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					                                                                          Active Ingredient vaccine                                                       Clinical
                                                                                                                                                     documentation


                        EARLY PHASE CLINICAL DEVELOPMENT PLAN


                                                                           “ Title”


       Product:




 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011
                                                                          Active Ingredient vaccine                                                        Clinical
                                                                                                                                                      documentation


                                                                                                                       TABLE OF CONTENTS


       Table of contents                                                                                                                          2
       1.           BACKGROUND AND RATIONALE                                                                                                      4
       2.           MEDICAL STRATEGY                                                                                                              5
       3.           OUTLINE OF MAIN PIVOTAL CLINICAL TRIALS §                                                                                     5
       4.           ANALYTIC DEVELOPMENT PLAN                                                                                                     6
       4.1.         Safety and reactogenicity                                                                                                     6
       4.3.         Immunogenicity                                                                                                                7
       .4.4.        Efficacy and effectiveness                                                                                                    8
       5.           CLINICAL DEVELOPMENT FLOW-CHART                                                                                               8
       6.           SUMMARY OF PIVOTAL STUDIES                                                                                                    8
       7.           LIST OF EXPERTS IN THE FIELD                                                                                                  8
       8.           BIBLIOGRAPHY                                                                                                                  8




 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011
                                                                          Active Ingredient vaccine                                                       Clinical
                                                                                                                                                     documentation



                                 GENERAL INFORMATION

       MISSION
       To be validated with Scientists and Investigators.

       Clearly state what are the intended claims of the product in terms of targets (age, countries, risk groups...),
       expected performances of the vaccine and the major criteria for a Go / No Go decision

       PRODUCT CHARACTERISTICS
       Antigens, adjuvants, route of administration




       EMVI PROJECT TEAM
                                                      Project team leader/coordinator:

       Medical                                                                       Production
       Principal                                                                     Production Project
       Investigator:                                                                 leader
       Monitor:                                                                      Inventor:
       Statistics/Epidemiol                                                          Pharmacotox
       ogy:                                                                          responsible:
       Principal Biological                                                          Stability studies
       Evaluator:                                                                    responsible:
       Data management:




 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011
                                                                          Active Ingredient vaccine                                                       Clinical
                                                                                                                                                     documentation


       1. BACKGROUND AND RATIONALE
                                                  (maximum 10 pages)
       Epidemiology and medical environment
            known and unknown
            which information is lacking?
            are epidemiological studies needed for the development of the vaccine?
                                    o     What is (are ) the correlate(s) of protection or immunity in target populations?
                                    o     Are certain immune responses correlated with better clinical outcome?
                                    o Are there genetic (haplotype) differences in populations that do better that others
                                          (immunologically and clinically)?
       Targets of the vaccine
            age, geographical zones, special risk groups, expected performance of the vaccine
       Status of competition
            Current vaccines and other products available (justification of this development)
       Scientific Rationale for vaccine development

                  Antigen choice
                  ( stage specific or multi stage, single or multiple antigens)
                  Stage specific----simple but lower chance of success ?
                  Multi stage---------complex but greater chance of success?
                  Do humans naturally respond to this antigen ?
                  What are the theoretical reasons why an immune response to this antigen would be detrimental to the parasite.
                  Are there in-vivo or in vitro tests that support this?
                  What would the investigators consider the best proof of concept test that they could design?

                  The choice of vector/formulation/antigen presentation system
                  Do we know what type of immune response we wish to induce?
                  Is an antigen delivery system known that achieves the required response?
                  Is this system validated (in animals? in man?) as a viable option for wide-spread use?

                  Potential advantages and limitations

                  Preclinical development
                  Correlates of protection/development of immunological tests for assessment of the quality of the immune response
                  Animal models

                  Route of administration
                  Is there any data to support alternative routes of administration of interest for the antigen (IM, SC, ID, oral etc
                  …)
       Summary of clinical development to date
           Results of previous studies.

 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011
                                                                          Active Ingredient vaccine                                                       Clinical
                                                                                                                                                     documentation

       Vaccine production
              How will the vaccine be produced ?
              (Recombinant protein/synthetic peptide/live vector/DNA vaccine)
              What expression system is required (prokaryotic,eukaryotic etc)
              Is an adjuvant required
              What reagents do we need to make to control our product and its immunogenicity
              What assays do we need to develop, qualify and/or validate before we initiate clinical trials
                            o Animal studies, including pharmacotoxicological studies
                            o Stability studies
                            o Quality control studies : are the test already developed and is there any product characteristics
                                 already available ?




       2. MEDICAL STRATEGY
       This important section should describe carefully the intended clinical development strategy which will result in a
       clear decision to proceed to development with a well defined product and with reasonable probability of success.
       Strategy for phase I/IIA
                 Define the rationale for the phase I-IIa studies. If there is a pivotal study which would form the basis of
                 a Go/No Go decision define the hypothesis, objectives, main outcome measurements, study design, time
                 lines and clinical costs
       Foreseen strategy for further clinical development
                 Underline the main critical steps of future development with a special emphasize to critical issues that may
                  make the development of special difficulty.
                  How do you plan to prove efficacy or to bridge to a surrogate marker.
                  Comment on sample size for efficacy trials , on possible study sites, on the need for more epidemiological
                  data

       3. OUTLINE OF MAIN PIVOTAL CLINICAL TRIALS §
           Trial          Phase              Site                        objectives                             #           Duration              Budget
             #                          (country)                                                         subjects          (months)              estimate




 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011
                                                                          Active Ingredient vaccine                                                       Clinical
                                                                                                                                                     documentation



       § as an example may include 2 or more of the following:
       1: consistency study
       2. interaction with other vaccine
       3. efficacy study
       4. large scale safety study
       5. safety and immunogenicity in special populations



       4. ANALYTIC DEVELOPMENT PLAN
       The analytical development plan must be completed for the phase I/IIA studies. As possible complete as
       much as can be projected for the rest of the phases to licensure. (Those studies, especially the efficacy
       study(ies), will be completed in detail for the Full Clinical Development Plan).

             4.1.             Safety and reactogenicity
             1.1.1       Safety

       (documentation on the incidence of rare, serious unexpected adverse reactions)
       Total number of adults ( > 15 years)

       Total number of children (2 to 15 years old)
       Total number of infants (0 to 2 years; can be more precise)


       Grand total




 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011
                                                                          Active Ingredient vaccine                                                       Clinical
                                                                                                                                                     documentation



             1.1.2       Reactogenicity .

       indicate in this table all studies that will contribute to the documentation of reactogenicity (systemic and local usual adverse
       reactions)
          Study #                Site                                          Objectives and Design                                              # subjects




       Total


             4.3.             Immunogenicity
             1.1.3        Justification of final formulation

       (This table should indicate phase I and II, dose response, and adjuvant studies that will contribute to the final formulation)
           Study                 Site                      Objectives and Design                         # subjects             Assay(s) to be used
               #




       Total


             1.1.4       Other clinical research studies

               specific immunogenicity studies (such as ADCI, CMI, ... etc) and other studies that will contribute to a
               Go/No Go decision
           Study                 Site             # subjects                                        objective and design
               #




 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011
                                                                          Active Ingredient vaccine                                                       Clinical
                                                                                                                                                     documentation


             .4.4.            Efficacy and effectiveness

       indicate here what information on efficacy might be obtained during early clinical research phases ( such as challenge studies or
       natural exposure
           Study #             Site                       Design                          #                                 End point
                                                                                     subjects




       5. CLINICAL DEVELOPMENT FLOW-CHART
       This flow diagram (decision tree) should indicate :
                  pivotal studies
                  Go / no Go decisions
                  links between studies
       It should cover all clinical development through licensure
       As many points may be still uncertain you can group several studies under a single heading (for example: studies dose
       ranging, schedule of immunization, interactions may be summarized under a single " phase II optimization studies" heading
       )

       6. SUMMARY OF PIVOTAL STUDIES
       Join here the summary of each pivotal study according to the enclosed model
       ( the number of lines for each topic is not limited: the summary should contain enough information to allow writting the full
       protocol)

       7. LIST OF EXPERTS IN THE FIELD
       For each expert please indicate:
       Name
       Institution
       Adress
       Field of expertise (such as epidemiology, case definition, immunogenicity, study design ...etc)

       8. BIBLIOGRAPHY


 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011
                                                                          Active Ingredient vaccine                                                       Clinical
                                                                                                                                                     documentation



       STUDY N°                                                SUMMARY                                        CLINICAL PHASE:
       Title of the trial


       Investigators and study site


       Planned Trial period (First patient in; Last patient out)

       Rationale


       Hypothesis


       Objectives



       Study design



       Short description



       Biostatistical methodology
       (sample size, statistical assumptions and methods, planned interim analysis, stopping rules)


       Inclusion and non-inclusion criteria


       Test and (if used) control product,                Nature, Dose, Route, schedule


       Evaluation criteria


       Anticipated results and potential problems


       Grant costs




 Information contained in this publication is the property of EURPEAN MALARIA VACCINE INITIATIVE (EMVI) and is confidential and will not be
disclosed to third parties without written authorization from EMVI.No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
                                or by any means -electronic, mechanical, recording or otherwise - without the prior authorization of EMVI.


E.M.V.I.                                                   97139b32-d410-40a5-89c8-a0fc1b5033f9.doc                                                           10/11/2011

				
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Description: clinical development plan