About Pandora

Background

  • Difficulties in the development of independent clinical research.
  • Atomized or single-center research with a limited number of patients, representativeness, external validity, and clinical utility.
  • Convenience of increasing epidemiological analyzes and records.
  • Registration convenience.
  • Convenience of increasing analysis of real life data (RWD).
  • Suitability of translational research..
  • Advancing convenience in precision medicine.
  • Convenience of increasing the analysis of PROs (Patients Reported Outcomes).

Justification for its development

  • Provide a web tool that allows the agile and tailored development of databases adapted to specific research projects.
  • Facilitate the creation of the electronic data collection notebook (CRDe) of a cancer research project.

Aimed at independent researchers or established research groups.

It arises from the concern within the Section of Evaluation of Results and Clinical Practice of SEOM.

Objectives

  • Promote multicenter and representative research that increases its clinical usefulness in the field of medical oncology, attending to the need to increase knowledge of epidemiology, results in clinical practice, especially with a translational character for the sake of precision medicine and with coverage of clinical dilemmas in areas where evidence based on a clinical trial is not available.
  • Support the analysis and dissemination of results in the aforementioned areas.
  • Tool for projects with principal investigator (PI) partner of SEOM.
  • PANDORA – SEOM gives access to the tool so that the IP can design the CRDe adapted to each project.
  • PANDORA – SEOM gives access to the incorporation of data by the researchers involved via the web.
  • PANDORA – SEOM ensures the custody of the data.
  • PANDORA – SEOM allows access and download of raw data in a friendly format for subsequent statistical analysis.
  • PANDORA – SEOM currently does not provide statistical analysis of the data.

In order for projects to be considered for integration into the PANDORA tool, they must conform to a model template:

  • Qualification.
  • Background.
  • Justification.
  • Hypothesis.
  • Objectives.
  • Methodology:
    • Design.
    • Population.
    • Variables.
    • Statistic analysis.
    • Workplan.
    • Schedule.
  • Clinical utility.
  • Limitations.
  • Informed consent.
  • Category or type of study.
  • Reference CEIC evaluation (or commitment to obtain it in a maximum of 60 days after approval by the evaluation committee and before having access to the tool)
    • Options:
      • Yes, with attached document.
      • Pending, commitment to complete in 60 days.
      • No
  • Dissemination plan.
  • Research team:
    • Participating centers.
    • Researchers per center.
    • CVs.
  • Resources:
    • Material and human resources necessary for the development of the project.
    • Budget.
    • Financing.
  • Endorsements:
    • In the event that the participants are Faculty Specialists SEOM partners, it is not necessary.
    • In the event that the participants are Residents in Medical Oncology, SEOM partners, endorsement by the corresponding teaching Tutor.
  • Bibliography.
  • Option to attach other files and/or add a final comment or clarification.
For projects to be considered for integration into the PANDORA tool, you must request it through: Request study
  • SEOM statement of responsibilities.
  • Statement of responsibilities of the IP.
  • Only accessible to SEOM partner as IP of the project.
  • Certify the suitability of researchers – centers beyond the applicant:
    • The principal investigator has to give them access to the tool, confirming that they meet the requirements and taking responsibility for it.
    • The collaborating researcher, before being able to access the tool, must confirm through a section available on the PANDORA website that he complies with the commitment proposed by SEOM and is responsible for it.
  • Annual report mandatory by the IPs of each of the projects in progress.
  • Favorable evaluation of the annual report by the Evaluation Committee prior to the start
    • Evaluation by the Evaluation Committee.
    • Conformity assessment report, recommendations.
  • Final reportof results obligatory by the IPs of results of each project within the committed period.
  • Evaluation by the Evaluation Committee.
  • Conformity assessment report, recommendations.

The projects will be evaluated by an Evaluation Committee made up of 6 members:

  • Fixed representatives:
    • SEOM Section Representative Evaluation Results and Clinical Practice: Dr. Paula Jiménez Fonseca.
    • SEOM Board Representatives: Dr. Javier Gallego Plazas, Dr. José Angel Arranz.
    • PANDORA SEOM Developer: Dr. Alberto Carmona Bayonas.
  • Representatives to select for each project:
    • Specialists of the specific pathology, 1 or 2.
    • SEOM, in appropriate cases, will request the cooperative groups to submit a name to participate in the Evaluation Committee.
      • In the case of more than one group, they should be representatives of different groups.
  • Coordinator: Dr. Javier Gallego (Representante de la Junta SEOM y Representante de la Sección SEOM de Evaluación de Resultados y Práctica Clínica).
  • Time limit of membership of the Evaluation Committee, Coordination: 4 years.

Call for evaluation of projects for inclusion in the PANDORA registry:

  • Periodicity: All year open
    • Projects to approve: maximum of 5.
  • Resolution:The projects received will be evaluated on a quarterly basis.
  • Only one request per IP (SEOM partner) is admissible.
    • Principal Investigator implies being an interlocutor with SEOM, although several IPs may appear in your project.
    • The IP that already has a project in PANDORA will not be able to request a new one until the recruitment of the previous study has been completed.
    • Projects linked to a Cooperative Group, since they are not the objective of PANDORA-SEOM, will be considered, beyond the project itself, taking into account the capacity of the Cooperative Group compared to other applicants to develop the project outside of PANDORA-SEOM.
  • Statistical analysis and administrative tasks must be provided - managed by the researcher.

Standards for evaluation of a project

  • Confidentiality commitment.
  • Independent initial evaluation by each of the members of the Evaluation Committee.
  • Individualized report by each of the members within 15 days.
    • The report will consist of:
      • Decision: Rating from 1 to 5
        • Approved with comments: scale 4-5
        • Approved subject to minor changes: scale 3
        • Rejected with arguments: scale 1-2
        • Comments section: Comments are understood as the arguments for the decision.
    • Although the final evaluation is in accordance with the above, the tool will facilitate the dispersed evaluation of the project to facilitate the work of the evaluators.
  • Joint evaluation:
    • Term of 30 days.
    • In a joint meeting of evaluators (virtual).
    • Approved: requires at least 3 passes (50%). In the case of only 3 approved, one of them must be from the coordinator.
    • A report will be generated for the applicant through the PANDORA tool with decision and comments (minor changes, other comments, rejection arguments). It will not be sent until all the projects are evaluated and it will be done jointly when it has been determined by SEOM.
    • If approved with minor changes, the applicant will be given a period of 30 days to respond to this proposal and incorporate the suggested changes into the project.
      • If it does not comply with the stipulated, this project may be replaced by one of those that has been left in reserve.
    • In case of rejection, if the applicant wants to resubmit the project, they must argue the changes based on the arguments for rejection and incorporate the new project with the highlighted changes.
  • Final evaluation: It arises from the joint evaluation.
    • Project approved.
    • Approved conditional on minor changes.
    • In reserve approved. In the event that those approved with change do not comply.
    • Rejected with arguments.
    • The final evaluation will be released on the same day for all projects.
  • As a whole: 15 days for individual evaluators, 30 days for a joint one.

Criteria for evaluating projects

These are the criteria that the evaluators will consider in the individual evaluation and in sharing their evaluations.

  • Representativeness:
    • Multicenter.
    • Intercommunity.
    • National.
  • Number of patients.
  • Epidemiological variables.
  • Risk factor's.
  • Prospective vs retrospective vs ambispective.
  • RWD.
  • Precision medicine.
  • Translational character.
  • Multidisciplinary character.
  • Evaluation of health results.
  • Inclusion of PROs.
  • Project duration.
    • Time limit for access to the tool to incorporate data.
  • Consideration of simultaneity of similar projects in the same call.
  • History of the research team (consolidated, emerging), cooperative group, independent...
  • Originality of the objectives.
  • Applicability of the results.
  • Project feasibility.

Upon approval and notification by the Evaluation Committee, the IP must certify approval by CEIC of reference (unless it has been done in the initial presentation of the project) before the start of the project and within a period not exceeding 60 days.

If this is not the case, the authorization to use PANDORA will be withdrawn and its space will be assigned to the first project in the queue of favorably evaluated but awarded in that call.

In case of modifications of the project initially approved by the Evaluation Committee after its passage by CEIC:

  • Evaluation by the Evaluation Committee of its relevance with respect to the previously evaluated within 30 days.
  • If it is considered that it distorts what was initially approved, it could justify reconsideration by the Evaluation Committee.
  • Access to tutorials on the operation of the tool.
  • Possibility of interaction of the IP of the project with those responsible for PANDORA in relation to the generation of the database.
  • Protocol accessible in SEOM-PANDORA
    • Opportunity to offer the incorporation of other centers to the project by contacting the IP responsible for the project.
  • Consider the need for registration in Clinical Trials Trials and/or in the Spanish Registry of Observational Clinical Studies (REec).
  • Through an advertisement on the SEOM website.
  • Through SEOM Informa, SEOM magazine.
  • Virtual session or ideally at the SEOM congress to present the tool and evaluation process, announcing the first call for 2022.
  • Participants:
    • SEOM
    • PANDORA Developer Manager