
]}

Templeton, Arnoud J. ^{[3
]}

Badillo, Francisco Emilio Vera ^{[4
]}

Ocana, Alberto ^{[5
,6
]}

Amir, Eitan ^{[7
]}

Tannock, Ian F. ^{[7
]}

机构：

[1] Inst Oncol Ljubljana, Dept Med Oncol, Ljubljana 1000, Slovenia

[2] Univ Ljubljana, Ljubljana, Slovenia

[3] Kantonsspital, Dept Med Oncol, St Gallen, Switzerland

[4] Queens Univ, Dept Med Oncol, Kingston, ON, Canada

[5] Albacete Univ Hosp, Dept Med Oncol, Albacete, Spain

[6] Albacete Univ Hosp, Translat Res Unit, Albacete, Spain

[7] Univ Toronto, Div Med Oncol & Hematol, Princess Margaret Canc Ctr, Dept Med, Toronto, ON, Canada

来源：

LANCET ONCOLOGY | 2016年 / 17卷 / 05期

关键词：

RANDOMIZED CONTROLLED-TRIALS; ADVERSE DRUG-REACTIONS; COMMON TERMINOLOGY CRITERIA; RENAL-CELL CARCINOMA; QUALITY-OF-LIFE; PROSTATE-CANCER; ACCESS PROGRAM; LUNG-CANCER; PATIENT; OUTCOMES;

D O I：

10.1016/S1470-2045(16)00152-2

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Appropriate safety evaluations of anticancer drugs are crucial to assess their benefit-risk ratio. Substantial evidence shows that clinicians under-report harm in clinical trials, and at least three factors contribute to this problem: assessment of harm by clinicians might not represent the experience of patients; harm might be detected within trials, but is not reported appropriately by investigators or reporting is influenced by sponsors; and short-term follow-up might not detect long-term and potentially serious toxicities. Additionally, because of the selection of patients with good functional status in clinical trials, study results might not apply to patients treated in everyday clinical practice. New approaches for the conduct, oversight, and reporting of clinical trials should include patient-reported assessment of side-effects. Effective pharmacovigilance programmes and large-scale observational studies are needed to improve understanding of the tolerability of anticancer drugs in a real world setting.

引用

页码：E209 / E219

页数：11

共 74 条

[1] Physician-assessed and patient-reported outcome measures in chemotherapy-induced sensory peripheral neurotoxicity: two sides of the same coin [J].

Alberti, P. ;

Rossi, E. ;

Cornblath, D. R. ;

Merkies, I. S. J. ;

Postma, T. J. ;

Frigeni, B. ;

Bruna, J. ;

Velasco, R. ;

Argyriou, A. A. ;

Kalofonos, H. P. ;

Psimaras, D. ;

Ricard, D. ;

Pace, A. ;

Galie, E. ;

Briani, C. ;

Dalla Torre, C. ;

Faber, C. G. ;

Lalisang, R. I. ;

Boogerd, W. ;

Brandsma, D. ;

Koeppen, S. ;

Hense, J. ;

Storey, D. ;

Kerrigan, S. ;

Schenone, A. ;

Fabbri, S. ;

Valsecchi, M. G. ;

Cavaletti, G. .

ANNALS OF ONCOLOGY, 2014, 25 (01) :257-264

[2] Impact of Geographic Region on Benefit of Approved Anticancer Drugs Evaluated in International Phase III Clinical Trials [J].

AlHashem, H. Y. ;

Al-Mubarak, M. ;

Vera-Badillo, F. E. ;

Templeton, A. J. ;

Ocana, A. ;

Seruga, B. ;

Amir, E. .

CLINICAL ONCOLOGY, 2016, 28 (05) :283-291

[3] Oncogenic Targets, Magnitude of Benefit, and Market Pricing of Antineoplastic Drugs [J].

Amir, Eitan ;

Seruga, Bostjan ;

Martinez-Lopez, Joaquin ;

Kwong, Ryan ;

Pandiella, Atanasio ;

Tannock, Ian F. ;

Ocana, Alberto .

JOURNAL OF CLINICAL ONCOLOGY, 2011, 29 (18) :2543-2549

[4] Clinical experience with ipilimumab 3 mg/kg: real-world efficacy and safety data from an expanded access programme cohort [J].

Ascierto, Paolo A. ;

Simeone, Ester ;

Sileni, Vanna Chiarion ;

Pigozzo, Jacopo ;

Maio, Michele ;

Altomonte, Maresa ;

Del Vecchio, Michele ;

Di Guardo, Lorenza ;

Marchetti, Paolo ;

Ridolfi, Ruggero ;

Cognetti, Francesco ;

Testori, Alessandro ;

Bernengo, Maria Grazia ;

Guida, Michele ;

Marconcini, Riccardo ;

Mandala, Mario ;

Cimminiello, Carolina ;

Rinaldi, Gaetana ;

Aglietta, Massimo ;

Queirolo, Paola .

JOURNAL OF TRANSLATIONAL MEDICINE, 2014, 12

[5] Reliability of adverse symptom event reporting by clinicians [J].

Atkinson, Thomas M. ;

Li, Yuelin ;

Coffey, Charles W. ;

Sit, Laura ;

Shaw, Mary ;

Lavene, Dawn ;

Bennett, Antonia V. ;

Fruscione, Mike ;

Rogak, Lauren ;

Hay, Jennifer ;

Goenen, Mithat ;

Schrag, Deborah ;

Basch, Ethan .

QUALITY OF LIFE RESEARCH, 2012, 21 (07) :1159-1164

[6] Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study [J].

Basch, Ethan ;

Iasonos, Alexia ;

McDonough, Tiffani ;

Barz, Allison ;

Culkin, Ann ;

Kris, Mark G. ;

Scher, Howard I. ;

Schrag, Deborah .

LANCET ONCOLOGY, 2006, 7 (11) :903-909

[7] Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial [J].

Basch, Ethan ;

Deal, Allison M. ;

Kris, Mark G. ;

Scher, Howard I. ;

Hudis, Clifford A. ;

Sabbatini, Paul ;

Rogak, Lauren ;

Bennett, Antonia V. ;

Dueck, Amylou C. ;

Atkinson, Thomas M. ;

Chou, Joanne F. ;

Dulko, Dorothy ;

Sit, Laura ;

Barz, Allison ;

Novotny, Paul ;

Fruscione, Michael ;

Sloan, Jeff A. ;

Schrag, Deborah .

JOURNAL OF CLINICAL ONCOLOGY, 2016, 34 (06) :557-+

[8] Development of the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [J].

Basch, Ethan ;

Reeve, Bryce B. ;

Mitchell, Sandra A. ;

Clauser, Steven B. ;

Minasian, Lori M. ;

Dueck, Amylou C. ;

Mendoza, Tito R. ;

Hay, Jennifer ;

Atkinson, Thomas M. ;

Abernethy, Amy P. ;

Bruner, Deborah W. ;

Cleeland, Charles S. ;

Sloan, Jeff A. ;

Chilukuri, Ram ;

Baumgartner, Paul ;

Denicoff, Andrea ;

St Germain, Diane ;

O'Mara, Ann M. ;

Chen, Alice ;

Kelaghan, Joseph ;

Bennett, Antonia V. ;

Sit, Laura ;

Rogak, Lauren ;

Barz, Allison ;

Paul, Diane B. ;

Schrag, Deborah .

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2014, 106 (09)

[9] Systematic Collection of Patient-Reported Adverse Drug Reactions: A Path to Patient-Centred Pharmacovigilance [J].

Basch, Ethan .

DRUG SAFETY, 2013, 36 (04) :277-278

[10] Use of Patient-Reported Outcomes to Improve the Predictive Accuracy of Clinician-Reported Adverse Events [J].

Basch, Ethan ;

Bennett, Antonia ;

Pietanza, M. Catherine .

JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2011, 103 (24) :1808-1810

← 1 2 3 4 5 6 7 8 →