Patient: From Participant to Partner in Clinical Research (Preprint)

UNSTRUCTURED Developing regions of the world face proportionally higher burden of various diseases but lack adequate infrastructure for conducting high quality clinical research. Lack of central mechanisms that ensure collection and collation of data generated at various sources often lead to incomplete source documentation for clinical research in low resource settings. However, irrespective of site of generation (various clinics, hospitals, laboratories etc.), the clinical data pertaining to one patient converges at that patient. Traditionally, patients’ role in clinical studies has been that of an informed participant. If we were to develop a model where the patient’s role is transformed from just being a participant to manager of her clinical data, we would be able to ensure completeness of source documentation for clinical research. For implementing this concept, we have developed mobile applications that are linked to clinical research databases and have interfaces for participant and study staff. Study participants can upload their clinical data as pictures, files, text etc. and use the mobile application as their digital repository. Data uploaded by participant becomes available in the indexed clinical database and can be used by the study staff to populate relevant data fields in study databases. This also aids data validation and verification in the context of clinical research. Though dependent on availability of internet and smartphones, this simple approach has potential to enhance the quality of clinical research in low resource settings.