Choosing An EDC With A Robust API For Digital Therapeutics (DTx) Clinical Trials

Digital therapeutics (DTx) manufacturers may be surprised by how slowly clinical research moves compared with technology development. For example, pharmaceutical or medical device clinical trials can take ten or more years from conception to product commercialization.¹ The clinical world operates by different conventions and practices. Everything from planning to recruitment, to data collection and validation, to regulatory approval takes significant amounts of time.

In addition to the time clinical research requires, it doesn’t always include the connectivity DTx developers may expect. Not all digital research tools, such as electronic data capture (EDC) systems, automatically communicate with information sources or other software tools. Clinical research often includes slowly-moving, siloed components. For example, when a participant visits their local clinic for tests, clinic staff enter results into the participant’s EMR. Research staff may need to manually re-enter the data into the EDC for the clinical trial. Re-entry duplicates time and effort, which impacts trial efficiency.

Yet DTx developers need to enter the world of clinical research to establish their products. Not only are clinical trials often necessary for regulatory body approval or clearance, but they also help validate DTx in the eyes of the medical community, payers, and the public. Clinical trials also provide DTx developers with a wealth of data to improve and expand their products. Despite these benefits, app producers are not taking advantage of the opportunities available through clinical trials.