Editor’s Note: Kamnesh Pradhan is a pediatric hematology-oncology specialist who became a principal investigator conducting oncology clinical trials before joining Lilly’s oncology research division in 2019. We asked him about his experience and what advice he would share with other physicians considering a role in research.
In my own experience, it took many years of consideration before I switched from pediatric hematology-oncology specialist to principal investigator to finally joining Lilly as a study sponsor.
I did my pediatric training in Chicago and then came to Indiana University in 2000 to do my fellowship training. One of my senior fellows at the time became faculty and was a good friend and mentor. He worked at Lilly and saw patients at the same clinic as me every Tuesday. Since I was so interested in clinical trials and drug development, he recommended that I join him at Lilly.
So I gave it a go and interviewed in 2006, but after visiting several times, I decided that I wanted to get more experience under my belt. Fast forward eight or nine years later, and I got the opportunity to run a couple of Lilly trials. I became one of the national principal investigators for one of their studies. At that point, I had great experience in clinical trials from the viewpoint of the investigator conducting the trials, and I thought it would be interesting to see what it would be like from the sponsor side of clinical trials. I interviewed again at Lilly and have been working here for about two years now.
By this point, I had a lot of experience from a site perspective, but my learning curve was steep from a sponsor point of view. On the other hand, some of my Lilly colleagues didn’t have the site experience that I did, so we are able to learn from each other.
If you’re a physician interested in getting involved in clinical research, you must understand that it can be a big career shift, and there are a few key questions to keep in mind: from finding your motivation to understanding the differences between standard clinical care and clinical trials.
What’s your motivation?
Most importantly, you need to think about why you want to become an investigator. Understanding your motivation will help you determine if this is the right move for you.
Common motivators that I’ve heard include:
Your patient has an unmet medical need, and you want to be able to provide them with new care options. You have to advance science in order to do this. Basic research leads to drug discovery, and new drugs can only be useful if they’re tested and approved. Then, you can see how your work in research can benefit your patients’ care.
You’re interested in furthering your academic advancements. It’s great to think about broadening your expertise and progressing your career! It’s helpful to map out where these new learnings can take you next.
Do you have resources at your site?
Some people think that you can just sign up to be an investigator, but there are many other pieces you need in place in order to be successful. For instance, you need a research nurse to work directly with the patient, regulatory personnel who will do regulatory submissions at your local institution, and a study coordinator who will ensure data integrity, all working together with the sponsor.
Often, the investigator has to invest in his or her own infrastructure to make sure they’re capable of producing the best result. You need to talk to your leadership to make sure everyone is supportive, and you need the right team to deliver the very best to your patients. Having the right resources and team will ensure that you gather good data, because without good data, no new medicines will get approved.
Do you understand the differences between standard medical practice and care in clinical trials?
As you’re considering a career in clinical research, you should know that it will be very different from the medical practice you’re used to. In clinical trials, you’re following a protocol. This protocol will be different depending on the phase of research and the purpose of the study you’re conducting, but no matter what, it must be followed precisely.
When you’re in a medical practice, you know that the disease isn’t black and white, so you’re able to adjust accordingly throughout the patient journey. However, in a clinical trial, it’s critical from a safety and regulatory perspective to not deviate from the study protocol.
Another aspect that’s different: in standard medical practice, you don’t have a set number of patient visits. This is where the phase of research comes in. For example, early in the development of a drug, a patient may need to be seen as often as often as weekly, whereas later in development when more is known about the drug, patients will have more flexibility with fewer office visits. You will need to know the requirements set forth in the protocol, and you need to be transparent and communicate that with the patient and their family caregivers up front so that they can decide if the frequency of visits will work for them.
An advantage to being a part of a clinical trial is that it appeals to a patient’s altruism, and they can know that they’re contributing to science and research. No matter what the study finds, their participation still progresses us all forward. You don’t get this type of feeling in standard medical care.
Interested in learning more? Connect with Lilly Trials on Twitter and Facebook to stay up-to-date on the ins and outs of clinical trials. If you are a health care professional interested in conducting clinical trials with Lilly, please call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) and follow the prompts to indicate your interest in Lilly Clinical Trials and speak with a representative.