Pharmaceutical Outsourcing Q3 2023 - 17

CLINICAL TRIALS
SECTION TITLE
3 involves a larger participant pool of 300 to 3,000 individuals. The
duration of Phase 3 can vary from 1 to 5 years, and the drug approval
rate at this stage is approximately 25%.4
The overall process of drug development leading to final approval
involves navigating numerous challenges and adhering to regulatory
requirements. It typically spans several years, reflecting the complexity
and rigor involved in bringing a new drug to market.
The process of discovering and developing a new drug is timeconsuming,
expensive, and carries inherent risks. In a competitive
market, small pharmaceutical companies may face challenges and
potential delays in bringing a new drug to market. According to
Deloitte, the average cost of developing a new drug among the top
20 global biopharmas it studied rose 15% ($298 million) last year,
to approximately $2.3 billion.5 However, they can mitigate these
obstacles by carefully analyzing and addressing the major risk factors
associated with conducting a successful clinical trial.
Studies indicate that a key determinant of a successful clinical study
is to efficiently recruit and retain an adequate number of the study
population. Finding and enrolling a sufficient number of eligible
participants within the desired timeframe can be challenging. Strict
inclusion and exclusion criteria, limited awareness among potential
participants, and logistical barriers may contribute to recruitment
difficulties. Globally, more than 80% of trials fail to enroll on time
resulting in an extension of study and or the addition of new study
sites.6 Similar to enrollment is the retention of patients and ensuring
participants adhere to the trial protocol and remain engaged
throughout the study duration. This is crucial for generating reliable
data.
But patient recruitment and retention can be challenging due to
various factors like:
* Participant lack of motivation
* Logistic burdens for the participants to travel to the sites
* Interference with work commitments or family responsibilities
* Lack of patient engagement
leading to patient dropouts. This can cause substantial delays and
impose significant financial burdens on trial sponsors.
One solution which can address the above issues are Decentralized
Clinical Trials.
The COVID-19 pandemic has necessitated the widespread adoption of
technology in various aspects, including clinical trials. This has led to
the emergence of decentralized clinical trials (DCT), which encompass
remote screening, enrollment, e-consent, patient engagement, and
ePRO (patient-related outcome) measures.
Small and medium-sized biopharmaceutical companies can leverage
decentralized clinical trial platforms for their clinical trials. By utilizing
such platforms, these companies can benefit from accelerated
remote pre-screening, e-consent processes, and efficient referral to
enrollment sites. Patients can be actively engaged through various
digital means like email, SMS prompts, audio, and video messages.
Tele-visits can offer a solution to alleviate travel burdens. Additionally,
the use of reusable cloud infrastructure and automation can minimize
manual and repetitive tasks, streamlining trial operations.
Clinical trials can be resource-intensive and costly endeavors.
Securing sufficient funding, managing trial budgets, and allocating
resources effectively are ongoing challenges, particularly for small
and medium-sized companies with limited funding opportunities.
Leveraging technology for patient recruitment, constant engagement
to prevent patient dropout, minimizing site visits, and streamlining
data collection and monitoring can help overcome some of the
persistent challenges faced by trial sponsors.
References
1.
" What is a Pharmacopeia? | Quality Matters | U.S. Pharmacopeia Blog. " USP - Quality
Matters, 7 August 2014, https://qualitymatters.usp.org/what-pharmacopeia. Accessed 14
July 2023.
2. " FDA History. " FDA, 29 June 2018, https://www.fda.gov/about-fda/fda-history. Accessed 14
July 2023.
3.
" A History of the FDA and Drug Regulation in the United States. " FDA, https://www.fda.gov/
files/drugs/published/A-History-of-the-FDA-and-Drug-Regulation-in-the-United-States.
pdf. Accessed 14 July 2023.
4.
" Investigational New Drug (IND) Application. " FDA, https://www.fda.gov/drugs/typesapplications/investigational-new-drug-ind-application.
Accessed 14 July 2023.
5. " Pharma R&D return on investment falls in post-pandemic market. " Deloitte, 9 January
2023, https://www2.deloitte.com/uk/en/pages/press-releases/articles/pharma-r-d-returnon-investment-falls-in-post-pandemic-market.html.
Accessed 14 July 2023.
6. Desai, Mira. " Recruitment and retention of participants in clinical studies: Critical issues and
challenges. " NCBI, 6 May 2020, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342339/.
Accessed 14 July 2023.
Dr. Harsha Rajasimha is the founder and CEO of Jeeva Informatics
Solutions, based in Virginia.The personal experience of losing
a child born with a rare congenital disorder and a brother
with a chronic disease became the springboard for Dr. Harsha
Rajasimha to apply his years of postdoctoral training at the NIH
and FDA to accelerate therapies for rare and common conditions. Patient travel
requirements and the pandemic forced the demand for decentralizing clinical
trials and embracing digital technologies needed to accelerate the process of
bringing new medicines or vaccines to patients who need them over three times
faster. Jeeva set out to focus on mitigating risks to emerging biopharma clinical
trial sponsors as true technology partners, seeking time and cost-efficient ways
to execute early-stage clinical trials with minimal risk without compromise.
Their reduction of the logistical burdens on patients and study teams by over
70% has resulted in their eClinical platform being selected by a joint venture of
Georgetown University Medical Center and Frantz Medical Group for a major
cancer trial. The Virginia-based company's modular software-as-a-service
platform is fully scalable and facilitates patient enrollment, engagement, and
evidence generation in clinical trials on any browser-enabled mobile device.
Visit https://jeevatrials.com/.
Dr. Padma Rammoorthy has a career spanning over 26 years.
She has transitioned from clinical practice to health education
and lifestyle medicine in her career. Having made significant
contributions to raising awareness about maternal health in
India and worldwide through her successful social start-up, she
has been honored with prestigious awards such as the India Innovation Growth
Program and the World Summit Award
pharmoutsourcing.com | 17 | July/August/September 2023

https://qualitymatters.usp.org/what-pharmacopeia https://www.fda.gov/about-fda/fda-history https://www.fda.gov/files/drugs/published/A-History-of-the-FDA-and-Drug-Regulation-in-the-United-States.pdf https://www.fda.gov/drugs/typesapplications/investigational-new-drug-ind-application https://www2.deloitte.com/uk/en/pages/press-releases/articles/pharma-r-d-return-on-investment-falls-in-post-pandemic-market.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342339/ https://www.jeevatrials.com/ http://www.pharmoutsourcing.com

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