CTTI’s interactive database was developed as a tool to identify, collect, and organize feasibility studies using mobile technologies to capture data in clinical research, intended to serve as a dynamic, up to date repository. With this database, CTTI intends to help alleviate future development of redundant studies and contribute to the design and implementation of high quality, efficient trials.

The information can be used by investigators in the field to make decisions regarding which technology would be most useful for their research, by sponsors to support trial design, and may also be useful to researchers, patient advocacy groups, technology manufacturers, regulatory bodies, and ethicists for a variety of purposes, as laid out in the “Who should use” tab.

This database was created by a multi-stakeholder project team convened by CTTI. Original content was derived from a systematic search of scientific literature indexed in PubMed and published between January 2014 and May 2018*. Additional content will be reviewed and added regularly.

Four easy steps to navigate the CTTI Feasibility Study Interactive Database

Step 1: Type the research topic in “search the database”

Step 2: Select “Filter.” Categories will appear including Year, Technology, Concept, Therapeutic Area, etc.

Step 3: A drop down menu will appear for each category. Select the topic for each category (Ex. Year: 2015, Category: Operational Feasibility, Concept: Behavior Monitoring, etc.)

Step 4: Select the columns that the user would like to display (Can only select up to 8 columns). A list of publications will appear separated by the selected columns.

Table 1: Systematic review inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
  1. Included at least one mobile technology meeting our definition for objective outcome (efficacy or safety) data capture.
  2. Feasibility studies in line with our definition; specifically, if they address one or more, of the following components:
    1. Performance of an outcome of interest against a comparator where the outcome of interest could be related to:
      1. Measurement performance of sensor and/or;
      2. Algorithm performance (clinical endpoints);
    2. Human factors considerations (acceptability, tolerability and usability);
    3. Participant adherence;
    4. Completeness of data.
  3. Were conducted in a stated therapeutic area.
  4. Were conducted in a defined participant population that either:
    1. Included participants from the target population or;
    2. Included participants that would be generalizable to the target population.
  5. Country of origin is reported to have 'high' or 'very high' human development by the United Nations Human Development Index.
  1. Used the mobile technology as a therapeutic intervention without capturing any outcomes data.
  2. Meta-analyses or review articles.
  3. Editorials/letters/opinion pieces.
  4. Computer simulations.
  5. Did not evaluate mobile technologies capturing objective outcomes data (note that ePROs as the primary technology were considered out of scope).
  6. Do not capture data outside of the inpatient or clinic setting.
  7. Case studies (note that n-of-1 studies were considered in scope).
  8. Methods papers.
  9. Did not define the specific technology used.