TECHNOLOGY & DATA MANAGEMENT
A successful, patient-centric decentralised solution
Rho guides clients through appropriate programme strategies, the challenges of unique clinical trials and helps drive development of marketing applications demanded by regulatory authorities.
A
mid-sized biotech company was in the middle of conducting an open-label long- term safety study, with 137 active patients
across 25 sites in the US and Canada. Then the Covid-19 pandemic hit. Facing clinical site closures and obstacles to patient availability, due to the pandemic, it turned to Rho for help. In response, Rho developed a customised and decentralised solution for the study that ensured patient safety and data quality, while allowing it to progress according to the FDA guidelines for conducting research during this pandemic.
A new approach First, Rho completed a data-driven risk assessment. The foundation to guide its decision- making process – the risk assessment – allowed it to identify and evaluate risks, and implement strategies to monitor those risks and make adjustments if needed – all while keeping a close oversight on identified triggers that warrant a change in its approach. Once the risk assessment was complete, hybrid, decentralised options for patient visits were created. If the clinical site remains open to see patients and the patient is able to come to the clinic, the visit is performed as it was pre-Covid-19. In the cases where the clinical site is closed or the patient is unable to travel to the clinic, Rho introduced and implemented all of the following ‘virtual’ or ‘decentralised’ patient options:
telemedicine visits
home healthcare visits local lab visits
direct-to-patient (DTP) investigational product (IP) shipments (from site to the patient) monitoring solutions
updated study documents and systems. 48 | Outsourcing in Clinical Trials Handbook
Virtual options Telemedicine visits, depending on site capabilities, are via phone calls or video conferencing. Conducted by the site staff with the patient to assess medication adherence and any new adverse events, the focus of telemedicine visits is to evaluate patient safety based on updated protocols, which outline the specific data necessary for collection and list any processes that should not be conducted remotely. One of these sites used a teleconferencing
platform for a video call, so the principal investigator (PI) could visually and audibly connect with the patient. The PI completed a brief physical exam worksheet as they asked the patient questions. Next, they asked the patient to perform physical self- checks and report on the health of their eyes, ears, nose and throat, as guided by specific questions. By arranging an in-person evaluation at a location and time that is convenient for the patient, a trained home healthcare medical professional can perform safety procedures, such as the collection of blood and vital signs. Some clinical sites might not immediately embrace home health solutions because of a perceived lack of control of the patient’s care, but Rho has had success by addressing these concerns with the sites and investigators early in the process to ensure buy-in and support. Some patients may opt to have blood draws
taken at a local laboratory close to their home. When possible, this opportunity reduces patient burden and keeps data integrity intact, since the local lab analyses the samples then sends those results directly to the sites. In these instances, sites are responsible for oversight of the local laboratories, informing them of which labs are needed and ensuring the results are received back from the local lab on time. For the dispensation of IPs, Rho’s courier partner delivers IPs directly to patients’ homes using a
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120
