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Preclinical animal efficacy studies and drug development

Preclinical animal efficacy studies and drug development. Most basic science journals do not evaluate studies solely based on their translational impact or drug development application

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Preclinical animal efficacy studies and drug development

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  1. Preclinical animal efficacy studies and drug development • Most basic science journals do not evaluate studies solely based on their translational impact or drug development application • Many studies would not even be considered ‘pre-clinical’. Rather, many studies just look at biological phenomena using animal models. • Poor reporting does not negate the biological result in many cases. • Not clear that quality of reporting is the major factor in lack of translation from published studies to drug discovery.

  2. Improving quality of published studies using animal models • Multiple issues could be at play here, including bad experimental design, over-arching conclusions, biased experimentation, inappropriate statistics, biased reporting etc • Most of these major issues are caught during peer-review. • Most journals do have statistical guidelines, as well as checklists of good experimental reporting, but there is no one set of standards that will fit *all* studies. • Limits to journals’ power: Journals rely on peer-referees to help spot errors and so it is difficult to enforce guidelines that do not have community buy-in.

  3. What do journals currently do? • All NPG journals have statistical and reporting guidelines that stress accurate reporting and design in their guide to authors. • Recommend that authors follow many of the guidelines outlined in ARRIVE. We do implement CONSORT guidelines for reports of clinical trials. • Referees are also asked to comment on adequate reporting and statistical practices. • Editors and copyeditors check for some common issues of reporting (n not defined, error bars not defined) when paper is accepted. • Authors are often unaware of good statistical practices (adequate sample size etc) and not all referees bring this up. • Very difficult to enforce reporting of ALL possible variables.

  4. Practically what can editors do? • Look out for common mistakes. • Train ourselves, authors and referees in better reporting and statistical standards. • We allow on-line methods up to 2000-3000 words and encourage authors to properly report. • Commit to running corrigenda if key methods details are not included in published paper

  5. Practically speaking • Education of editors, authors and referees on best statistical and reporting practices ongoing process. • We are committed to good reporting practices in our journals. • Good reporting guidelines adopted by virtually all journals have been shown to help improve reporting (eg, CONSORT) • Practically, essential to identify the key critical reporting details that would be of most value for further translational or drug-development study. • Need help from this community to reach a consensus on such reporting priorities • --Ex, statement on blinding.

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