Direction of Clinical Research and Innovation

The Oscar Lambret Center is a national reference center for clinical cancer research.

It is the only cancer center in France’s northernmost region Hauts-de-France.

To implement its research policy, in May 2016 the Direction of Clinical Research and Innovation was created, grouping together the existing components to implement and promote this clinical research activity: the Investigation Department with an integrated care unit (including the certified early phase center), Sponsorship Department (Methodology and Biostatistics Unit and Technical and Regulatory Project Management Unit) and Partnerships and Promotion Department.

Clinical research includes any study that aims to evaluate a new treatment/diagnostic tool or understand the causes or factors influencing the course of the disease. It provides new scientific knowledge necessary to make medical progress and improve care.

Although 80% of clinical trials are to evaluate new drugs, the Center is also very involved in trials investigating new radiotherapy and surgery techniques and trials evaluating quality of life (adapted physical activity, dietetics, humanities and social sciences, etc.).

 

The Investigation Department, a team working hard to give patients access to the latest innovations

This multidisciplinary department is responsible for patients enrolled in clinical trials at the Oscar Lambret Center.

With over 180 clinical trials each year, some 1,200 patients benefit from clinical research at the Center every year, which is above the Cancer Plan target of 10%. This shows just how involved and motivated the Center is when it comes to research and therapeutic innovation.

The trials conducted at the Oscar Lambret Center are sponsored by the pharmaceutical industry, cooperative and academic groups, but also include research with institutional sponsors. 

This Investigation Department has the capacity and motivation to conduct trials in all phases proposed by sponsors in France, Europe and elsewhere, including early phase trials through Lille’s CLIP²

Key figures

Over 180 clinical trials each year.

1,200 patients enrolled in 2020 at the Oscar Lambret Center

The Sponsorship Department, a team working for future patient care

An important part of developing clinical research at the Center is linked to dynamic sponsorship of clinical trials, proposed by the facility’s doctors or in collaboration with researchers from other establishments.

The studies carried out at the Oscar Lambret Center’s initiative are conducted in France or in Europe.  Each year, the center manages : 5 new studies, 20 studies being included, 35 active studies and 700 inclusions (except in 2020: 480 inclusions, COVID impact).

Our structure

Investigating physicians, clinical research associates (CRA), technical operators (radiotherapists, radiologists, pharmacists, biologists), dedicated nurses... an entire team of specialized professionals works together to meet the constraints and requirements of clinical research protocols and monitor patients closely. Clinical trials are indeed subject to rigorous monitoring and frequent reviews, necessary to assess treatment efficacy.

Clinical trial patients are treated by the integrated care team within the Clinical Research and Innovation Office Investigation Unit. Throughout the trial, they are closely monitored in a secure and regulated environment. The DCRI Investigation Unit holds the site authorization for the first administrations to humans and the clinical trials are conducted in specialized departments, in accordance with the highest international research standards.

The research teams are supported by specially trained staff and a specific structure with dedicated premises and beds.

There is a capacity of 10 day hospital beds, 1 treatment rooms with 2 armchairs and 4 consultation rooms for adult patients.

 

For children, the pediatric unit has 2 consultation rooms, 1 day hospital and 2 hospital rooms dedicated to research.  

The DCRI can also count on an efficient technical platform (MRI, CT, radiotherapy platform, pharmacy, tumor bank and cancer molecular biology platform).

The DCRI receives bachelor and master students each year, as well as medical and pharmacy interns and residents.

 

Our activities

  • Responding to requests from sponsors and clinicians
  • Planning and conducting clinical trials
  • Handling biological samples and images
  • Closing out clinical trials and archiving data

 

Our values

  • Anticipation
  • Organization
  • Responsiveness
  • Communication

 

Our team

Investigation team

 

Pauline SMIS - PAPILLON
CRA/CRT Manager
Secretary
+33 3 20 29 59 35
investigation@o-lambret.fr
8:30 a.m. to 5 p.m.

 

Sponsorship Team

 

Marie-Cécile LE DELEY
Sponsorship Unit Manager

Marie VANSEYMORTIER
Pharmacovigilance/Project Management Unit Manager
Secretary
+33 3 20 29 59 18
promotion@o-lambret.fr
8:30 a.m. to 5 p.m.

Marie-Cécile LE DELEY
Methodology and Biostatistics Unit Manager
Secretary
+33 3 20 29 58 93
umb@o-lambret.fr

 

Partnerships and promotion team

 

Marie Paule LEBITASY
External relations, promotion and quality officer

Aurélie THENOT-MARICOURT
Clinical Research and Innovation Office Quality Manager

Secretary
+33 3 20 29 59 81

Key figures

Over 180 clinical trials each year.

1,200 patients enrolled in 2020 at the Oscar Lambret Center

Sponsorship of clinical trials

Presentation

The Oscar Lambret Center’s sponsorship activities are handled by a multidisciplinary team:

  • Technical/regulatory and project management missions are handled by the Pharmacovigilance/Project Management Unit
  • methodology/biostatistics and data management missions are handled by the Methodology and Biostatistics Unit.

 

The Project Management Unit’s missions

This unit designs, implements and monitors clinical research projects coordinated by a clinician from the Oscar Lambret Center or another facility, and sponsored by the Center. It works closely with the Methodology and Biostatistics Unit and potentially the Caen Data Management Center to manage data and monitor the quality of such data.

It oversees the safety of patients enrolled in trials sponsored by the Center by autonomously monitoring the trials in accordance with regulations: registering, evaluating and reporting serious adverse events immediately (Suspected Unexpected Serious Adverse Reactions, SUSAR) or annually (Development Safety Update Reports, DSUR).

It also coordinates the organization of Data Safety Monitoring Boards (DSMB) to guarantee the benefit/risk balance of the trials sponsored.

This DCRI project management unit can also act as a national representative for foreign sponsors.

Download DCRI 2020 Activity Report

drci_2020_activity_report.pdf

The Methodology and Biostatistics Unit’s missions

The Methodology and Biostatistics Unit has four primary missions:

  • Providing methodology advice for all stages of Oscar Lambret Center’s clinical research, from design to promotion;
  • Managing some of the clinical databases for studies sponsored by the Center, to achieve databases ready for statistical analysis, and offering technical support to investigators to develop databases for the studies not sponsored;
  • Overseeing statistical analyses and helping to interpret them. Compiling end-of-study statistical reports and helping to prepare conference presentations and draft articles;
  • Contributing to the Center's teaching and research work, which includes designing and providing courses on biostatistics and clinical cancer research.

These tasks are in response to the increase in the Center’s research activities, both in terms of studies sponsored by the Center or coordinated by a doctor at the Center, and in terms of research projects specific to each department.

The Methodology and Biostatistics Unit works in close collaboration with the other DCRI units, in particular the Project Management/Pharmacovigilance Unit, the ITT (Invitation to Tender) coordinator and the scientific assistant.

Download DCRI 2020 Activity Report

drci_2020_activity_report.pdf

The Investigation Department’s missions

The DCRI Investigation Department is responsible for patients enrolled in clinical trials at the Oscar Lambret Center. It is a multidisciplinary department that includes an integrated care unit: the patients enrolled are taken care of in this dedicated unit, centralized within the Investigation Department. It is responsible for overseeing the logistical and regulatory aspects of all the trials conducted at the Oscar Lambret Center sponsored by the pharmaceutical industry, cooperative and academic groups and all research with institutional sponsors. It studies the trials’ feasibility and selects them together with the principal investigator and is in charge of all the logistic aspects of the clinical trials conducted: implementation, monitoring enrolment, patient follow-up, data collection and preparing audits and inspections and archiving. It relays with the sponsors’ operational staff.

The team guarantees the safety of the patients enrolled in these trials.

 

Understanding clinical research

patient_info.pdf
Download DCRI 2020 Activity Report

drci_2020_activity_report.pdf

CLIP²

The excellence of the clinical research at the Oscar Lambret Center was recognized in 2014 when it obtained the CLIP² certification (INCa-certified early phase center), which was renewed in 2019 (OLC coordination, Prof. Penel).

Of the 16 centers certified in France by the National Cancer Institute (INCa), the Lille early phase clinical trial center, Lille CLIP², supported by the Oscar Lambret Center and Lille Regional University Hospital under the aegis of the Regional Cancer Reference Center (C2RC), is one of the 7 sites to be recognized for its expertise in the care of both adult and pediatric patients.

The structured diagnostic expertise of the two facilities offers patients in the region optimal medical care and facilitates their access to suitable early phase trials. The Lille CLIP² thus reinforces the structures and resources dedicated to clinical cancer research. By increasing access to early phase trials, it gives more patients access to novel treatments.

At the Oscar Lambret Center, adult patient care is coordinated by Pr Nicolas Penel, while the pediatric CLIP is coordinated by Dr Anne-Sophie Defachelles.

 

An interregional patient referral network has been created to offer patients in the surrounding regions the greatest opportunity to access novel treatments (Lille and Normandy CLIP²) that extend to trials at the Curie Institute (Paris) and the Jules Bordet Institute (Brussels). Weekly meetings are therefore organized to discuss cases referred and already centralized.  

Contact

Pauline SMIS - PAPILLON
Early phase trials coordinator (OLC)
p-smis@o-lambret.fr
+33 3 20 29 58 54

Aurore ACROUTE
Lille CLIP² Project Manager (OLC-University Hospital)
aurore.acrouteditvampouille@chru-lille.fr
+33 6 12 09 13 83

Understanding clinical research

patient_info.pdf
Download DCRI 2020 Activity Report

drci_2020_activity_report.pdf

Coordinated by a mission manager, the DCRI enjoys different types of partnerships with clinical research experts, the industry (pharmaceutical firms and CRO), academics and institutions.

The goal is to be at the frontline of research development to help patients.

Close partnerships facilitate scientific and medical collaboration between the various links in the chain of therapeutic innovation.

The key objectives and values of the Clinical Research and Innovation Office are anticipation, communication, organization, responsiveness and quality of service.

We constantly monitor the quality of our services both from a technical and regulatory perspective and in terms of patient safety.

A quality manager coordinates the teams to drives our quality approach.

A scientific assistant assists the researchers at all stages of research promotion (from literature searches to the publication of articles). She is also the contact for organizing internal scientific meetings and scientific meetings with partners.

The DCRI's institutional and academic partners include:

«Au Centre Oscar Lambret, la prise en charge n’est pas que médicale. La relation de confiance reste la condition sine qua non pour mener à bien cette traversée.»
Sophie, patiente au Centre Oscar Lambret