Clinical Research Associates Research Articles

Challenges and Training Needs for Clinical Research Associates—A Survey

The objective of this articls is to understand the perceptions of clinical research associates (CRAs) about the time and effort required for monitoring; their importance in protecting the rights, safety, and well-being of subjects and data integrity; and their expectations about training needs and approaches. To these ends, a survey was conducted among 192 professionals with monitoring experience. Among other findings, the results show that CRAs rated source data verification as the most time-consuming activity, co-monitoring visits are the most preferred approach to learn monitoring, and CRAs need more training to learn to interact with principal investigators. There is a gap between CRAs’ perception of the importance of monitoring activities and the time spent on them.

Accuracy of adverse event reporting on a phase III clinical trial for pediatric acute myeloid leukemia: A report from the Children’s Oncology Group.

10028 Background: Adverse events (AE) on Children’s Oncology Group (COG) trials are reported by clinical research associates (CRA) on case report forms using the Common Terminology Criteria (CTC). CTC has increased in complexity from initially 49 AEs to 789 currently. This complexity challenges CRAs to accurately identify AEs. This study sought to evaluate the accuracy of AE reporting on a COG clinical trial and to determine if Pediatric Health Information System (PHIS) billing or microbiology data can improve AE reporting. Methods: Two pediatric oncologists performed chart review to identify 12 Grade III-V AEs (Table) for patients enrolled on AAML0531 at 11 hospitals across the United States and establish a gold standard. The sensitivity and PPV for COG AEs and AEs based on PHIS billing or microbiology data were calculated comparing to the gold standard. Results: Chart abstraction was performed on 179 patients (661 courses). PHIS billing data were available on all patients and PHIS microbiology data were...

Time efficiency and feasibility of Lesion Dashboard workflow for computing RECIST (Response Evaluation Criteria in Solid Tumors) treatment response assessment.

e17675 Background: Lesion measurements in oncology research subjects are communicated in radiology reports and manually tabulated by clinical research associates (CRAs) in most clinical research ce...

An Illuminating Partnership

An Illuminating Partnership

<b>治験モニターの治験実施医療機関への訪問実態</b> <b>―治験効率化に向けた一考察―</b>

Clinical trial sponsors have been requested to improve the on-site visit activities of clinical research associates (CRA) in Japan, because their activities are less efficient compared with those in the European Union and the United States. Although the sponsors have taken various measures in attempts to improve on-site visit activities, it is unknown whether or not the measures are effective to improve current activities at trial sites in Japan. We therefore surveyed the on-site visit activities of CRA at the University of Tsukuba Hospital. The mean number of on-site visits made by CRA decreased from 14.4 to 10.0/year per clinical trial from 2006 to 2012. The change in number of on-site visits differed depending on the objective of visit: the number of visits for transfer of documents and meetings for explanation of clinical trial information tended to decrease, while the number of visits for source data verification (SDV) as well as delivery and return of investigational products tended to increase. Outsourcing the delivery of investigational products to general transportation companies was started from 2009 (constituting 44% of all deliveries in 2012), and the frequencies of delivery and return of investigational products had increased using interactive voice response system or interactive web response system. These findings suggest that improvement in SDV as well as delivery and return of investigational products may have improved the on-site visit activities of CRA.

Measuring sleep disturbances in patients with alcohol use disorders: a short questionnaire suitable for routine practice.

Sleep disturbance constitutes a major risk factor for drinking relapse after alcohol withdrawal and necessitates regular follow-up. We reported previously that the sum-score of the 4 sleep items of the Hamilton Anxiety and Depression Scales (the Short Sleep Index [SSI]) constitutes a valid and simple sleep measurement tool. The objective of this study was to evaluate the psychometric features of the SSI relative to the lengthier Pittsburgh Sleep Quality Index (PSQI), which is widely used for measuring sleep disturbance in patients with alcohol use disorders during and after alcohol withdrawal. In this French, multicenter, cross-sectional survey, alcoholic patients were recruited in 2 academic hospitals and 1 community treatment center. Demographic data, alcohol history, and current consumption of alcohol and other abused substances were documented. The SSI and the PSQI questionnaires were completed in face-to-face interviews by a trained clinical research associate. A total of 257 patients were studied (88 females), with a mean age of 49 years (range: 24-80 years). The prevalence of sleep disturbance as measured by the PSQI and the SSI was 73.5% and 74.3%, respectively. The correlation between the 2 indices was strong (r = 0.764; 95% CI: 0.709-0.811), with negative and positive predictive values for the SSI (score > 1) of 71.2% and 89%, respectively, and an area under the receiver operating characteristic curve of 0.91 (95% CI: 0.85-0.92). The discriminant and convergent validity of the SSI was found to be noninferior to the PSQI. Compared to the PSQI, the SSI represents a quick, quantifiable, and reliable method that could help clinicians assess and manage sleep disturbance in alcoholic patients.

An Interactive 3D Lymphoma’s Stage Calculator Assistant: A New Tool to Help Hematologists in Routine Practice

Introduction:The lymphomas stages are currently determined by Ann Arbor-Cotswolds classification that have been created during the “Committee On Hodgkin Disease Staging Classification”, in Ann Arbor (Michigan, USA) in 1971, and modified in Cotswolds (England) in 1988. The classification is used in routine hematology, by doctors and Clinical Research Associates (CRA), in order to estimate the lymphomas’ spread, stratify patients and select therapies. In spite of its user-friendliness, every clinician knows that certain scenario depends upon operators.Despite lots of progress, there is no computerized tool that could help to establish an easy disease staging. A French hematological network, HEMATOLIM, in association with the University Hospital of Limoges, developed an information technology (IT) tool to calculate lymphoma’s Ann Arbor stage thanks to 3D interactive model. The aim of this work is to make available online an easy to use calculator for mapping all the lymphoma localizations on a 3D interactive mannequin and then obtain quickly a standardized Ann Arbor’s staging.Methods:That project has been developed by a mechatronic engineer from the “Ecole Nationale Supérieure d’Ingénieur de Limoges, France” since April 2013. This software is a 3D interactive model interfacing with Ann Arbor stage’s calculator. We used anatomical 3D library files, which represent human body’s tissues and organs. This free sharing and use database has been created by a Japanese team (Database Center for Life Science Research Organization of Information and Systems Faculty of Engineering Bldg.12; The University Of Tokyo; 2-11-16 Yayoi, Bunkyo-ku, Tokyo). That base concerns only males and doesn’t include lymphatic system. We modified it and added in this database the simplified lymphatic system and created female body’s tissues and organs. An expert radiologist approved the resulted projections. To make easier the selection of pathological areas, different tools were created (sectional view tools, magnifying glass, dissection scissors, list selection modality, display of territory’s names÷). This tool is PC compatible and uses OpenGL (Open Graphics Library) 3D engine. It should be used with updated Windows software and accepts all OpenGL versions (See figures 1, 2 and 3).With this 1.0 software version, 20 patients with Hodgkin lymphoma (n = 8) and non-Hodgkin lymphomas (n = 12), managed in our institution between May and July 2014, were evaluated. The Ann Arbor stages determined by physicians during multi-disciplinary team sessions (MDT) were compared with the results of software calculated by a junior CRA.Results:The rate of agreement between the two methods is 81%. MDT staging and Ann Arbor calculator results were in disagreement in 1 patient (6%). Finally, 3D dynamics model was unable to determinate stages in 2 patients’ files because some parts of body are not yet included in the model. Kappa coefficient was estimated to 0.827 ± 0.163 (CI 95%: 0.508 – 1.000), meaning a very good agreement.Discussion:We have planned a thorough study to confirm these preliminary results with 80 patients for each stage, in total 320 patients, to obtain a sensitivity or specificity of 95% and 5% of precision. This software represents a consistent help for physicians, hematologists or not. Easy to use, intuitive and fast, it could be an Ann Arbor reference calculator. Improvements are planned for better completeness of the affected tissues. This device could help during MDT to have a standardized and rapid staging. Moreover, that software may be used in educational methods for medical students especially with sectional view tools. It should be very useful in clinical research units to assist in collecting lymphomas data. This software can also help to calculates main scores and prognostic indexes (IPI, FLIPI, IPS÷).Conclusion:Online and full versions of this 3D lymphoma’s stage calculator assistant will be developed by our network to standardize the staging of disease and to optimize treatment decisions. This software developed initially for lymphoma, can be adapted to the TNM classification of cancers. It should be developed with isotopists and radiologists colleagues to create a new tool, in order to deliver the disease stage automatically from CT-scan or PET/CT. [Display omitted] [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

임상연구코디네이터의 역할수행에 대한 연구자와 임상시험모니터요원의 인식비교

본 연구는 임상연구코디네이터와 함께 임상시험을 수행하는 연구자 및 임상시험모니터요원이 인식하는 임상연구코 디네이터의 역할수행 정도를 비교분석하기 위한 조사연구이다. 본 연구의 자료는 2011년 3월 7일부터 11월 30일까지 4개 병원의 연구자 39명과 임상시험모니터요원 68명을 대상으로 구조화된 설문지를 활용하여 수집하였고, 기술통계와 t-test를 이용하여 분석하였다. 연구자와 임상시험모니터요원 모두 임상시험에서의 임상연구코디네이터의 역할수행이 매우 중요하다 고 인식하고 있었고, 그 중에서도 대상자 관리 업무에의 역할 수행 비중이 가장 높다고 인식하고 있었다. 그러나 각 항목별 역할수행 정도에 관해 연구자 집단과 임상시험모니터요원 집단 간 인식 정도를 비교해 보면 차이가 나타났다. 따라서 임상연 구코디네이터의 역할수행에 대한 인력 간 인식 차이를 줄일 수 있는 보다 객관적인 임상연구코디네이터의 업무기술 및 지침 개발이 요구된다.

Cross-sectional Study on Occupational Stress of Clinical Research Associates in China

Background: There had been large amount of discussion and comments regarding the clinical research associate (CRA) work stress and quality of life in DXY, the primary website focusing on medicine and pharmaceutics in China. Quite a number of clinical research professionals described various examples and cases reflecting higher occupational stress of the Chinese CRAs. No relevant paper to date in the world have been formally published that assessing the CRA’s workload or occupational stress. The purpose of the study was to investigate the occupational stress of the CRAs in China. Methods: Chinese CRAs with more than 6 months monitoring experiences were enrolled into the study by convenient sampling. The number of participants from multinational CROs, local CROs, multinational pharmaceuticals and local pharmaceuticals were controlled to a ratio of approximately 4:3:2:1. A total of 200 CRAs were surveyed for work stressor, personal strain and coping resources by Occupational Stress Inventory Revised (OSI-R) Chinese edition during January to March 2013. Results: Among the 178 participants evaluable, about 71.3% were females. Their average age was 28.76 years (SD=3.97 years), ranging from 21 to 42 years. 87.1% of the participants had a Bachelor’s degree or above. Around 29.8% of the participants had medicine background, and 48.3% had pharmacy background. Role Ambiguity (RA) stressor was higher among the CRAs of age ≤ 25 years, while responsibility was higher among the CRAs of age ≥ 36 years age group. Vocational Strain (VS) was also higher among those of age ≤ 25 years. A trend of higher self-care resources was observed in elder CRAs and those of higher education levels. The CRAs from multinational CROs had highest coping resources. Conclusion: This study revealed that the CRAs in China had moderate work stressor, personal strain and coping resources. The occupational stresses were varying amongst Chinese CRAs of different gender, ages, education levels and company types. The CRAs at age of ≤ 25 years had higher occupational stress than other age groups. The CRA’s personal strain and its facets had their predicating factors, role insufficiency and role boundary were the main risk factors, while rational coping, recreation, social support and self-care were the protecting factors.

Facilitating accrual to cancer control and supportive care trials: the clinical research associate perspective.

BackgroundAccrual to Cancer Control and Supportive Care (CCL) studies can be challenging. Our objective was to identify facilitators and perceived barriers to successful Children’s Oncology Group (COG) CCL accrual from the clinical research associate (CRA) perspective.MethodsA survey was developed that focused on the following features from the institutional perspective: (1) Components of successful accrual; (2) Barriers to accrual; (3) Institutional changes that could enhance accrual; and (4) How COG could facilitate accrual. The survey was distributed to the lead CRA at each COG site with at least 2 CCL accruals within the previous year. The written responses were classified into themes and sub-themes.Results57 sites in the United States (n = 52) and Canada (n = 5) were contacted; 34 (60%) responded. The four major themes were: (1) Staff presence and dynamics; (2) Logistics including adequate numbers of eligible patients; (3) Interests and priorities; and (4) Resources. Suggestions for improvement began at the study design/conception stage, and included ongoing training/support and increased reimbursement or credit for successful CCL enrollment.ConclusionsThe comments resulted in suggestions to facilitate CCL trials in the future. Soliciting input from key team members in the clinical trials process is important to maximizing accrual rates.

A national survey on patients’ enrollment rate in oncology clinical trials: The French experience.

e17567 Background: The rate of patients enrolled in clinical trials (CT) is one of the main indicators of clinical research and care activity. The successive French Cancer Plans (2003-2007 and 2009-2013) aimed at quantifiable targets of patients to be enrolled in high-quality clinical trials. To help investigators achieving this objective, a substantial financial support for clinical research associates (CRA) recruitment was given to University Hospitals (UH), Comprehensive Cancer Centers (CCC) and public or private community hospitals (CH). In the meantime, significant public investment was allocated to competitively selected academic projects through the Clinical Research National Program. Methods: From 2006 to 2011, we carried out annual national surveys on clinical research activities in oncology in France. A questionnaire was sent to cancer care institutions. Number of CT open for enrolment, number of CT sponsored by the institution, number of patients enrolled and human resources (CRA) were collected. Academic and industry-sponsored trials were analyzed separately. Results: We showed that the number of patients enrolled in CT increased continuously over this period: from 21,500 in 2002 to 35,400 in 2011 (+47%). Based on these figures and assuming that there were 420,000 to 472,000 patients eligible for CT over this period, the enrolment rate for patients in CT is estimated to be 7.5 to 8.5% in 2011 versus 5.8 to 6.7% in 2003. Nearly 80% of all enrolled patients were recruited in academic CT; over 75% of patients in therapeutic trials. UH and CCC equally contributed for 80% of enrolment, CH for the residual 20%. At last, the number of CT increased by more than 35% over the same period, while the number of CRA was multiplied by 3 over the French territory. Conclusions: Our results show that public intervention for improving enrolment to cancer CT seems to be efficient. Other types of intervention are being considered, i.e., targeted on investigators, on patients, or on both. Future work should also consider the impact of CT enrolment on patients’ outcome.

Investigation of clinicians' satisfaction on clinical research associates

Objective To investigate the satisfaction of clinicians on clinical research associates (CRA)and its influencing factors,for the purpose of providing rationalized proposals on education of CRAs.Methods 141 clinicians were randomly sampled from tertiary hospital for questionnaire survey,using the 5-point Likert scale.The survey covers 4 levels,i.e.,the work attitude,professional knowledge and ability,communication skills,and project management capabilities,as well as 14 dimensions.Data processing and statistics were analyzed using SPSS 15.0 software.The attribute characteristics of the investigation subjects were analyzed using x2 of the contingency table,along with analysis of its correlation with the general satisfaction on CRAs.Results The mean values of the 12 indicators range 2.28 to 3.75,with low satisfaction in general.Among these indicators,satisfaction of the service attitude of the CRA,and of their familiarity with the pilot program and CRF completion axe the highest,respectively,74.04％and 61.70％.Satisfaction of the rest 10 indicators falls below 50.00％.The chisquare analysis showed no association between satisfaction and gender,education,job titles.The satisfaction is different(P＜0.05)between those trained and those not,while there exists a significant differences(P＜0.01)between those participating in different number of tests.Conclusion Clinicians have a low satisfaction on CRAs.It is recommended to strengthen the training,establish a CRA occupation certification system,and to strengthen the clinicians' emphasis and competency of clinical trials.These actions will normalize the industry of clinical trials and improve the level of clinical trials in China. Key words: Clinicians; Clinical research associate; Satisfaction

Perception on Working Conditions and Utilization of Clinical Research Coordinators among Investigators and Sponsors

Background: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. Methods: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and χ 2 test or t test. Results: Among investigators and sponsors, 56.1 % and 95.0 % perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5 % of investigators and 68.8 % of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4 % of investigators perceived lack of experienced CRCs and 84.8 % of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6 % of investigators and 58.0 % of sponsors. Conclusion: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs.

Cross-Linking Indications and Effective Timing

Director, Refractive Surgery Department Dunya Eye Hospital Istanbul, Turkey. Laser Focus-Centre for Eye Microsurgery, 1KBC Zvezdara, Belgrade, Serbia. 3 Clinical Research Associate Refractive Surgery Department Dunya Eye Hospital Istanbul, Turkey. Chairman, Department of Ophthalmology, University Hospitals of Geneva, Switzerland. The first clinical results of collagen cross-linking in keratoconus were reported by a research group from Dresden University in 2003. In this study, 23 eyes of 22 patients with keratoconus were included and only one eye of each patient was treated except one case that was treated bilaterally. The follow-up period was from 3 to 47 (23,2 ± 12,9) months. The BCVA improved in 65% of the patients by an average of 1.26 lines. The refractive correction improved by an average of 1.14D. In 70% of the patients, maximum K was flattened by an average of 2.01D. K value remained stable in 5 patients and in 1 patient an increase of 0.28D was present. In 22% of the fellow control eyes, however maximum K value increased by an average of 1.48D. The same research group later published their long-term results in 2008 on 153 eyes of 111 patients. The minimal follow-up time was 12 months and the maximum follow-up was 7,5 years.

The Study of Education and Qualification for the Maintenance of Clinical Research Associate (CRA) Professionalism

The Study of Education and Qualification for the Maintenance of Clinical Research Associate (CRA) Professionalism

Negotiation skills for clinical research professionals

Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors.

Promoting positive approaches to dementia care in nursing

Summary This article provides an overview of factors relevant to dementiacare today. The number of people experiencing dementia is increasing and dementia is at the forefront of health policy. The evidence base for person-centred approaches andinterventions in dementia is expanding and nurses are central to implementing these across care settings. This is an exciting and challenging time for dementia care and nursing has a majorrole in leading and developing these changes in practice. Thearticle discusses the importance of wellbeing and the MentalCapacity Act in assessing and caring for people with dementia.Psychosocial and pharmacological approaches to dementia careare described and the need to support carers of people withdementia is emphasised. Authors Juanita Hoe, senior clinical research associate, Research Departmentof Mental Health Sciences, University College London, London, andRachel Thompson, dementia project lead, nursing department, RCN,London. Email: j.hoe@ucl.ac.uk Keywords

Tolerability of 5 mg Solifenacin Once Daily Versus 5 mg Oxybutynin Immediate Release 3 Times Daily: Results of the VECTOR Trial

Although antimuscarinic treatment is indicated for overactive bladder, many patients discontinue it because of dry mouth. Of available antimuscarinics oxybutynin is associated with the highest dry mouth rate. We compared the safety and tolerability of 5 mg solifenacin vs 15 mg oxybutynin immediate release. At 12 Canadian centers a total of 132 patients with overactive bladder symptoms (greater than 1 urgency episode per 24 hours, and 8 or greater micturitions per 24 hours) were randomized to 5 mg solifenacin once daily or 5 mg oxybutynin 3 times daily for 8 weeks. The primary end point was the incidence and severity of dry mouth reported after direct questioning. Efficacy end points (3-day diary documented changes in urgency, frequency, incontinence, nocturia and voided volume), and changes on the Patient Perception of Bladder Condition scale and the Overactive Bladder Questionnaire were evaluated secondarily. Of patients on solifenacin vs oxybutynin immediate release 35% vs 83% reported dry mouth (p <0.0001). Of patients reporting dry mouth severity was graded moderate by 13% and 42% of those on solifenacin and oxybutynin immediate release, and severe by 13% and 28%, respectively (p = 0.001). Patients in each group showed improvements in efficacy end points, and Patient Perception of Bladder Condition scale and Overactive Bladder Questionnaire scores from baseline to treatment end. Significantly fewer patients on 5 mg solifenacin once daily reported dry mouth vs those receiving 5 mg oxybutynin immediate release 3 times daily. Significantly fewer patients on solifenacin reported moderate/severe dry mouth. Significantly fewer patients on solifenacin withdrew from study due to dry mouth and there were significantly fewer overall adverse events. Solifenacin and oxybutynin immediate release were efficacious in decreasing efficacy end points, and improved Patient Perception of Bladder Condition scale and Overactive Bladder Questionnaire results from baseline to treatment end.

Training needs of clinical research associates

Clinical research is a relatively new field in our country that has seen very rapid growth in the last few years. Availability of personnel appropriately trained to the specific requirements of the role they will perform in clinical research is critical for capacity expansion. Our study attempts to understand the specific areas of knowledge and skills that are important for the role of a clinical research associate. The survey was conducted among clinical research professionals from industry and academia who had more than five years of clinical research experience and held important decision making positions in clinical research (stakeholders). The survey questionnaire was designed as a matrix of various clinical research roles on the y-axis and six knowledge modules and eight skills on the x-axis. Respondents were asked to rate the importance of the knowledge /skills to the role of clinical research associates on a three point scale. In discussing results, a significant response was considered to be 50% or greater positive response from the total group. The significant findings were that general, ethics and clinical trial execution modules were rated as critical for the role of clinical research associate. Regulatory module was rated as important for the role. The other significant responses were that three of the sub-topics in the methodology module - framing a research proposal/protocol and experimental design, designing case report forms and EDCs and conducting PK studies - were rated as important and one sub topic in the data management and statistics module was rated as not important. All the skills except leadership skills were rated as critical for the role. The findings of our survey were in general on the lines of expectations of performance of the role. The general, ethics and clinical trial execution modules are critical knowledge areas for the role of a clinical research associate. No clear trends emerged for some of the other modules. Leadership skills were not rated as critical to the role. This kind of a survey gives a good direction when training curriculum has to be designed for specific roles in clinical research. However, there is a need to expand the sample size to fine-tune the knowledge and skills areas.

First evaluation of the French cancer clinical research projects funding program (PHRC)

6601 Background: Data on success and failure rates of clinical studies are cruelly missing, especially for public funded programs. The French Cancer Plan 2003–2007 has launched such program as a specific extension of the wider ‘Programme Hospitalier de Recherche Clinique‘ (PHRC). Grant applications are submitted yearly. Funding is competitively based, projects being selected by a national committee supported by independent experts. A substantial financial support for the recruitment of clinical research associates (CRA) was launched simultaneously.We performed a preliminary analysis of the projects’ outcome 5 years after their funding. Methods: We carried out a survey of the projects funded in 2003 and 2004. A questionnaire was sent to the principal investigator. Data on project status, number of patients recruited per project, reasons for delay or failure, and publication results were collected. Projects were classified as failure (not started or closed for lack of inclusions) or success (ongoing or completed). Results: Of 257 projects submitted, 85 (33%) were selected. Of them, 24 failed (28%). Higher failure rates were observed for breast (5/11, 45%), gastrointestinal tract (6/16, 38%), genitourinary tract (4/11, 36%), and immune or cell therapy (8/15, 53%) projects. In contrast, haematological malignancies projects showed a low failure rate (3/20, 15%) as well as studies associated with translational research (6/34, 18%) or led by cooperative groups. The main reason for trials delay or failure was recruitment difficulties, due to overestimation of recruitment potential or restrictive inclusion criteria. Very few (&lt; 5%) mentioned difficulty raised by the evolution of the scientific question or competing studies. No financial issue was reported. With 4-year of follow-up, 25% and 52% of projects have been respectively published in a peer-reviewed journal or presented at scientific meetings. Conclusions: In this first set of trials funded by the French Cancer Plan 2003–2007, more than a quarter failed despite apparent adequate funding. Main cause was a discrepancy between inclusion potential announced and real accrual. Application processes should evaluate more carefully this issue in order to improve the effectiveness of public health funding interventions in the future. No significant financial relationships to disclose.