information for researchers

 HIGH–QUALITY RESEARCH

PROVE Network performs high–quality research and initiates research projects based on ideas from researchers within and from outside the network; in every project an original hypothesis is tested, using an adequate study design and a sufficient number of patients

 PLAN OF ACTION

PROVE Network–initiated studies follow a strict action plan:

(1) each project is led by a Steering Committee that formulates the hypothesis and the primary and secondary endpoints, decides on the type of study to be performed, performs the power calculation, and drafts a study protocol;

(2) the Steering Committee submits the study protocol to an Institutional Review Board, usually the one in the hospital of the Principal Investigator of the new research project;

(3) the Steering Committee seeks for participating centers;

(4) communications are with the Principal Investigator; and

(5) the Steering Committee installs a Data Safety Monitoring Board that typically consists of at least four experts in the field, and one Statistician or Epidemiologist

TRANSPARANCY

each project is registered at www.clinicaltrials.gov, or a similar registry, to disclose exactly which hypothesis is going to be tested, what endpoints are used, and how many patients are needed; usually, the study protocol and analysis plan are also submitted to a peer–reviewed journal, like TRIALS; a running project can have a dedicated website, where important documentation can be found, and downloaded for use locally

PUBLICATION POLICIES

it is expected that every project will result in at least one scientific report on main findings of a study, following the original analysis plan; any analysis that was not reported in the original analysis plan will be reported as a posthoc analysis within that report; the first and usually the main report that comes from a PROVE Network–initiated project is written by the Writing Committee for that project, typically a subgroup of the Steering Committee; it is PROVE Network policy to submit the primary manuscript reporting on a randomized controlled trial or observational study with the intention to have it published as a paper by the PROVE Network investigators – this may mean that there are no names of individual researchers in the author’s byline; the Principal Investigator is mentioned as the contact person, the members of the Steering Committee, the Writing Committee, and ALL local investigators of participating centers are summarized at the end of a manuscript or in the appendix depending journal policy; if a journal does not accept this, another approach will be discussed within the Steering Committee, and an explanation and conclusion will be posted on the website of the project; notably, we follow the Guidelines of the International Committee of Medical Journal Editors regarding authorships

secondary manuscript reporting (i.e., a secondary analysis or analysis in a subgroup of patients) may follow another approach; for example, a secondary manuscript can be submitted by a group of investigators having their names in the authors’ byline, but always using 'on behalf of the PROVE Network investigators' or something similar

MERGING DATABASES

every study will result in a new set of data, and most of our studies will collect very similar data; by merging different datasets, a large powerful dataset can be obtained to test new hypotheses; every report that comes from a merged dataset must report its source; PROVE Network requires that the study groups producing the original databases are mentioned in any publication that might use their data; PROVE Network welcomes any publication that mentions all participating investigators at the end of a report, or in the appendix