Establishing a knowledge trail from molecular experiments to clinical trials

N Biotechnol. 2011 Sep;28(5):464-80. doi: 10.1016/j.nbt.2011.03.016. Epub 2011 Apr 5.


During the development cycle of a new antibody therapy, the therapeutic agent will be tested on subsequently more biologically complex models. New experiments' designs are based upon data gathered from prior models. New researchers who inherit the data and researchers from groups with different cultures or expertise are often called upon to interpret these data. Experiments which are not recorded consistently or employ ambiguous terminology can make interpreting these results difficult. The researcher who had originally collected the data may not be at hand to correct any misunderstanding or offer clarification and data can be unknowingly misused. This introduces an element of risk into the therapy development process. We have developed a reporting guideline for recording therapy experiments. This guideline consists of a checklist of data to be recorded from antibody therapy experiments performed in molecular, cellular, animal and clinical model.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Animals
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / immunology
  • Antibodies, Monoclonal / therapeutic use*
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / immunology
  • Antineoplastic Agents / therapeutic use
  • Clinical Trials as Topic / methods*
  • Enzymes / metabolism*
  • Guidelines as Topic*
  • Humans
  • Neoplasms / drug therapy
  • Neoplasms / immunology
  • Neoplasms / pathology
  • Prodrugs / adverse effects
  • Prodrugs / metabolism
  • Prodrugs / therapeutic use*
  • Research Personnel


  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • Enzymes
  • Prodrugs