Blood Cancer Awareness Month: Navitas Life Sciences is your Strategic Partner for End-to-End Oncology Clinical Trials

September is #BloodCancerAwarenessMonth to raise awareness about the various blood cancers and the efforts being taken to find suitable treatment. Navitas Life Sciences supports your aspirations to bring life-saving medicines to the market through well-managed clinical trials.

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End-to-End Clinical Trials Partner

With over 30 years of experience in conducting clinical trials, we understand key challenges and have established systems to run a successful oncology trial. Right from phase I to phase IV, we support clinical trials from startup to closure, and beyond, with our regulatory insights and quality approach. Our services are backed by technology & analytics that are developed specifically to meet challenges, providing a competitive edge.

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.

How does an oncology clinical trial compare to the trials of other therapeutic areas?

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 organize, document, store and interpret it. In my mind, two of the most crucial factors that go into making a good clinical trial include personnel and technology.

Oncology trials tend to be somewhat more complicated than trials that focus on other therapeutic areas. While in most regular trials, the endpoints are focused on the safety and efficacy, an oncology trial is conducted to enhance a individual's quality of life.

One of the vital differentiating factors in oncology trials is that there are no placebo arms when there is a standard therapy that exists. In trials that focus on other therapeutic areas, it is common to have a placebo arm along with the study arm where the drug of interest is being studied.

Dr Gangaram A.C, MD

Senior Manager Medical Services,

Navitas Life Sciences

Adverse events reporting for non-oncology trials is scored as mild, moderate or severe, while in oncology, there are numeric grades that are used based on the guidelines provided by the National Cancer Institute: Common Terminology Criteria for Adverse Events (CTCAE).

There is also a challenge in patient recruitment for oncology trials as sometimes more sites are required to fulfill study participant requirements, leading to higher costs.

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What are our 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 tumors types. Although many specifics of the therapy are private, I'd like to respond to this topic first from a more patient-centric standpoint, then from a regulatory perspective, and then from a COVID-19 perspective.

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 loved ones are kept informed about the potential, expected side-effects from participating in the trial as well as how to recognize 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 organizations, that corroborate our diligence and guarantee our ongoing dedication to patient safety and comfort.

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Last but not least, the COVID19 pandemic has presented a particularly challenging period for business continuity, especially for clinical studies. But at Navitas Life Sciences, we were able to keep the functionality up to par without sacrificing moral, legal, or financial considerations.

I played a key role in the conception and implementation of a customized IT system that would enable remote video-based trial monitoring, enabling regulatory authorities, clients, and auditing firms to access and witness the trials live and record them for later auditing. This approach, which tested my capacity to work remotely, came with extra legal challenges related to privacy and required further contracts for all parties.

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.

Overall, I'm pleased to report that despite having to nearly double our time commitment to projects, we had essentially no delays in achieving either our client's or the government's regulatory objectives during the pandemic limitations.

IDMP

How do you manage clinical operations in oncology trials in the U.S and across the world?

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.

The business development team works closely with the clinical development and operational teams from the project's inception date to determine its viability. The internal teams then send out initial requests via email, in person, and over conference calls to further narrow down the precise sites, physicians, and support services that are best suited for the studies' criteria after analyzing the study criteria and using legacy information-based forecasting.

At this point, each criterion is examined for any potential clinical implications that COVID or another factor may have on the sites selected in terms of patient loads. Finally, the necessary legal and regulatory frameworks for consent and NDAs, among other things, are recorded and prepared.

Depending on the degree of patient population scarcity for the specific sub-specialty and cancer, the complete process could take anywhere from two weeks to several months. A substantial quantity of input patient loads is present in trials that span a sizable geographic area with a sizable population. However, the distribution may be more dispersed between regional institutions. Because of this, lists of specialties must frequently be updated, necessitating site inspections.

What are the endpoints in oncology clinical trials?

In order to evaluate the security and effectiveness of novel cancer medicines, clinical endpoints are crucial. Oncologists use them to assist in directing clinical decision-making. Overall survival (OS), though commonly regarded as the "gold standard" primary clinical outcome, has a number of drawbacks that limit its usefulness. A current drive to investigate surrogate clinical endpoints and their potential to act as primary clinical endpoints in place of OS has been motivated by the time-consuming nature of trials using OS. As their usage in oncology clinical trials increases, it is also becoming clear that other endpoints contribute vital information concerning quality of life and treatment failure. The use of clinical endpoints will undoubtedly increase and grow as new cancer medications are created and innovative treatments, like immunotherapy, gain popularity. The functions of primary and surrogate clinical endpoints, as well as the advantages and disadvantages of each particular endpoint, are examined in this article. Additionally, it compares each directly and highlights some of the particular functions that each one does.

Overall Survival (OS)

Overall survival, or OS, measures how long patients, who undergo a certain treatment regimen, live compared to patients who are in a control group (i.e., taking either another drug or an inactive treatment, known as a placebo). If a clinical trial demonstrates improved OS, it provides evidence of the drug’s value in prolonging a cancer patient’s life. OS is a strong and precise endpoint, as it requires having more patients and longer follow-ups compared to other clinical trial endpoints. Given all this, OS is often considered the “gold standard” for measuring the clinical benefits of a cancer drug.

Progression-Free Survival (PFS)

Progression-free survival, or PFS, is another vital endpoint for to measure the effectiveness of cancer drugs is – how long a person lives without the disease worsening. PFS results are typically available earlier in a trial than OS data. PFS is considered an indication of disease control and stabilization.

Overall Response Rate (ORR)

Overall response rate, or ORR, is the proportion of patients in a trial whose tumor is destroyed or significantly reduced by a drug. ORR is the sum of complete responses (CRs) – patients with no detectable evidence of a tumor over a specified time period – and partial responses (PRs) – patients with a decrease in tumor size over a specified time period. Improved ORR offers tangible proof that the drug is working.

Duration of Response (DoR)

Duration of response, or DoR, is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. Cancer drugs that demonstrate improved DoR can produce a durable, meaningful delay in disease progression, as opposed to a temporary response without any lasting benefit

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.

Full Service Clinical Trial Support for a First-in-Human Phase I Dose Escalation
Oncology Study

Our client, a US based company, were initiating a First-in-Human Phase 1 dose escalation Oncology Study. As a result, they were seeking full service clinical trial support to include:

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

Download the Case Study and learn how we worked seamlessly with our client to deliver efficient and effective full-service clinical trial support for this complex study.

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Reference:

https://short-facts.com/what-is-objective-response-rate/