Data Sharing Policy
Acta Medica Philippina requires Clinical Trials to be registered in a public database and that a data-sharing statement be provided. This policy will be effective upon its publication on the Journal's website
(https://actamedicaphilippina.upm.edu.ph/index.php/acta).
Clinical Trials are defined as studies that compare the effects of new tests, devices, treatments, and
interventions with another.1-4 It may involve patients, healthy people, or both. All Phases (1 to 4) of a
clinical trial are within the scope of this requirement. Clinical Trials involving human subjects residing in the Philippines must be compliant with the Philippine FDA Regulations on the Conduct of Clinical Trials for
Investigational Products.5 A clear statement from authors that their Clinical Trial is fully compliant with
such Regulations need to be included in the Methodology (or equivalent) part of the manuscript. The
The journal does not verify such statements but leaves this responsibility to the authors.
Clinical Trials need to be registered as per the laws of the country where such clinical trials are
conducted. The registry used for that purpose should be clearly stated in the Methodology (or
equivalent) part of the manuscript.6-8 In cases where such registration is not required in the country
where the clinical trial was conducted, a clear statement from the author(s) needs to be made and
included in the Methodology (or equivalent) part of the manuscript. Author(s) are likewise encouraged
to update the registration with the results as well as the full journal citation when the results are
published.
Acta Medica Philippina requires that a statement on data sharing is included in the manuscript reporting
clinical trial results in line with ICMJE recommendations.9 Data sharing statements must indicate the
following: whether individual deidentified participant data (including data dictionaries) will be shared
(“undecided” is not an acceptable answer); what data in particular will be shared; whether additional,
related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data
will become available and for how long; by what access criteria data will be shared (including with
whom, for what types of analyses, and by what mechanism). Some illustrative examples are provided on
the ICMJE website.9
References
1. National Health Service. Clinical Trials. https://www.nhs.uk/conditions/clinical-trials/
2. US FDA. Basics About Clinical Trials. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials
3. WHO. Clinical Trials. https://www.who.int/health-topics/clinical-trials#tab=tab_1
4. National Institute on Aging. US NIH. What are Clinical Trials and Studies? https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies
5. Office of the Secretary. Department of Health. Republic of the Philippines. Administrative Order
No. 2020-0010 Regulations on the Conduct of Clinical Trials for Investigational Products. https://www.fda.gov.ph/wp-content/uploads/2020/05/Administrative-Order-2020-0010.pdf
6. WHO. International Clinical Trials Registry Platform (ICTRP). https://www.who.int/clinical-trials-
registry-platform
7. US FDA. Clinical Trials. https://www.clinicaltrials.gov/search
8. Philippine Health Research Registry. Philippine Council for Health Research and Development. https://registry.healthresearch.ph/index.php/registry
9. International Committee of Medical Journal Editors. Clinical Trials. https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
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