Journal of Developing Drugs
Open Access
ISSN: 2329-6631
ISSN: 2329-6631
Miguel Orri
InnovatOrri Pharma Consulting, Malaysia
Posters-Accepted Abstracts: J Develop Drugs
The conventional conduct of clinical trials can be inefficient, time consuming, very resource intensive and often inconvenient for trial subjects. Trial participation is often limited to people living in close proximity to study centers and multiple study visits can be inconvenient, leading to subjects dropping out from the study, slow recruitment and may compromise data quality. The session will describe a novel, innovative Participatory Patient-Centered (PPC) study concept in which an investigator interacts with participants directly, mainly via internet and telephone, and participants are not required to be physically present for clinical study site visits. Participants, who can be recruited without geographic limitations, undergo a newly designed remote electronic informed consent process and are followed up with eDiaries and web-based questionnaires. An investigator is available by phone or email at any time during the study. The PPC model can potentially benefit the patient, physician, and investigator in a number of ways. In order to demonstrate the flexibility of the PPC model, it can be used in combination with conventional trial elements and primary care physicians may be included in the management of engaged patients participating in the study. This concept can be applied to local and global clinical trials. The session will discuss the learning from the trial design, illustrate differences between the PPC model and conventional trials, demonstrate the benefits for patients, primary health care providers, investigators and regulators, highlight special considerations for implementation, and look at the necessary enabling changes in the trial environment to make this exciting new model most efficient.
Email: miguel@orri.co.uk