Navitas Life Sciences has been supporting efficient clinical trials for over 30 years, partnering with small to large pharmaceuticals, Life Sciences companies, and U.S. Federal agencies to bring life-saving medicines to the global market. Transforming health and healthcare has been, and continues to be, a priority and supporting patient needs must begin even before trial initiation.
Patient-Centric Clinical Trials and diversity at Navitas Life Sciences
One of the critical steps in a patient-centric trial at Navitas Life Sciences is about explaining the entire trial process to patients and volunteers of a study, with key insights provided at various junctures.
Another vital step is to include the needs of the patients and the support required to inform the study design, this way, there has been sufficient thought and planning woven into the trial design to improve patient comfort. A single procedure may not be a cause of discomfort for the patient, but when it is coupled with stringent regimens and it hasn’t been well planned out, it can be.
For example, a blood sample collection may not be a cause of concern, unless there are multiple samples to be collected at specific intervals. However, this requires effective support for transportation, food, or even a place to stay, so that study participants have limited discomfort and/or inconvenience. A well thought out plan, with patient experience in mind, helps in tailoring suitable supporting measures, even before the start of the study.
Patient-centricity is a focus not only for patients who take part in the study but is a focus for the multiple patients who will subsequently use the drug product when it reaches the market.
The Importance of Being Diverse
In line with being patient-centric, our Senior Clinical Research Associate, Betsy Knight, spoke to us recently about diversity in clinical trials and its importance, continue reading for some of the insights that came from this recent interview.
Tell us about your career journey?
I have been in this field for many years. Initially, I didn’t realize that medical science would fascinate me as much as it has. I started out as an office manager at a large neurology center and the Principal Investigator of a clinical trial encouraged me to become the Study Coordinator. One of my monitors referred me to KAI Research (now NCR) as a Clinical Research Associate (CRA). My first study was a large Phase IV study and we managed it well.
I remember the first time as a study coordinator when we did an electronic case report form, we had to plug it the computer into the telephone to transfer the data. I worked with the sponsor to update their database so headers and visit dates would populate automatically. This was many years ago, and we have come a long way. It has been a long and wonderful career and, as both an industry and a company, we have evolved and adapted with the changes in the clinical trial field.
Sr. Clinical research Associate,
Navitas Clinical Research
Why are diverse participants important in clinical trials?
We need to be able to include a diverse population when we are conducting clinical trials. This will help us understand drug response(s) across different ethnic groups. A lot of minority groups, especially in the U.S, don’t get the right medical care, and one way of ensuring that is to include them in clinical trials.
How can diversity be improved in clinical trials?
The most important step is to find out how to reach this population. The Public Health Service, who provide medical care in underserved areas, may be an avenue to pursue to see if they can be tapped into in order to encourage people from such areas to participate in trials.
Can clinical research studies should be included as part of the Medical School curriculum so that when graduates come out of medical school, they will know how to go about it. A lot of physicians now are unaware of the process.
A pharmaceutical company and a site maintenance organization recently joined together to bring diversity into clinical trials. More such initiatives are required to try and get underserved populations into clinical trials.
What are the challenges faced in including diverse participants in clinical trials?
There is a lot of mistrust of medicine in a lot of areas in our country and clinical research may help with that but we have to break this barrier. We have to get the physicians involved. A lot of times people do not have access to the clinical trials.
We have to do a better job of educating people, including physicians and health care workers, to try and get a more diverse population for clinical trials.
How will partnering with a global CRO aid in improving diversity?
A global clinical research organization, like Navitas Life Sciences has access to multiple patient populations and volunteers, which will aid in improving diversity in the clinical trial population.
Navitas Life Sciences has more than 25,000 healthy volunteers, with 700 post-menopausal women, and patients with cancer, diabetes, hypertension, and renal disease to name but a few.
5 Ps to Enhanced Patient Experience with Navitas Life Sciences
- Patient Awareness
- Patient Centricity
- Patient Comfort
- Patient Engagement
- Patient Safety
In the most complete articulation, patients and volunteers who participate in our studies are the prime focus, with the extension of the right resources and technologies to ensure a smooth transition through the clinical trial process.
Case Study: Successful Registry and Data Coordinating Center Support for Parkinson’s Foundation’s Parkinson’s Disease GENEration Registry
The Parkinson’s Foundation required the services of an experienced clinical research organization as the Registry Coordinating Center supporting their large genetic registry program.
Find out how our expert team
- Streamlined process and support to over 90 sites
- Provided efficient and effective data management and quality control
- Ensured successful Integration of the clinical data of nearly 2000 patients with the genetic data
- Shared data sets with The Global Parkinson’s Genetics Program (GP2), National Institute on Aging (NIA) and the Michael J Fox Foundation