Breast Cancer Awareness Month: Insights from a technology led CRO for Efficient Oncology Clinical Trials

October is Breast Cancer Awareness Month and it is an annual effort to bring awareness about breast cancer. According to the World Health Organization, 2.3 million women were diagnosed with breast cancer in 2020, making it the most prevalent cancer globally. Breast cancer leads to more disability-adjusted life years (DALYs) among women than any other cancer. There is an important need to find effective treatment to aid in improving the quality of life of women with breast cancer.

In line with this year’s theme, Navitas Life Sciences continues to RISE to support women with breast cancer by managing efficient clinical trials to help reach effective drug products to the market sooner.

End-to-End Clinical Trial Support

Navitas Life Sciences have been providing CRO services in US and across the globe for over 30 years, with 550+ clinical trials across 20+ therapeutic areas including Oncology. Our trial expertise is augmented by our proprietary OneClinical^® Analytics , a platform that delivers trial oversight and key data insights.

We met with Dr. Gangaram A.C, MD, Senior Manager Medical Services, Navitas Life Sciences to gain more insights about our support for oncology clinical trials. This is the second part of a two part series, where we discussed with Dr. Gangaram about how Navitas Life Sciences is a preferred partner for oncology clinical trials.

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 16 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.

Dr Gangaram A.C, MD

Senior Manager Medical Services,

Navitas Life Sciences

What are your special expertise for oncology clinical trials?

Nearly every sub-specialty and disease area is covered by Navitas Life Sciences. We are currently researching immunoglobulins and targeted chemotherapy as the cutting edge inside specific tumour types.

Patient comfort is of the utmost importance from the moment patients are enrolled in trials that we perform here at Navitas Life Sciences. We start by thoroughly outlining the trial's specifics, such as its duration, the sort of medication being used, and how it is meant to operate, frequently in a language the patient feels most at ease speaking. Additionally, we make sure that the patient is closely followed at every stage of the clinical trial procedure, both at the trial site and through dedicated 24/7 helplines for any issues even when the patient is at home.

In any disease, but particularly so with cancer therapy, the patient's family and close loved ones are kept informed of the potential, expected side-effects from participating in the trial as well as how to recognise and seek prompt medical attention in times of crises.

Even when selecting the appropriate patients for the trial, we make sure that the inclusion criteria are rigorously followed and that a variety of physical, biochemical, and pathological tests are carried out in order to hand-pick the patients who are most appropriate for the current clinical research.

Thousands of pages of data from animal studies, bioequivalence studies, and any other pertinent prior data are combed through from a regulatory viewpoint before a trial even commences in order to identify potential adverse and major adverse events during treatment. Additionally, we regularly and thoroughly update our clients and regulatory authorities on the findings of our initial and ongoing monitoring of the patients participating in our research, and we make sure that all international standards are always adhered to in this regard. In addition to self-policing, we frequently undergo audits by outside organisations, that corroborate our diligence and guarantee our ongoing dedication to patient safety and comfort.

Additionally, we strengthened our computer systems to guard against data breaches and put in place intricate auditing procedures that let certain of our employees—particularly the teams in charge of medical writing and data collection—work from home. For study recruitment, we used the internet and social media, and we also developed a unique trust-based patient recruitment system that allowed for remote screening of possible candidates while coordinating with nearby hospitals for the same.

What are the complexities in conducting Phase I oncology clinical trials and how do you overcome them?

Early-stage clinical trials may be hampered by a variety of hurdles and may be related to patient recruitment and management, logistics, issues with endpoints and so on.

The difficulties begin right from patient recruitment due to patient-related misunderstandings and obstacles. Other challenges appear after conquering the basic one of informing a patient about the opportunity to take part in a study.

Some patients may first be apprehensive about receiving a medicine with a limited track record or a placebo. Others could forego early phase research due to worries about how their health might change or about potential negative outcomes. However, oncology drugs that advance to early-stage clinical trials have already undergone in vivo or other preclinical testing, putting patient safety first. Each patient must receive enough information about the benefits and risks of participating in an early phase clinical study.

Any clinical study, but particularly an early phase clinical experiment, may put participants under logistical strain. Particularly for oncologic patients, travelling to the clinical trial site, several visits, demanding schedules, unpleasant procedure scheduling, and overnight stays may feel like an additional strain.

Patients might not be aware Slow enrollmentf payment possibilities including travel costs, lunch expenses, or even compensation for their time. Therefore, we urge sponsors to include this in their budget planning for clinical trials and make sure that all of these components are addressed beforehand.

Slow enrollment in early phase cancer trials can have a number of possible causes. However, safety issues, design challenges, and stringent eligibility requirements are the most frequently reported barriers to Phase I research. In order to ensure that your trial's goals are met, you must take into account a number of variables when planning the study, such as deciding on the eligibility requirements, setting up an adequate dosage escalation schedule, and creating a safety management strategy.

Early phase studies might be greatly hampered by laborious administrative processes and manpower requirements (research nurses, supporting staff). To take part in an early phase study, a location needs to have enough personnel, tools, and facilities. Early-stage research usually uses numerous treatments that are not part of standard care (intensive pharmacokinetics sampling, multiple ECGs, vital signs monitoring, repeated imaging tests, etc.). Therefore, clinical trial staff must be competent and able to give the study's execution their undivided attention and time. If the site is overburdened with administrative responsibilities, recruiting may suffer. We have specialist staff at Navitas to help scientists with administrative tasks so they may focus on subject recruiting and medical care.

Any oncological drug has the goal of increasing the overall survival time or the quality of life for the patient. The major endpoint in many late-phase cancer clinical research, overall survival, is an easy measure to assess and comprehend. Not only in phase III research but also in phase II trials, progression-free survival frequently acts as a stand-in for effectiveness. Early-phase oncology clinical trials can combine biomarker-driven surrogate outcomes prospectively to evaluate the biological action and response to immune-oncological treatments.

What are precision oncology clinical trials?

Next-generation sequencing (NGS) is advancing cancer treatment to unprecedented heights as part of the precision medicine (PM) revolution. Now that it is possible to identify actionable targets in real time, data from numerous clinical trials based on recognised molecular alterations can be evaluated and may assist in answering the question of whether personalised treatment based on genomics results in better survival outcomes than unselected treatment. Clinical trials with targeted therapies have demonstrated efficacy in patient molecular subgroups. Molecular profiling is used in PM trials as one of the eligibility requirements for success. Another intriguing finding is that the immune system is capable of recognising the neo-antigens produced by the mutanome, suggesting a connection between genomics and immunotherapy. Therefore, genomic markers, PDL1 amplification (for PD-1/PD-L1 checkpoint drugs), and tumour mutational burden are some of the key markers indicating response to immunotherapy. If molecular profiling-guided therapy in PM-designed clinical trials is to become the gold standard for cancer treatment, a number of issues still need to be resolved.

What is the ground-breaking advantage of adaptive oncology clinical trials?

The problems that contemporary oncology medication development must overcome are considerably different from those of the past. Phase III clinical studies are getting bigger and costlier, yet the success rate is still too low. Adaptive trial designs can improve development by addressing drug safety and efficacy while demonstrating how and who should be administered medicine. An adaptive design alters the trial's course based on the accumulating data, allowing multiple questions to be answered simultaneously.

A single trial might, for instance, determine the ideal patient group, dose and regimen, and treatment combinations before seamlessly transitioning into a phase III confirmatory trial. Adaptive designs depend on data, including that from patients who haven't met the trial's main objective. Predictions of the primary endpoints are made possible by longitudinal models of biomarkers, which include tumor burden measured through imaging. Building an effective and reliable trial, especially employing longitudinal data, is made easier by adopting a Bayesian perspective. I-SPY2, an adaptive trial that evaluates medications from many businesses in the same trial—a phase II screening process—evinces a new drug development paradigm that exemplifies personalized medicine. This is a real step forward for cancer research and beyond!

On-Demand Webinar: Innovation and Optimization in Early Phase Oncology Studies: Opportunity for speed, success and savings

Listen to our On-demand webinar as our subject matter experts explores key themes regarding

• How applying innovative designs in early phase oncology trials can accelerate timelines and reduce costs
• How to focus development on the most promising agents at the right doses in the right indications for the right patients
• Simple strategies on Dose Escalation: A legacy of statistical innovation
• Expert insights on Novel endpoints to sail through dose expansion and proof of concept

Listen Now

Speakers

Dr. Atul Gupta

Vice President-Medical & Scientific Affairs,
Navitas Life Sciences

Venkatesan Balu

Associate Director,
Global Data Sciences,
Navitas Life Sciences

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