Key Insights from Dr. Ayaaz Hussain Khan on “The Future of Clinical Trials: Challenges & Opportunities”

Our Global Head Generics, Dr. Ayaaz Hussain Khan, participated in a virtual roundtable on “The Future of Clinical Trials: Challenges & Opportunities”, along with Dr. Ravi Sekhar Kasibhatta, SVP & R&D Head, Lupin Pharmaceuticals, Sumit Garg, Global CIO, Piramal Pharma, Anirban Roy Chowdhury, Vice President - Clinical Research Pharmacovigilance, Bharat Serums & Vaccines Limited, Mukesh Kumar, Senior Vice President & Head, Clinical R&D, Cipla, and Mark Lambrecht, Director, EMEA & APAC Health & Life Sciences, SAS, on Tue, 26 Jul 2022.

The panelists were asked a set of questions to understand the future clinical trial trends and we have detailed below responses by Dr. Ayaaz Hussain Khan, Global head, Generics, Navitas Life Sciences. Some of these insights were shared during the virtual roundtable, along with inputs from the other panelists.

What challenges did you face and what were the opportunities that were created?

The entire industry witnessed widespread changes and challenges brought in by the pandemic. However, the unprecedented situation also allowed us to adopt remote and digital capabilities. The extraordinary times tested us immensely, and several changes were brought in, with digital advancements at the core of the changes.

Our primary focus was on protecting the health of our teams while ensuring that we maintained business continuity and there was no disruption to our ongoing work. The Navitas Life Sciences team worked remotely and leveraged our proprietary OneClinical^® analytics platform to understand the progress of trials remotely and in near real-time.

It helped immensely that Navitas Life Sciences has been supportive of members using innovative strategies to overcome challenges. It was amazing to watch how empowered teams stepped up to go above and beyond their responsibilities to ensure the continuity of projects, with a focus on patient safety and regulations.

The initial days of restrictions imposed due to the pandemic resulted in specific challenges in managing ongoing clinical studies, with patients unable to visit hospitals while it also disrupted the timely supply of Investigational Medicinal Products. Such logistic issues were handled fervently by the virtual team at Navitas Life Sciences, with intense collaborations carried out to find innovative ways of risk mitigation, resulting in minimal or no disruptions.

Some critical strategies adopted include online consultations, direct-to-patient shipment, home care visits to evaluate patient safety, and amendments to protocols. Patient safety and data integrity remained our biggest priority during the entire exercise.

AI and ML-powered platforms enabled study investigators to connect remotely and access data from clinical trials in near real-time. OneClinical^®, AI&ML-driven platform provided near real-time data during the trial for better control, proactive corrective action, and resolving critical issues at the onset. This will help in the intelligent deployment of resources.

Designed for and delivered via the cloud and in compliance with regulatory and data privacy requirements, OneClinical^® provides quality by design, effective oversight of trials, and actionable insights through comprehensive data visualization. OneClinical^® reduces source data verification through industry standards-driven central, remote and risk-based monitoring and enables data review, query reconciliation, and management through a configurable workflow-based solution.

Benefits of Using OneClinical^® Analytics

In a constantly evolving landscape, especially during the initial stages of the COVID-19 pandemic, there was an added need to have a pulse on relevant technologies and real-world insights to help with decision making, and our industry-leading networks provided just the right platform for that.

The unique perspectives and topics discussed in our networks have helped examine new ways of optimizing processes in the biopharma industry. They provide access to an independent community that delivers peer-to-peer interaction with regular opportunities to exchange insights, compare performance, and debate strategies to tackle the latest issues.

Do you think the COVID pandemic has brought in more acceptance of real-world data as compared to data from randomized clinical trials?

There was dependence on technology for data collection even before COVID-19, but the COVID-19 mediated disruptions catalyzed its adoption.

According to GlobalData, 67.3% of trial disruption during the COVID-19 pandemic in 2020 was due to suspension of patient enrollment, while 18.4% was due to delayed trial initiation. Slow patient enrollment had led to 14.4% of trial disruption.

The adoption of Decentralized Clinical Trials (DCTs) and the use of real-world data helped pave the way for patient-centric measures, enabling clinical trials to be conducted during the pandemic. Between 2014 and 2019, drug-based interventional DCTs exhibited a 7% CAGR while, between the latter half of 2019 and 2020, it grew to 77%.

DCTs leverage emerging technology and telemedicine to ensure better patient participation. Several advantages are provided by DCTs when compared with traditional methods.

What was the role of technology, especially digital and analytics, that helped in decentralized trials, remote monitoring, automation, and collaboration to perform effective clinical trials?

To harness the power of digital tools, it is important to understand the full benefits of their use in managing efficient clinical trials. Navitas Life Sciences has always invested in the right technology, moving with the dramatic raise in the importance of its use. When the COVID-19 pandemic began, our investement was made to quick use, making data driven decision making and virtual conduct of trials imperative.

Some of the benefits of virtual clinical trials are

Remote electronic monitoring: Research organizations have been looking for solutions to reduce cost and mitigate inefficient workflows as the complexity of clinical trials and demand for remote site connectivity continue to increase. COVID-19 has further emphasized the need for remote clinical trial monitoring solutions.

Patient retention: VCTs are patient-centered, meaning they are conducted from the patient's home with data transmitted using the patient's smartphone or a similar device. This increases the convenience for patients, especially the elderly and disabled.

Digital health data collection: There is a need to collect patient data post-study recruitment. Digital tools provide myriad ways of collecting patient data, like collecting previous medical health data, demographics, physiological parameters, patient activity, patient-reported outcomes, and images can be collected using smartphones or digital tablets.

Safety monitoring in virtual trials: There has been significant improvement in clinical trial efficiency due to the fast pace of digital technology adoption into routine processes, thereby lowering time and cost. In a bid to improve safety and validation, there are new tools that are now being paired with traditional biomarker assessments.

A vital advantage in safety monitoring using digital tools is continuous data collection for detecting infrequent events or for identifying events that may not occur during a study visit.

Data Security: Multiple technological advancements allow continuous patient monitoring. However, dependence on such digital tools leads to certain challenges that should be mitigated. The collection of patient data and subsequent transmission and analysis need to be performed with utmost security to prevent a data breach. The U.S. Food and Drug Administration (FDA) has provided guidelines like conveying information gathered using digital tools to all stakeholders. For example, Medical device certification aids in improving data security.

Data analytics: Comprehensive data analytics paves the way for extensible, flexible, and scalable clinical trials. The use of AI and ML in clinical trials aids in the seamless transmission of data, effectively connecting remotely.

Process automation using advanced and emerging technology help manage multiple facets of clinical trials.

Optimizing trial methods: There are multiple ways in which virtual resources support clinical trial optimization. A technique of intervention optimization, called micro-randomized trials, involves identifying factors like dose and timing that can be better managed using prompts or reminders. Such strategies to improve patient engagement enhance patient recruitment, enrolling, and retention. Personalizing the clinical trial process helps improve patient participation in clinical trials.

Limited Number of sites in VCTs: The Number of sites in VCTs is limited. For the same principal investigator, a team of multiple sub-investigators can ensure the health and safety of participants via remote visits where patients contribute with data virtually via their smartphones.

How effective are integrated cloud-based methods in protected clinical trials data sharing?

Certain risk factors need to be addressed while conducting virtual clinical trials, and partnering with a strategic and experienced partner will aid in using the right systems and checks to prevent a data breach. It requires good insight into regulations that govern the use of data in certain geographical regions and a pulse on the changing needs.

In a virtual clinical trial, since there is lowered dependency on physical sites, study participants may be enrolled from across multiple countries, with varying rules governing the conduct of the trial based on the regulatory authorities in the different geographical locations. Staying abreast with the latest in the field will ensure successful clinical research study outcomes.

Behavioral, anatomic, social, patient self-assessment, and other factors can now be obtained using digital technology, marking a paradigm shift in the dependency on digital monitoring. Activity trackers that are included in smartphones or sensors that can even detect cardiogenic chest wall vibrations for detecting heart failure or heart rhythm are examples of such digital measures. Other digital tools are glucose detection sensors that detect glucose levels from sweat or sensors placed in braces that are used during knee joint injury to identify structural health markers. Statistical analysis may be used on virtual patients with irregular heartbeats to identify the effect of blood thinners.

Digital technologies play a significant role in data collection, especially in instances where traditional methods have not been successful before, like in the use of apps on smartphones to identify certain disease conditions. For example, an app that is used to detect signs of Parkinson's disease requires patients to perform specified tasks.

There has been close monitoring of such technological advances to ensure data security. The use of the Apple watches to detect heart rhythm abnormalities, like atrial fibrillation, has been approved by the Food and Drug Administration (FDA) after rigorous checks. Therefore the use of integrated cloud-based methods will aid in providing vital information to enhance the efficiency of the trial.

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