Behind the research: Nitika Neha

Can you tell us what led you to your current role?

I’ve worked in clinical trials for the past 7–8 years. I was a Clinical Trial Manager, working on investigator-initiated trials where I first learned about clinical trial management.

What drew you to research and clinical trials?

I’ve always loved science. I took it one step at a time. I did a master’s in biotechnology and worked in a niche field called metabolomics, which is kind of like genomics – but instead of looking at genes, you’re analysing cellular metabolites.

I was always interested in clinical trials. You’re asking an important clinical question and the answers matter. You get to apply science in real life. You can see the impact close-up, like improving health outcomes or the patient experience.

How does an investigator-initiated clinical trial start?

It all begins with an enthusiastic clinician. They bring us an idea, and we support them to develop the project.

First, they submit a research proposal which is reviewed by Icon. Once this is approved, we work with the clinician to build the study protocol which outlines the clinical questions, assessments required to answer those questions, the patient population, main timelines, requirements for ensuring a high-quality study and a budget.

We engage additional expertise from biostatisticians and any other clinical specialists to get a scientifically and clinically sound protocol. These are the most important steps, because the protocol identifies all the requirements of the study.

Once a protocol has been finalised the project needs to undergo ethical and governance reviews. We coordinate submissions for these reviews to ensure projects have had the required reviews and approvals in place. In parallel we would also be developing other required project documents such as, laboratory manuals and the database which is used to collect data generated from the study.

Our team ensures that all ethical and regulatory requirements have been met before a study can be opened. Once a site is activated, we work closely with the site to ensure the trial is being run according to required standards and regulations.

What challenges do you face in your role?

The biggest challenge is time. Our clinicians are understandably very busy caring for patients. Research isn’t usually their primary role, so keeping a project moving on top of their clinical workload takes coordination.

There’s a lot of work behind the scenes. Research relies on a huge amount of coordination and support across different teams.

How do you balance the clinical side of research with real-world patient impact?

We rely a lot on the clinicians. Once we have a protocol, we get independent reviews and consult with sites to make sure the protocol is feasible and not too complicated for the patient.

We want a protocol that is workable but not overly taxing on the patients. That input comes from the clinicians and Clinical Research Coordinators (CRCs), who can tell us what’s practical and we adjust based on that.

Have there been any projects you’ve worked on that stood out to you?

Each study has taught me something new. There was a learning curve, coming from a medical oncology and pharmacology background into radiation oncology.

The ERASE study was the first project I worked on at Icon from the start and soon we’ll see patients. It’s a big milestone for me.

Why are investigator-initiated trials (IITs) important?

I think IITs address unmet needs – not from a commercial point of view, but for patients.

Investigator-led research often explores ideas that wouldn’t get commercial funding – but they matter deeply to patients. These trials bring new insights in ways we might otherwise miss.

For example, the COMPRESS clinical trial I’m working on is trying to address peripheral neuropathy in patients who’ve received chemotherapy. That’s not something a drug company would likely explore, but it makes a real difference to the quality of life of patients receiving chemotherapy where peripheral neuropathy is a common side effect.

I think IIT’s are very important for bringing a focus to studies in areas which may not get attention otherwise.