October is breast cancer awareness month, and Navitas Life Sciences continues to RISE consistently to the unique needs of oncology patients. Balancing technological advancements with a vital focus on patient requirements is an elusive sweet spot that Navitas Life Sciences has been able to master.
Navitas Life Sciences has supported over 550+ Clinical Trials, covering 120,000+ patients across 20+ therapeutic areas. In the thick of transformation, Navitas Life Sciences weaves together agile clinical trial solutions, allowing resources to be moved around flexibly in the ever-evolving eco system, but with a focus on patient centricity.
Navitas Life Sciences’ Oncology Experience
At Navitas, we understand the complexities of an oncology clinical trial and have vast experience and technical know-how, along with quick onboarding and award-winning recruitment process to complete your trial.
Navitas Life Sciences Patient Centric Approach to Oncology Clinical Trials
Patient-centricity is about being entrenched in the unique needs of patients, not just about bringing a drug product that will help improve their lives but also about how convenient it is for them to access clinical trial sites. It means reaching out to patients and finding out if supportive services are sufficient and ensuring availability of additional services, like at home medical care, for patients who are unable to travel.
Unlocking Improved Care for Oncology Patients
Dr. Gangaram A.C, Senior Manager- Medical Services, Medical & Scientific Affairs, Navitas Life Sciences took some time to explain more about our support for Oncology Clinical Trials and our key actions to address patient needs in a succinct interview.
Tell us a bit about your professional background
I am Dr Gangaram C, a doctor and a clinical pharmacologist. After qualifying as a clinical doctor, I went on to follow my passion and specialize in pharmacology. Even as a young boy, I was fascinated by the effect of medicine in improving health, helping me choose a career in clinical pharmacology.
As a post-graduate medical doctor, I did extensive research on cancer care, reinforcing my resolve to pursue a career that will help bring better therapeutics for patients in need.
Dr. Gangaram A.C,
Senior Manager- Medical Services,
Medical & Scientific Affairs,
Navitas Life Sciences
Please give us a glimpse of your role at Navitas Life Sciences. How does your role help the broader aspects of improving healthcare?
I think a key aspect of progress in Medicine and, by extension the human race, is when medicines and their effects are properly studied to identify their desired and undesired effects in a formal and reproducible manner. Modern medicine places immense value on the evidence-based approach to a scientific discourse where drugs are tested and re-tested before being approved for use.
At Navitas, I am associated with regulatory affairs and medical content development. My role includes the work behind obtaining the approval for new drugs and existing ones for new diseases. I work behind a 20+ strong team of scientists and doctors who perform tests on subjects, collate the results, assess them and finally create regulatory documents which will form the basis of a health authority’s decision to move forward in approving a drug.
To me personally, I am very concerned about inadvertent side effects and adverse reactions that new drugs can potentially cause, and a large part of my day-to-day role is to ensure that my team captures all of these effects systematically, so that when a new drug is released, healthcare practitioners know what to expect and can weigh the benefits with the side effects of the drugs that they prescribe to their patients.
Some of the drugs that we work with are definitely life-changing and life-saving, especially in cancer care, and it always makes me happy to learn of the positive impact that my work has towards the betterment of society.
How did you become associated with cancer research, especially breast cancer research?
For me cancer research has a special meaning. As a young doctor, I was deeply affected seeing the pain and suffering that cancer brought to patients and their families.
Earlier during my post-graduate days, I would often read late into the night wondering if there was some way to overcome cancer. We see how nature prevents cancers in many animals that then allow them to survive, given the right environment, way past what would be normal for a human.
Just as antibiotics revolutionized modern medicine, more recently, I am keenly interested in how cancer prevention and treatment can genuinely extend human life. With the correct tools, man as a species could easily live past 200 years if we achieve the same level of disease knowledge and pharmacological tools to prevent and treat cancers. What I find even more interesting are the newer discoveries such as viruses and prions that are being implicated in cancer causation, blurring the lines between infective disease and lifestyle-based ones.
Further, my interest in yoga and meditation has been instrumental in exploring palliative care, combining pharmacology with recreational drug use which may increase the life expectancy and quality of life of patients with cancer.
In developing nations like India, where cancer medicines remain beyond the reach of many millions due to lower affordability and poorer living standards, the scope for improving and saving lives is immense. I often see the bread-winner of the family being suddenly taken away by cancer and those families dropping into poverty. This sort of situation only motivates me further to explore solutions that can give solace and hope to countless millions.
On a personal level too, I had a first-hand experience of cancer ravaging through my own extended family, when a blood relative had contracted breast cancer and eventually succumbed. I was already a practicing doctor then and what bothered me the most was the inability of modern medicine to adequately treat neither her underlying condition nor her associated symptoms.
Many types of breast cancer have since become treatable owing to advances in modern medical procedures and pharmacology and I often think of how different the lives of individual families could be with these advances.
On a professional front, I have had the good fortune to interact with and learn from many industry experts and cancer specialists on a one-on-one basis and truly believe that in the next few decades, several life-threatening cancers will be deemed curable with appropriate pharmacological advances.
What is it like dealing with cancer patients?
Allow me to begin the answer to this question by paraphrasing one of my patients from a few months ago, Nagendranath (name changed) who we were treating for throat cancer, which is one of the most common cancers in Asia. He used to compare his life before and after the disease to night and day, saying that the palliative care and to some extent chemotherapy were just like the light of the stars on a moonless night, making a faint but nonetheless perceivable difference. On some days, he used to say he felt touched by the moonlight, especially when he was nearing disease remission. He did eventually succumb to the disease but was able to live a good 18 months longer due to the therapy we were trying, and he was always grateful for his extra time with his family.
I think Nagendranath’s words were profound, resonating with thoughts as a physician and pharmacologist. The difference between normalcy and disease is day and night. Along the lines of Milton’s great literary works, it is truly a paradise lost and my team and I strive hard to restore that paradise, allowing our patients to regain their health.
While many branches of medicine deal with debilitating diseases, none come close to the trauma caused by cancer. It affects everyone around, not just the patients, but their families, friends and even us, as treating physicians. I see many 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.
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
- Safety Management
- Data Management
How do you ensure patient comfort and patient centricity during clinical trials?
Right from the word go, when we begin to enroll patients into trials that we conduct here at Navitas, patient comfort is of utmost importance. We begin by explaining in detail, often in a language the patient is most comfortable conversing in, the details of the trial, including the duration, the type of medicine and how they are supposed to work. Furthermore, at each and every step of the clinical trial process, we ensure that the patient is constantly monitored both at the trial center and via specific 24/7 helplines for any concerns, even when the patient is at his or her home.
In any condition, but especially so with cancer therapies, the patient’s family and close loved ones are kept abreast of the potential, expected side-effects from taking part in the trial as well as how to identify and immediately seek assistance in case of emergency.
Even before a trial begins, our team sifts through thousands of pages of data from animal studies, bio-equivalence studies and any relevant previous data that can help us identify potential adverse and serious adverse events during treatment. We also communicate often and in detail, the results of our initial and continuous monitoring of the patients partaking in our trial with our clients and regulatory authorities and ensure all international guidelines are followed at all times in this regard.
Apart from self-policing, we are also often audited by external agencies which then produce independent reports that confirm our diligence and ensure our continued commitment to patient safety and patient comfort.
What is the ground reality on the use of technology in transforming clinical trials?
Technology is crucial at every step. Patient care, like in any hospital setup, involves the use of a wide variety of diagnostic and imaging equipment as well as lifesaving ones.
On the information technology side, we require robust, secure systems that allow the enormous amount of data to be stored and retrieved easily for future audits by external stakeholders. We also require safe and secure audio and video communication software and tools as well. Once a clinical trial is over, the only way to check for the integrity of data is by maintaining a secure and easily accessible system to check for all of this. Needless to say, data integrity is of paramount importance since sensitive information about the subject and their health is also a part of these recordings. At Navitas, we take this very seriously and are protected by multiple rings of virtual security blankets that ensure the safety and integrity of the data collected via trials.
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 paper-based records and filing systems!
How did you manage to ensure clinical trial continuity during COVID19 restrictions?
The COVID19 pandemic has been a uniquely difficult time for business continuity, not least for clinical trials. But here at Navitas, we were able to maintain an adequate level of functionality without compromising on ethical, regulatory and price considerations.
Looking back, the restrictions imposed were reactionary since the pandemic was sudden and societies all across the world were taken by surprise. I made a conscious decision to plan ahead and owing to my previous experience as well as being in contact with fellow physicians treating the disease on the ground, was able to put in place a comprehensive and robust business continuity strategy.
Right from the start, we had applied for a special permit to continue trial recruitment and progression via a government initiative that allows essential services to continue. This was of course easier said than done! We put in place, a number of social distancing norms within the physical premises of our offices, laboratories and clinical trials’ locations, keeping in mind the safety of our staff and the trial participants.
We ensured that everyone was monitored using a handheld temperature monitoring device and all personnel wore N95 masks. We had similar restrictions for meetings, wherein we used a hybrid model that used both videoconferencing and physical interactions to progress projects.
Once the relevant permissions and permits were obtained, we ensured a constant monitoring system that would notify us about any breaches, which allowed us to monitor all staff both in the clinic and offline for spikes in body temperature, which is still an early warning for viral infections. We initiated immediate quarantine measure for any and all staff who did contract the disease, whether mild or otherwise. A little later, once they were available, we insisted on a complete vaccination schedule to ensure the protection of all personnel.
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. Of course, this came with additional legal hurdles with regard to privacy and additional contracting for all involved; a process which tested the limits of my ability to work remotely. But eventually, 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 any 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 mediated restrictions.
Successfully managing ongoing and new Oncology studies throughout the COVID-19 pandemic
Read our Case study to learn how we maintained business continuity, with the correct infrastructure, logistics, and digitalization to successfully manage Oncology studies throughout the pandemic to bring much needed treatments to those that need them.