By - Harsha Rajasimha, Ph.D. Founder and CEO Jeeva Informatics Solutions
The outbreak of the COVID-19 pandemic seriously disrupted new drug testing, treatments, and in-person healthcare services; access to clinical trial sites was reduced by some 80%.1 Emerging technology enables patients to interact with the clinical trial site staff remotely. This helps alleviate a traditional weakness of clinical trials-a lack of diversity among study groups.
In this Q&A Harsha Rajasimha, Ph.D., Founder and CEO of Jeeva Informatics Solutions talks about clinical trial challenges and solutions in a world still dealing with a pandemic.
What Have Been Some Existing Challenges with Traditional Clinical Trials?
The traditional brick-and-mortar clinical trial paradigm has long confined the access to patients living within a 50-mile radius of a clinical trial site. As a result, zip code becomes an implicit exclusion criterion. These locations are typically in the western countries in metropolitan cities resulting in a severe lack of diversity, equity, and access. Most clinical trial participants have historically been Caucasian, middle-aged males from affluent backgrounds. The traditional process is also very inefficient in terms of slow speed of operations and often breaks down at the patient enrollment stage. About 85% of all trials are delayed by a few weeks and about 30% of them terminate entirely due to poor enrollment. It’s no wonder that costs of operations have been scaling new heights over the last few decades. If any unavoidable changes must be implemented in a traditional clinical trial such as a protocol amendment or if in-person visitors are not possible at certain sites, the trial can come to a standstill or face unacceptable delays or miss data.
Apart from Reaching Patients Where They Are, What Are the Added Benefits of Decentralized Clinical Trials?
As a result of COVID-19, clinical trial operation teams are forced to reinvent themselves to ensure their continuity and integrity during the uncertainty of lockdowns and travel restrictions. The decentralized clinical trials paradigm that was showing early signs of adoption before the pandemic was accelerated significantly, freeing up clinical trials from the confines of the four walls of clinical trial sites. The benefits of decentralization in clinical trials are many. It can significantly improve the diversity, equity, and access for patients to find and enroll in trials. When implemented efficiently, decentralization can mean real-time data capture rather than monthly or quarterly verified data by traveling clinical research associates in-person. Choosing a bring your own device (BYOD) solution can further improve diversity and access from patients located anywhere with access to a browser-enabled mobile device and Internet access. A cloud-based Software as a Service (SaaS) solution can save significant time and costs of IT infrastructure and hardware. All these are bound to bring significant speed and cost efficiencies to clinical operations.
How Can an Organization Best Analyze Whether to Go with a Hybrid, Fully Decentralized, or Traditional Approach?
While there is no single right or wrong way to analyze this, we recommend asking the following questions during protocol design and trial planning stages early on:
- What primary and secondary points can be measured and captured remotely?
- Can patient screening and enrollment be completed remotely via questionnaires and telemedicine?
- Do local regulations and IRBs (institutional review boards) allow electronic signatures for informed consent?
- Can patient-reported outcomes and medication adherence be tracked remotely?
- Can sample collection be done by a visiting nurse or phlebotomist?
- Can patient follow-up visits for safety monitoring be performed remotely?
- Can expected adverse events be captured and annotated remotely as per Common Terminology Criteria for Adverse Events (CTCAE) guidelines adhering to local regulations?
- Are there accurate FDA-approved wearable sensors to accurately capture continuous streaming endpoints data from the patient’s body in-between visits?
By asking these questions, you can adjust the sliders for each trial activity between the site and patient home considering patient preference. This level of flexibility should not require the clinical operations team to employ multiple tools to validate and maintain. A single scalable software platform that can enable flexible clinical operations from a single login can save significant cost, time, and logistical burden on trial teams.
How Does Monitoring Work for a Decentralized and Virtual Clinical Trial?
There are several levels of monitoring that may need to happen in a clinical trial:
- Patient monitoring: An investigator monitoring patient safety. In a decentralized clinical trial, this can be done by telemedicine, videoconferencing, electronic surveys or questionnaires, and wearable device integration. Ability to communicate with patients in a bi-directional way by email, SMS, audio, video is crucial to ensure safe, secure, and continuous monitoring throughout the trial duration.
- Site monitoring: A clinical research associate monitoring the sites by visiting them regularly to check for patient recruitment timelines, verifying data quality, site compliance, and other site metrics.
- Medical monitor: Monitoring the clinical quality and safety aspects.
- Trial monitoring and reporting can all be performed remotely by a project manager from CRO or sponsor without requiring in-person visits. With a properly selected decentralized clinical trial platform, all the monitoring can be enabled remotely through dashboards and reporting the real-time status of the trial.
What are Some Areas in Medicine That Could Greatly Benefit from Further Studies Adopting Decentralized Trials?
Almost all disease areas are ripe for adoption, although the extent of decentralization may vary based on the specific study protocol. Chronic disease trials can benefit since the patients may have lifestyle conditions and the incentive for them to visit in person each time may be low. Whereas, in an oncology trial, patients may anyway have to visit the investigator site frequently to access therapies and disease monitoring. A small population gene therapy trial can benefit greatly as these are one and done treatments requiring long-term follow-up for assessing the safety and durability of these treatments. For rare diseases, this can be very useful in deep phenotyping of patients for maintaining patient registries, natural history studies, or remote informed consent for biorepositories. Observational real-world evidence studies or long-term cohort studies can be conducted in a fully decentralized manner with some or no in-person interaction at all.
References
- “No Place like Home? Stepping up the Decentralization of Clinical Trials.” McKinsey & Company, McKinsey & Company, 11 June 2021, mckinsey.com/industries/pharmaceuticals- and-medical-products/our-insights/noplace-like-home-stepping-up-the-decentralization- of-clinical-trials.
Dr. Rajasimha is the founder and CEO of the decentralized clinical trials software company, Jeeva Informatics Solutions,( www.jeevatrials.com) based in Virginia. He is a precision medicine data scientist-turned social entrepreneur on a mission to accelerate human-centric clinical research through technology innovation and global advocacy. He is the founder and chairman of the humanitarian non-profit Indo US Organization for Rare Diseases. Earlier, he served as co-founder and co-chair of the Organization for Rare Diseases in India from 2013 - 2019. He is academically affiliated as a faculty in the School of Systems Biology at George Mason University in Fairfax, VA since 2012.
Prior to founding Jeeva, Harsha was leading the healthcare and life science R&D practice at NTTDATA Services, a global top 7 consulting company. He was Vice President of business development at Strand Life Sciences where he led the commercial launch of next-generation sequencing-based genetic testing panels for rare diseases and Cancer. Earlier, he was a Sr. Director of Bioinformatics and Translational Research at Dovel Technologies, a Virginia-based health IT company, where he covered academic and US Federal Government contracts, advised FDA on the STARLIMS implementation program at their office of regulatory affairs.
Dr. Rajasimha has over a decade of experience working on various interdisciplinary projects involving genomics and big data as a consultant for clients including National Cancer Institute, National Eye Institute, Georgetown University, and Genome International Corporation. His research has focused on the genomics and systems biology of diseases including cancer, infectious diseases, neuromuscular diseases, and retinal degenerative diseases. He completed his M.S. in Computer Science and Ph.D. in Genetics, Bioinformatics and Computational Biology at Virginia Tech, where he developed and applied reusable simulation models of mitochondrial DNA heteroplasmy dynamics to study various diseases."
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