Source: Patient Worthy
Challenges Unique to Cell and Gene Therapies (CGTx) Clinical Trials
Cell and gene therapies (CGTx) have emerged as a novel and advanced treatment modality with a one-and-done administration. Clinical trials for these CGTx demand patient-friendly trial designs that fit into their lifestyle with the least burden.
These studies tend to involve a much smaller patient populations compared to other trials involving small molecule drugs or biologics. This means, researchers will need to gather more frequent data points from a small number of patients including from caregivers and observers of the patients.
Most of these patients tend to have severe diseases such as rare genetic diseases or Cancer with serious symptoms due to the nature of the disease(s), requiring special needs, choice of communication channels such as video, audio, texting, email, and other special accommodations.
Ensuring long-term patient safety remains challenging for CGTx. The FDA requirement for 15 years of safety follow-up after treatment demands integrated clinical trial management infrastructure including remote patient engagement and patient-centric apps. Additionally, CGTx trials have a need to be more inclusive of non-English speakers and more decentralized due to sparse distribution of the target populations.
Given this set of complex requirements, researchers have relied on CROs selecting 20-30 different software tools and point solutions to make one clinical study successful. Net result is siloed data and fragmented infrastructure resulting in significant integration and interoperability needs leading to overall high costs.
Patient-Centric Solution to Modernize CGTx Clinical Research
There is good news! Jeeva anticipated the need for human-centric and inclusive clinical research software solutions early on and has developed and validated mature solutions for almost six years now.
Team Jeeva is pioneering patient-centric clinical research software and CRO solutions to lead the way for genetic disease research and CGTx clinical trials at an Enterprise scale, centralizing the management of all studies under a single-login and subscription-based service.
Founded by a rare dad and patient advocate, Jeeva took the perspective that the only way to address these challenges holistically is with a comprehensive unified solution rather than with piecemeal point solutions that do not integrate and automate the process end-to-end.
Team Jeeva deeply cared about addressing this industry challenge to make time and investments to thoughtfully develop a cost-effective and human-centric solution for patient registries, natural history studies, CGTx clinical trials, and long-term follow-up studies.
Today Jeeva delivers optimized solutions that combine software, experts, and standard processes collectively as a turnkey configurable solution including study specific patient engagement portals.
The company’s comprehensive clinical research solutions cover software or CRO solutions for protocol design, IRB submissions, site qualification and initiation, patient screening, referral, randomization or enrollment, clinical data management, clinical trial management, patient engagement, biostatistical analysis, and reporting or manuscript preparation for publications.
Optimizing all these processes under one-login makes it cost-effective for small population clinical trials or population scale registries or cohort studies.
Having validated the clinical research software solution for use in settings such as GCP, 21 CFR part 11, HIPAA, with academic medical centers, Children’s hospital, and biopharma sponsors, Jeeva is partnering with clinical-stage biopharmaceutical sponsors to accelerate the development of affordable CGTx as well as health economics outcomes research (HEOR) studies.
With the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act now in play, sponsors of clinical trials must submit a ‘diversity action plan’ outlining how they will achieve diverse participant enrollment. Jeeva’s inclusive clinical research solutions align with the recent FDA guidance to improve enrollment of participants from underrepresented populations in clinical trials.
Jeeva has pledged free software solutions for 10 N-of-1 clinical trials such as the recently conducted phase 1 trial, AAV gene therapy for hereditary spastic paraplegia type 50.
