Place de la France dans la recherche clinique internationale : enquête 2010 du Leem France et recherche clinique internationale

Lassale, Catherine; Sibenaler, Claire; Béhier, Jehan-Michel; Pletan, Yannick; Courcier, Soizic

doi:10.2515/therapie/2011007

Cited by 5 publications

(2 citation statements)

References 4 publications

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“…It has also been suggested that more participation in oncology clinical trials could lead to improved survival in cancer patients [ 2 , 3 ]. Nevertheless, patient enrollment remains particularly low in oncology clinical trials (according to the National Cancer Institute, less than 5% of adults with incident cancer participate in clinical trials in the United States) [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

“…But there is also evidence that Health Information Systems and Information Technologies can improve the recruitment process. A review of recent literature shows that many studies examine, discuss, and/or deal with support systems for clinical trial recruitment [ 5 ]. These are mainly concerned with addressing individual barriers, and sometimes with the development of tools to ease usability of eligibility criteria.…”

Section: Introductionmentioning

confidence: 99%

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Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials

Campillo‐Gimenez

Buscail

Zékri

et al. 2015

Trials

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BackgroundThe performance of randomized controlled trials (RCTs) is often hindered by recruitment difficulties. This study aims to explore the pre-screening phase of four prostate cancer RCTs to identify the impact of a systematic pre-selection of eligible patients for RCT recruitment.MethodsThe pre-screening of four RCTs opened at the Comprehensive Cancer Center in Rennes was analyzed retrospectively (French Genitourinary Tumor Group (GETUG) 14, 15, 16, and 17). Data were extracted from electronic multidisciplinary cancer (MDC) reports and manually completed by physicians and medical secretaries. These data were the main source of information for clinicians to discuss treatment alternatives during MDC sessions. The pre-screening decisions made by the clinicians during these MDC meetings were compared with those made after a systematic review of the MDC reports by a clinical research assistant (CRA). Any inconsistencies in decisions between the CRA and the MDC physicians were corrected by the principal investigator (PI).ResultsThe pre-screening rate was 9.1% during the MDC meetings, while it was estimated to be 12.9% after the final review by the PI, and 29% after the systematic review by the CRA. The study showed that 77% and 67% of the MDC reports did not mention clinical and pathological Tumor, lymph node and metastasis classification of malignant tumors (TNM) staging, respectively, and that 35 of the CRA’s 47 proposals rejected by the PI concerned implicit information (not specified in the MDC reports). Only one patient was proposed by the PI, and none by the CRA.ConclusionsThese results confirm that pre-screening could be improved by a systematic review of the medical reports. They also highlight the fact that missing data in electronic MDC reports leads to over-enrollment of non-eligible patients, but not to over-exclusion of eligible patients. Thus, our study confirms the potential gain in using semi-automated pre-selection of MDC reports, in order to avoid missing out on patients eligible for RCTs.Trial registrationThe trials evaluated in this study were previously registered with clinicaltrials.gov (registration number: NCT00104741 on 3 March 2005; NCT00104715 on 3 March 2005; NCT00423475 on 16 January 2007; and NCT00667069 on 24 April 2008).

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials

Campillo‐Gimenez

Buscail

Zékri

et al. 2015

Trials

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Méthodologie et gestion des essais cliniques à petits effectifs pour les maladies rares

Micallef

2012

La Presse Médicale

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Pharmacology and drug development in rare diseases: the attractiveness and expertise of the French medical pharmacology

Micallef

Boutouyrie

Blin

2017

Fundamemntal Clinical Pharma

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Developing drugs for rare disease can be challenging due to specific rare disease characteristics. The French Medical Pharmacology is structured and positioned to play a major role in orphan drug research and development due to the required expertise concentrated into pharmacology departments, exclusively implemented within the French university hospitals, public hospitals that are linked to a medical school (and often a pharmacy school) with numerous INSERM or CNRS labelled research units. In addition, these structures allow a close collaboration between researchers, academic institutions and biotech start-up (most of them being spin-off of the academic structures). Also, within university hospitals are located the clinical investigation centres, linking to the F-CRIN network and also to Inserm and hospitals, that enable care staff and researchers to be associated and clinical research protocols to be carried out on site, in full respect with ethic and regulatory aspects. As a consequence, this intra and multidisciplinary expertise offers all resource to elaborate a tailored approach for orphan drug development, in new entities as well as in repositioning. For preclinical development: drug screening, candidate selection (taking into account PK, metabolism, variability and potential toxicity) and preclinical models (iPS, animal models) that could allow a better translation to human research. For clinical development, we will mention here dose determination, safety evaluation and Orphan Drug Designation and Protocol Assistance preparation and submission. For post marketing evaluation and surveys, the pharmacovigilance, addictovigilance and pharmacoepidemiology expertise, combined with access to large databases allow a better approach to orphan drug use and safety. As outlined through two success stories (Charcot Marie Tooth, vascular Ehlers-Danlos syndrome), the added value of French Medical Pharmacology structures and expertise has been evidenced in the know-how, multidimensional and multidisciplinary approaches, allowing the development of numerous drugs that have been granted with Orphan Drug Designation and later Market Approval. Even if specific and possibly even more, the field of orphan drugs requires the respect of highest standards of safety and quality. French Medical Pharmacology intends to continue on this way and constantly improve his involvement in this field, committed to a single objective: answer the unmet medical need of patients with rare diseases.

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Place de la France dans la recherche clinique internationale : enquête 2010 du Leem France et recherche clinique internationale

Cited by 5 publications

References 4 publications

Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials

Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials

Méthodologie et gestion des essais cliniques à petits effectifs pour les maladies rares

Pharmacology and drug development in rare diseases: the attractiveness and expertise of the French medical pharmacology

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