Recommendations for the critical reading of clinical trials on disease-modifying drugs for multiple sclerosis

In recent years there has been an increase in the number of disease-modifying drugs (DMDs) approved for multiple sclerosis (MS). The evidence of their safety and efficacy has been obtained through several phase III and IV clinical trials. Acquiring the skills for their appraisal is indispensable for clinicians to assess the most pertinent treatment for patients. The objective of this study is to provide guidance in the critical reading of these trials.

A three-round e-Delphi study was carried out. In the preparatory phase, a multidisciplinary expert panel was established. Panel members were selected based on their scientific credentials and experience, seeking to include people involved in MS diagnosis, treatment and research. A semi-open questionnaire was developed based on key generic and MS-specific methodological instruments identified through a scoping bibliographic search. The experts were required to identify essential aspects for critically appraising clinical trials on DMDs for MS.

The expert panel consisted of nine independent leading Spanish experts with long-standing experience with MS (five neurologists, a neuroradiologist, a pharmacologist, a research methodologist and an MS community representative). The e-Delphi study resulted in consensus recommendations intended to help readers in answering five major questions: "Is the study free of bias?"; "Are the included patients adequate?"; "Are the outcome measures appropriate?"; "Are the results relevant?"; and "Is the study transparent?".

This study proposes consensus recommendations intended to guide neurologists in the critical reading of phase III and IV clinical trials on DMDs for MS.