Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

OBJECTIVE: To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy. DESIGN: Qualitative analysis. DATA SOURCES: ClinicalTrials.gov trial registry. MAIN OUTCOME MEASURES: Established goals and related practices of the trial reporting system were outlined, examples and key characteristics of MPRPs were reviewed, and specific challenges in registering and reporting summary results to databases designed for traditional clinical trial designs that rely on a model of one study per protocol were identified. RESULTS: A reporting approach is proposed that accommodates the complex study design of MPRPs and their results. This approach involves the use of separate registration records for each substudy within one MPRP protocol (with potential exceptions noted). CONCLUSIONS: How the proposed approach allows for clear, descriptive, structured information about each substudy's prespecified design and supports timely reporting of results after completion of each substudy is described and illustrated. Although the focus is on reporting to ClinicalTrials.gov, the approach supports broader application across trial registries and results databases. This paper is intended to stimulate further discussion of this approach among stakeholders, build awareness about the need to improve reporting of MPRPs, and encourage harmonization across trial registries globally.

Chronically recording with a multi-electrode array device in the auditory cortex of an awake ferret.

It is known that anesthesia depresses neural activity and inhibits cortico-cortical interactions and cortical output. Hence, it is important to record from awake animals in order to better understand the full dynamic range of neural responses. We have developed a preparation for chronic, multi-electrode physiological recording in the cortex of the awake ferret. This paper discusses several of the advantages and disadvantages of the technique as well as procedures used to overcome potential complications associated with chronic implants in the ferret. Our solutions are well suited to the special species requirements, yet are also easily generalizable to other species.