An Insight into Oncology Clinical Trials at Navitas Life Sciences

It was World Cancer Day on 4th February 2022, and our latest blog highlights our successful management of oncology clinical trials. The theme for this year is “Close the Care Gap”, Navitas Life Sciences has been supporting improved care for cancer by running efficient clinical trials.

According to a recent report, in 2028, the Oncology drugs market is expected to touch USD 286.67 Billion, with a 9.1% CAGR. With over 30 years of experience in conducting clinical trials, we understand your key challenges and have established systems to run a successful trial. Right from phase I to phase IV, we support your organization from start up to closure, and beyond, with our regulatory insights and quality approach. Our services are backed by technology & analytics that are developed specifically to meet the challenges you face daily, giving you the competitive edge.

IDMP

Nearly 25% of our clinical Trials are on Oncology/Haematology

We took the time to interview Dr. Gangaram A.C, Senior Manager- Medical Services, Navitas Life Sciences to gain an insight into oncology clinical trials conducted at Navitas Life Sciences.

Tell us about your professional background and your specific expertise in conducting oncology clinical trials.

I am a doctor and a clinical pharmacologist. After completing a medical education, I went on to follow my passion and specialize in pharmacology.

I have over 15 years of experience in initiating and conducting clinical trials in India, most of that being in oncology. The spurt in regulatory approvals of medicines for terminal illness along with India’s growing importance as a hub for clinical research have allowed us at Navitas Life Sciences to develop specific clinical, regulatory and medical expertise within oncology.

As part of the Navitas Life Sciences team, I have worked within several oncological verticals, from GI to Head and Neck tumours and bring all this expertise to the table along with our experienced teams, who enhance the journey for sponsors, taking the journey from formulation to approval.

As a committed physician-researcher, I am most proud about my work within oncology and the impact that our sponsor’s products have on patients’ lives.

Dr. Gangaram A.C,

Senior Manager- Medical Services,
Medical & Scientific Affairs,
Navitas Life Sciences

What are our capabilities in conducting oncology clinical trials? How can we support restart of oncology trials affected by COVID-19?

While many branches of medicine deal with debilitating diseases, none come close to the trauma that is cancer. It affects everyone around, not just the patients, but their families, friends and even us, as treating physicians. I see many different kinds of patients from many a social background and with many different philosophies in life, but what truly remains unchanged is the look of hope that I see in the eyes of the participants of our trials, their look of hope that the morning will come and that the night will be eventually over.

Navitas Life Sciences has an expert group of qualified and experienced professionals including clinical doctors, researchers and industry-certified project management personnel as well as the tools required, all of which come together seamlessly in fulfilling our sponsors’ needs, all tailor-made to suit the specific regulatory and end-of-life care requirements in target markets.

Once the trial begins, one of the most important aspects is monitoring for adverse effects and unexpected side effects. Each and every recording and result from the trial has to be properly documented and the data available for external agencies to view and audit as required.

As one would expect, the immense volumes of data and the diverse group of people involved make managing clinical trials quite difficult. I have had to keep abreast of the latest developments on the market as well as the regulatory environments, while simultaneously monitoring the activities of the team members, all while ensuring that all participants of the trials are well cared for and not put through any unnecessary risks. I have also had to constantly understand the needs of our clients and ensure that their investments are respected with regard to timelines and ultimately approval by the relevant health authorities.

IDMP What are the complexities faced in oncology clinical trials?

As I mentioned previously, an oncology clinical trial has many moving parts. On the one hand we have the human aspect of patients and the healthcare personnel who form the core of the study. On the other, we have the information collected and the personnel dealing with this information in order to collect, document, store and interpret it. In my mind, two of the most crucial factors that go into making a good clinical trial include competent, experienced personnel and effective technology.

Navitas Life Sciences has recruited some of the best competitive minds in the industry. India has fast become the leader in global professional education, with hundreds of pharmaceutical sciences and associated courses among the most sought after. An English-speaking, motivated and highly-educated population provides the macroeconomic fuel that a niche sector like clinical trials requires to bloom. Navitas Life Sciences is at the forefront of this segment; recruiting, training and growing the future leaders of pharma! We are proud to be associated with some of the leading minds in the industry today.

Technology is crucial at every step of the way. The care of the patient, like in any hospital setup involves the use of a wide variety of diagnostic and imaging equipment as well as life saving ones. As compared to a few decades back, the entire clinical trial landscape has been transformed by the advent of computers and advanced data management tools (not to mention of course, those advances in medical and associated technologies). It would be next to impossible to conduct a trial in today’s World with just pen and paper based records and filing systems!

What are some of the digital solutions or technological innovations that are a part of our oncology clinical trials?

Navitas Life Sciences continues to remain the trusted partner to countless international clients owing in a large part to its specialized IT core, “OneClinical®”, a unique, tailor made service solution that augments and speeds up the development cycle. The time and cost involved in getting a drug to the market is between 10-15 years and 1.5 to 2.0 billion USD, a staggering figure necessitating efficient monitoring for optimum proficiency.

Productive patient monitoring and effective clinical endpoint detection are some of the impediments to a successful trial. OneClinical® provides near real time data during the trial, which can be used to better control such challenges during your trial. The use of such intelligent analytics empowers you to take proactive corrective action, resolving critical issues at the onset. This will help in intelligent deployment of resources which can save your time and your money.

All our clinical trials are backed by OneClinical®, our AI&ML driven platform that offers you near real time data visibility and analytics in an outcomes-based engagement model. With OneClinical®, you can make informed decisions and take proactive action to maximize the success of your clinical trial. Our eClinical platform enables end to end clinical trial data management, data visualization, analytics, monitoring and submission services. Proven across a variety of global trials, the platform offers short setup time with low fixed costs and provides global accessibility with near real-time data analytics and visualizations. Designed for, and delivered via, 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.

OneClinical® Platform:

Data Capture / Acquisition

  • Site Friendly
  • Smart Links – creating a more efficient workflow for each user
  • Field level edit checks and edits, including cross–panel logic checks fire immediately on data entry
  • Simplified Randomization, Subject Enrollment and Drug Supply Management
  • Latest statistical methods, programming and validation procedures
  • Online investigator visit monitoring reports
  • Workflow e–Signature authority

Data Aggregation and Analytics

  • Source System & Data Format Agnostic
  • Machine & Deep learning algorithms
  • Document–oriented database
  • Robust Mapping Engine
  • Interactive visualization TransCelerate, MCC and custom RACT Plans
  • Adaptive Monitoring Capabilities
  • Definable Risks parameters
  • Actionable Insights
  • Integrated Subject Review
  • Cross Study oversight

Data Submission

  • Consistent and Predictable time/effort from Study Creation to Define XML
  • Facilitates Use and Re-Use of existing/previous Study and Project Metadata
  • Define XML can be ‘quickly’ generated for single datasets or multiple

IDMPHow soon can we get the first patient in for an oncology study, from the time of study approval?

At Navitas Life Sciences, we have a tried and tested system of feasibility assessment, made possible through our well-defined and constantly updated database of participating healthcare institutions and healthcare professionals. Working closely with the protocol and clinical development teams, we ensure that the most productive sites are chosen for the given execution timelines.

From the date of start of a project, the business development team liaises with clinical development and operations teams, to tease out the feasibility. From analyzing the study criteria to legacy information-based forecasting, internal teams then send out initial requests via email, in-person and over conference calls to further narrow down the exact sites, physicians and supporting services that are best suited for the studies’ criteria. At this stage each criterion is once again whetted for any possible clinical impact that COVID or other factor may pose to the chosen sites in terms of delivering patient loads. Finally, the requisite legal and regulatory frameworks are documented and drafted for consent and Non-Disclosure Agreements. The entire process may vary from 2 weeks to several months depending on the degree of scarcity of patient populations for the given sub-specialty and specific cancer.

What are some of the important oncology clinical trials and the types of therapy being trialed?

At Navitas Life Sciences, we deal with almost every sub-specialty and disease area. Most recently, we are exploring Targeted Chemotherapy and Immunoglobulins as the cutting edge within certain tumor types.

While many of the specific therapy details are confidential, I can reveal that we have a very strong capability specifically within CA cervix CA colon , NSCLC, renal cell carcinoma and ovarian cancer. With the large population size in India, our research partners are confident in evenly balanced demographic recruitment for our clinical trials, allowing for rare disease trials and rare cancers as well.

Our feasibility recruitment team is constantly on the lookout for newer tertiary care centers to further our reach across therapy areas and specialized cancers as well. Over the past few years, we have almost tripled our on-boarded institutions while also reducing lead time for feasibility reporting via established relationships with physician investigators on the ground. Most importantly, all our sites are selected based on careful consideration of adhering to ethics and maintaining patient comfort as their priority.

Overall, our oncological experience and market penetration in terms of center availability is among the best in India and possibly the World.

IDMPHow did you cope with COVID-19 mediated restrictions?

The COVID19 pandemic has been a uniquely difficult time for business continuity, not least for clinical trials. However, at Navitas Life Sciences, we were able to maintain an adequate level of functionality without compromising on ethical, regulatory and price considerations.

I was instrumental in conceptualizing and implementing a specialized IT system which would allow remote video-based monitoring of the trials that would allow regulatory agencies, clients and auditing firms to access and observe the trials live, as well as document these for future auditing. This system was robust enough for us to even run a remote audit for one of the Western regulatory agencies during the pandemic.

We also enhanced our computer systems to prevent data breaches and instituted complex auditing systems that would allow for a portion of our staff to work from home, especially the medical writing and data collation teams. We turned to internet and social media-based recruiting for study recruitment and also pioneered a new trust based patient recruitment system that allowed for remote screening of potential candidates, liaising with local hospitals for the same.

Overall, I am proud to say that although we had to almost double our time and commitment to projects, we faced almost no delay in any of our client nor regulatory goals during the pandemic restrictions.

What are the oncology clinical trial trends for 2022?

Here are some of the new areas that I think could be the emerging trends in 2022.

Artificial Intelligence is being used in several applications including research. AI can be used to determine if certain individuals who are not research participants may be exposed to risk. Another key aspect would be Decentralized Trials. GlobalData has stated that nearly 1,300 trials with a decentralized and/or virtual component is expected to start this year, 2022. This would constitute a 28% increase from 2021.

There will also be significant technological advances in 2022, with the use of e-consent and web-based questionnaires to aid in running decentralised or hybrid trials. Another key trend is the use of blockchain technology which serves to secure data by duplicating and distributing it across the entire network of computer systems.

Can you please provide us with feedback received/ any anecdote associated with our oncology clinical trials?

I can safely say that the most enjoyable part of my job is the smile on the face of a successfully treated patient. However especially in oncology, every new day is a fresh start and it is true that not all patients pull through and some of them have undaunting spirits and tremendous courage.

One participant whom we encountered on the inguinal CA study was Zafar (name changed). Zafar was a photographer and had been suddenly jolted by his unexpected diagnosis. He had a family of 6 and had been working since a young age. With little to no resources, and far into the disease, Zafar’s recruitment and subsequent treatment gave his family hope and many wonderful days with him. Sadly, he eventually passed on and since the study was end-of-life based, his contribution will, in some small way go towards treating another patient and helping another family.

I remember how, during the recruitment, Zafar was intent on clarifying points on the Informed Consent Form (ICF) and we were able to provide a translated version for him to read in his native language. Although small, such seemingly infinitesimal and incremental changes, all add up to a better recruitment and dosing process, eventually translating into better data for our sponsors and undoubtedly giving hope to many thousands of patients with cancer under study.

Case Study: Effective delivery of a Full Service Clinical Trial for a First-in-Human Phase 1 Dose Escalation Oncology Study

Read our case study to find how we worked seamlessly with a US based company to deliver efficient and effective full-service clinical trial support for a complex study.

They were seeking full service clinical trial support to include:

  • Clinical Trial Operations
  • Monitoring
  • Safety Management
  • Data Management

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