Multicenter trial

30
MULTICENTRIC TRIALS PRESENTED BY: Swati Sarin Jagmohan Hardipender

description

 

Transcript of Multicenter trial

Page 1: Multicenter trial

MULTICENTRIC TRIALS

PRESENTED BY:Swati SarinJagmohan

Hardipender

Page 2: Multicenter trial

CLINICAL TRIAL

“Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy.”

OR

“Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.”

Page 3: Multicenter trial

Introduction

A multicenter research trial is a clinical trial conducted at more than one medical center or clinic.

Page 4: Multicenter trial

Key Points In Muticentric studies

needs to assure standardization

uniformity of procedures

high data quality

collaboration across sites

Page 5: Multicenter trial

Distinction between multi-site studies and

multicenter studies

In both types of studies, multiple institutions perform the same procedures as others.

MULTICENTRE STUDIES

The investigators at the sites are involved as co-investigators in the planning of the study protocol and procedures.They scientifically responsible for the study results, and participate in manuscripts and other dissemination activities.

MULTI SITE STUDIES

The investigators at the sites do not participate as co-investigators of the study

They are merely carrying out the study (e.g. recruiting subjects, treating subjects, and/or following subjects) and thus can be viewed as contractors

Page 6: Multicenter trial

Coordination in Multi site studies

In a multi-site study, activities of protocol development ,development of study materials, training, communication, laboratory determinations, data processing and management, report generation, statistical analysis, and manuscript development are often centralized because of the need to standardize them across all sites, which often also has the further benefit of resulting in a gain of cost efficiency.

The central group ‘controls’ the data and hence the study; and must take steps to assure other participating institutions that it is managing it adequately.

This assurance is provided by developing adequate systems for staff training and quality assurance, collecting, entering, managing and analyzing the data. These activities are done by the statistical coordinating center

Page 7: Multicenter trial
Page 8: Multicenter trial
Page 9: Multicenter trial
Page 10: Multicenter trial

Advantages larger number of participants, Different geographic locations, The possibility of inclusion of a wider range of

population groups, The ability to compare results among centers,

All of which increase the generalizability of the study

In many cases, efficacy will vary significantly between population groups with different genetic, environmental, and ethnic or cultural backgrounds ("demographic" factors); normally only geographically dispersed trials can properly evaluate this.

Page 11: Multicenter trial

Enrollment of Subjects Enrollment should be competitive.

If the subject recruitment rate is lower than expected at one centre and higher than expected at another, planned allocation numbers should be transferred from the centre with low subject recruitment to a centre with high recruitment where subject inclusion is expected to be completed earlier than planned. This will be done to help ensure that subject enrollment is completed as planned.

Page 12: Multicenter trial

Set up Costs

The low set up costs should be negotiated in order to enable to sign agreements with larger number of sites

Page 13: Multicenter trial

Recruitment Rate Expected subject recruitment rate should be

evaluated.

Subject enrollment ends when the planned number of subjects is reached.

The recruitment rates estimate should be based on retrospective data provided by the investigator(s) from previous studies, i.e., on the number of subjects who would have satisfied the proposed inclusion/exclusion criteria in the past.

Page 14: Multicenter trial

Contd… The investigator(s) should make every effort to ensure

that the planned accrual rate is maintained

CRF’s are completed promptly and completely, and that data quality is maintained at all times.

The investigator(s) should discuss with the monitor any anticipated problems with recruitment or delays in study completion.

Number of sites for the study depends on estimated recruitment rates.

Page 15: Multicenter trial

Multicenter, Phase II Trial of Sunitinib in Previously Treated, Advanced Non–Small-Cell Lung

Cancer

Journal of Clinical Oncology, Vol 26, No 4 (February 1), 2008: pp. 650-656

Page 16: Multicenter trial

INTRODUCTION

Lung cancer remains the leading cause of cancer-related mortality worldwide, accounting for 1.18 million deaths per year.

Page 17: Multicenter trial

Contd… Non–small-cell lung cancer (NSCLC)

Vascular endothelial growth factor (VEGF) Platelet-derived growth factor (PDGF)

Growth factors that play an important role in tumor growth.

Page 18: Multicenter trial

Purpose

Aberrant vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) signaling

have been shown to play a role in non–small-cell lung cancer (NSCLC) pathogenesis and are

associated with decreased survival.

Page 19: Multicenter trial

Purpose ContD..

Evaluate the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multi targeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced NSCLC.

Page 20: Multicenter trial

Patients

Male and female patients 18 years of age or older had histologically proven stage IIIB or IV NSCLC which had progressed during or after treatment with at least one platinum-based combination chemotherapy regimen

Page 21: Multicenter trial

Study Design and Treatment

Phase II Open-label Multicenter study

Patients received sunitinib (50 mg/d) in 6-week cycles, comprising once-daily treatment for 4 consecutive weeks, followed by 2 weeks of no treatment

Treatment was otherwise administered for up to 54 weeks until disease progression or withdrawal of consent occurred

Page 22: Multicenter trial

Assessment

The primary end point was objective response rate (ORR)

Secondary end points included progression-free survival, overall survival, and safety

Page 23: Multicenter trial

End points Endpoint is the overall outcome that the protocol is

designed to evaluate.

PRIMARY ENDPOINTS These are the principal outcomes that the investigator is

looking for. Cure Sometimes difficult to reach

SECONDARY ENDPOINTS Evaluated when a significant number of trial subjects

fail to reach the primary end point , secondary end points help analyze the trial data

Page 24: Multicenter trial

Contd..

The primary end point of this study was the overall confirmed objective response rate (ORR),

defined as the percentage of patients with confirmed complete responses (CRs) or partial responses (PRs) based on radiologic tumor assessments (computed tomography, magnetic resonance imaging, and bone scans as appropriate)

Imaging scans included the chest, abdomen, and pelvis and were collected at the end of dosing in cycles 1 to 4, 6, and 8, and at study termination.

Page 25: Multicenter trial

Contd…

Other evaluations included medical history, physical examination (including height, weight, and vital sign measurements), laboratory tests (urinalysis, hematology, coagulation, and blood chemistry), cardiac function (12-lead ECGs), and adverse events (AEs)

Progression-free survival (PFS), duration of response (DR), overall survival (OS), and the 1-year survival rate were evaluated as secondary end points of the study.

Page 26: Multicenter trial

Results

 Of the 63 patients treated with sunitinib

Seven patients had confirmed partial responses, yielding an ORR of 11.1%

An additional 18 patients (28.6%) experienced stable disease of at least 8 weeks in duration.

Therapy was generally well tolerated.

Page 27: Multicenter trial

Conclusion 

Sunitinib has promising single-agent activity in patients with recurrent NSCLC, with an ORR similar

to that of currently approved agents and an acceptable safety profile.

Page 28: Multicenter trial

References Journal of Clinical Oncology, Vol 26, No 4

(February 1), 2008: pp. 650-656 © 2008 American Society of Clinical Oncology.

Shrikant I. Bangdiwala, PhD,(1) Cristiane S. de Paula, MS,(2) Laurie S. Ramiro, PhD,(3) Sergio R. Muñoz, PhD.(4); Coordination of international multicenter studies

Governance and administrative structure en.wikipedia.org/wiki/Multicenter_trial www.nih.gov/news/health/sep2008/nci-1

Page 29: Multicenter trial

Questions ??

Page 30: Multicenter trial

Thank You!!!