T-15: Natural History Studies: An Assessment of Current Trends in Design and Disease Research

Poster Presenter

Juliane Mills

Director Scientific Affairs, Real World Solutions
PRA Health Sciences
United States

Objectives

The primary objective of this research is to quantify and characterize the attributes (including duration, patient population, design, and funding type) of studies described as ‘natural history’ within a public dataset.

Method

Clinicaltrials.gov was searched for all studies entered through 08 Feb 2019 with ‘natural history’ as part of study title. All available characteristics of studies identified were downloaded and analyzed using Microsoft Excel. Study characteristics were then summarized.

Results

The clinicaltrials.gov dataset through 08 Feb 2019 contained 412 studies with ‘natural history’ within the study title. Of the 343 studies in the dataset with complete start and completion dates, the average duration (or planned duration) is 4.4 years (minimum of 0.7 years and maximum of 44 years). The funding characterization was complete for all studies in the dataset: 35% were designated as ‘other’, 32% were designated as funded solely by ‘NIH’, 11% were designated as funded solely by ‘Industry’. Three of the studies in the dataset did not include a start date. Of the remaining 409 studies, 51% had a recorded a start date during 2019. Less than 7% of the studies were limited to one gender of patient and less than 6% were limited to patients 17 years old or younger. As expected, a majority of studies (89%) were characterized as ‘observational’ study type.

Conclusion

Within the last 5 years, there has been significant growth in the number of studies registered within clinicatrials.gov as a ‘natural history’ study. The majority of these studies are not limited to a specific age or gender, which is similar to the dataset of all clinical trials registered within clinicaltrials.gov. Future research will explore if it is possible to illicit motivation for conducting the studies within the subset designated as funded by ‘Industry’ based other studies in process simultaneously within those companies.