A Journey of a Cancer Researcher Who Sees the Whole Picture! 

Science is not only a pursuit of truth; it’s a promise of hope. For Dr. Shinjini Singh, that promise has shaped every step of her journey. An Indian-American scientist, Dr. Shinjini earned her Ph.D. in Disease-Biotechnology (Cancer Biology) from the Institute of Medical Sciences, Banaras Hindu University, India’s top-ranked university. Her early research focused on detecting p53 gene mutations in Indian breast cancer patients, a breakthrough that continues to aid scientists across the globe in understanding cancer patterns and patient outcomes. 

After moving to the United States, she joined the prestigious MD Anderson Cancer Center as a research scientist. There, her focus shifted to studying the anti-cancer properties of curcumin, the golden compound in turmeric, with the potential to revolutionize cancer treatment. But Dr. Singh didn’t stop at the lab bench. Driven by a deeper purpose, she transitioned to the world of clinical research, where she became involved in cancer clinical trials, bringing science closer to the patient. 

Her work at Cleveland Clinic allowed her to meet the very people whose lives her research aimed to change. Listening to their stories, hearing their gratitude, and watching their determination to contribute to science through clinical trial participation became the most powerful source of motivation. “The way patients would say they wanted to be part of the trial so others could benefit, it was humbling and inspiring,” she reflects. 

Today, Dr. Shinjini continues to bridge the gap between basic science and clinical application, ensuring that her research reaches the very people who need it most. Her unique experience, spanning lab experiments, natural compound exploration, and FDA clinical trials, makes her a rare force in cancer research. 

Her story is not just about data or discovery; it’s about empathy, connection, and a relentless pursuit of hope. It’s a reminder that true scientific impact isn’t only found in publications but in the lives we touch along the way. 

Tackling a Complex Regulatory Challenge in Cancer Clinical Trials 

Regulatory encounters in cancer clinical trials are inherently challenging, as both the disease and its treatments are highly complex. Regulatory timelines and guidelines are extremely sensitive in human clinical trials. Dr. Shinjini recalls a drug trial sponsored by a very renowned Cancer center, which involved a central Institutional Review Board.  

At the time, the implemented protocol required an amendment, and she was new to her role. However, drawing upon her technical expertise and background as a cancer research scientist, she successfully worked on the protocol amendment, gaining approval and implementing it at the institute she was affiliated with. Ensuring that protocol amendments adhere to Good Clinical Practice (GCP) is critical so that the study is always audit-ready for agencies like the FDA. 

Influence of Molecular and Cell Biology Background on Regulatory Compliance 

As a basic scientist, Dr. Shinjini had focused on answering fundamental questions in cancer biology and understanding how disease mechanisms impact human life, eventually contributing to the development of potential cures. Her strong foundation in basic science, which underpins clinical research, has consistently supported her in understanding protocol implementation, as well as making necessary amendments based on ongoing trial data, especially in response to serious adverse events among patients.  

These insights contribute to adjusting chemotherapy dosages and updating the Investigator Brochure (IB), which communicates the risks and benefits of the Investigational Product (IP). Her scientific background further aids in effectively conveying both clinical and non-clinical changes in the protocol to sponsors and clinical, regulatory, and data teams, whether the trial is sponsored or investigator-initiated. 

Ensuring Adherence to CFR and GCP Guidelines 

Dr. Shinjini ensures adherence to the Code of Federal Regulations (CFR) and GCP guidelines by prioritizing tasks based on her role in the clinical team. When consenting patients for trials, she ensures that the correct version of the Informed Consent Form (ICF) is used and that complex scientific information is explained in simple, 8th-grade language so that patients fully understand the risks and benefits.  

She also ensures complete confidentiality of medical information under HIPAA regulations. This meticulous practice continues throughout the trial’s start-up, maintenance, and close-out phases. Whether she is working on patient samples or data collection, she ensures that only de-identified information is shared with sponsors to protect patient privacy. 

Impact of Communication Skills on Trial Outcomes 

In one instance, Dr. Shinjini worked on a medical device clinical trial. The trial had not been updated in a year when it was handed to her. Leveraging her regulatory and communication skills, she was able to update the scientific protocol, get it approved by the Institutional Review Board, and ensure that it met GCP standards. Her ability to communicate effectively with both patients and the clinical team significantly improved patient enrolment, a major achievement in the world of clinical research. 

Managing Priorities While Maintaining Compliance 

According to Dr. Shinjini, patient safety is the most crucial aspect of clinical research. Any component of the clinical trial protocol that touches upon scientific, medical, regulatory, or data considerations affecting patient safety must be prioritized. FDA regulations are grounded in the ethical principles of the Belmont Report and the Declaration of Helsinki, both of which emphasize the protection of human subjects. This ethical commitment drives her prioritization strategy in every project. 

Adapting Quickly to New Regulatory Requirements 

When the SWOG Cancer Research Network (formerly the Southwest Oncology Group) announced an audit of several cooperative group trials at one of the institute, Dr. Shinjini was relatively new to the clinical trials field. She had inherited older studies from a departing colleague.  

Despite the challenge, she worked tirelessly to ensure the studies were up to date with FDA guidelines. Through a rigorous quality check and continuous focus, she successfully passed the audit with no findings. She believes that whether it’s basic science or clinical research, success requires hard work, dedication, focus, and meticulous attention to detail. 

Coordinating Multiple Clinical Research Studies 

Cancer clinical trials are highly complex and come in various formats, including pharmaceutical-sponsored trials, investigator-initiated trials (IITs), and cooperative group trials. Dr. Shinjini manages these studies by categorizing and organizing them accordingly. She is involved in all aspects of clinical research: regulatory, clinical, and data-related. She keeps track of annual tasks like continuing reviews and monthly reviews of serious adverse events, especially those involving off-site patients in pharmaceutical-sponsored trials.  

She gives immediate attention to patients currently on treatment. Her deep understanding of different protocol sections, particularly those involving direct patient contact, helps her structure her daily routine effectively. Tools like Outlook reminders and OneNote assist in organization, but her grasp of the protocol is what keeps her focused and ahead. 

Teamwork and Conflict Resolution in Clinical Research 

During her PhD, Dr. Shinjini wrote a complete protocol that led to significant funding for her supervisor’s lab, benefiting future PhD students. While at MD Anderson Cancer Center, she was encouraged by her professor to involve the entire lab in writing a book chapter, which she authored as the first author for SpringerLink publications.  

This collaborative effort helped develop her teamwork and leadership skills. She believes that leadership is not just about personal development but also about empowering others to grow professionally and personally. In clinical research, she has learned that differing opinions and conflicts should never be taken personally and must be resolved with maturity, always keeping patient safety and scientific progress as the shared goals. This philosophy guided her as a leader in three hematological cancer groups and a device trial. 

Enhancing Critical Evaluation Skills Through Editorial Work 

Dr. Shinjini began her journey as a reviewer and editorial board member for internationally reputed journals when applying for a U.S. Green Card under the EB1A (Extraordinary Ability) category. This experience significantly deepened her understanding of cancer research.  

Reviewing hundreds of manuscripts worldwide sharpened her attention to detail, improved her ability to extract key insights quickly, and enhanced her understanding of clinical trial requirements from multiple perspectives: scientific, clinical, medical, regulatory, and data-driven. This experience has significantly elevated her capabilities in her current role. 

Communicating Scientific Complexity to Non-Experts 

Dr. Shinjini’s work often involves translating complex scientific and regulatory concepts into understandable terms for non-expert audiences. One notable example is her work in consenting patients for a trial funded by a major pharmaceutical company.  

She ensured that all information was conveyed in simple, 8th-grade language, enabling patients to make informed decisions. Her ability to communicate clearly and compassionately played a crucial role in ensuring transparency and patient trust. 

Staying Motivated Through Scientific Translation 

Dr. Shinjini finds her motivation in witnessing the full cycle of translational research, from bench science to clinical application and back to the lab for further refinement. Scientific discoveries must eventually reach patients, and this requires a deep understanding of cellular and molecular mechanisms as well as the pathways involved in novel therapies.  

She believes that insights gained in clinical settings often inform the next wave of basic science research. This ongoing feedback loop drives her passion and commitment to her life’s goal: bringing new therapeutics to the world and improving lives globally. 

Vote of Thanks: 

Dr. Shinjini believes I’m just a medium of Shiv and Shakti to do their work for the betterment of society and to help make people’s lives better through my work. My entire journey from being a basic scientist to being in clinical trials and the future would not be complete without being grateful to the most important people in my life. As they say, “It takes a village!” 🙂 My dad, Dr. O. P. Singh, was Dean and Professor & Head, Department of Anesthesiology, BRD Medical College, Gorakhpur, India. I am who I am because of my parents! Thank you, Mummy (Mrs. Asha Rajput), for being awake for countless nights with me during all my examinations! Bringing me up so elegantly with always giving emphasis to my studies, sports, and, above all, being a good human being! Dad, you were my guru and my best friend!! The most dynamic, genius, and amazing personality I ever met… who touched and changed countless lives as a teacher and as a doctor! See you in the next lifetime!! Always be with me and keep blessing me! 

Anuj, my better half, my best friend, my strength, my pillar… Like Shiv & Shakti, we are one energy! I’m glad to share this whole path with him in this lifetime. He has been my unwavering pillar of support through every step of this journey. He has stood by my side with endless patience, love, and encouragement. His belief in me, even during the toughest times, has been my strength. Thank you for being my constant source of motivation and for always being there for me. Anuj Srivastava works as a senior data engineer at Lubrizol, a Warren Buffett company in Cleveland, OH, USA. 

Gratitude to my most loving father-in-law, Dr. S. K. Srivastava, MD, who was always proud of me, and I know he’s blessing me from heaven. I miss him so much! He retired as Director General, Health Services, UP Government, India. My mother-in-law, Mrs. Mala Srivastava, for always loving, caring for, and supporting me in all the possible ways! For always being proud of my hard work and perseverance. 

My utmost regards and gratitude to all my teachers right from kindergarten until the present. Special thanks and loads of love and gratitude to my sister and both my brothers-in-law: Shalini Singh, Pankaj Singh, and Akshay Srivastava! My aunt, Mrs. Usha Mehra a civil servant, and all my childhood I grew up looking up to her. All my friends, especially during my PhD, and my childhood best friend, Dr. Shalini Shukla, who’s a constant support. 

Most importantly, I’m extremely grateful to all my clinical trial patients. I work hard and try my best to do the best work that I can to make patients and their families’ lives better and to make the future of medicine and healthcare brighter and brighter! 

Thank you to everyone who has been part of my journey, whether by standing beside me, cheering from afar, or simply believing in me. This is just the beginning, and I promise to continue working hard, sharing what I have learned, and supporting others on their paths. Here’s to all the dreamers out there; let’s keep pushing forward, one step at a time. With gratitude, Shinjini. 

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