There is a plethora of information available online about clinical trials, from the fundamentals to specialized guidance to glimpses of the future. When you’re overwhelmed by clinical trial whitepapers, where do you begin? Here are five things we recommend you read – clinical research whitepapers, along with a guidance document, article and book – to give you new perspectives of the clinical research you work on.
#1 Addressing the Clinical Research Workforce Crisis: A Call for Collective Action
By ACRP
In our collective efforts to bring treatments to the patients who need them, we are currently facing a challenge: according to this ACRP clinical trial whitepaper, the clinical research workforce is “profoundly depleted,” with far more vacancies than jobseekers in many roles, as well as being unrepresentative of the patients we serve. But demands for clinical research expertise are increasing, begging the question: what is required to ensure a global workforce that’s able to meet the growing needs of a busy biotech industry?
The ACRP Partners for Advancing the Clinical Research Workforce (PACRW) aims to address this. It’s a consortium comprising actors from across the industry, including CROs, sponsors and regulatory agencies, working together to ready the workforce for tomorrow’s challenges. This new whitepaper builds on previous publications, with a focus on collaborative solutions that prevent clinical research from being a bottleneck in drug development.
This clinical trial whitepaper presents a solutions framework with actions across six domains:
- Awareness – increasing awareness of careers in clinical research
- Representation – enhancing training and access to careers to improve diversity
- Standardization – improving equity by standardizing roles
- Harmonization – ensuring training is aligned with employment requirements
- Pathway – mapping out a career pathway from entry level
- Identity – creating a recognizable, valuable identity for professionals
Susan Landis, ACRP Executive Director, commented: “We want everyone to get on board to have our profession officially recognized, to build a standard pathway into clinical research as a career, and to better understand the economic contribution the clinical research workforce makes to the device and drug development industry.”
#2 Intelligent Clinical Trials: Using Generative AI to Fast-Track Therapeutic Innovations
By the World Economic Forum and ZS
Even with the most streamlined and efficient clinical trials, the drug development process is slow, taking up to 12 years end to end, at a cost of over $2.5 billion. That’s the context the World Economic Forum and ZS provide for this clinical research whitepaper, which focuses on technology – specifically generative AI (GenAI) – as a way to overcome challenges. It is the third in a collaborative series from the duo.
The whitepaper is based on interviews with life science, pharma, tech, government and NGO leaders, who overall believe GenAI will “revolutionize clinical development and erode the barriers that stand in the way.”
How? This clinical trial whitepaper suggests AI technology will bring change to drug development by enabling decentralization and integrating new streams of data, which include real-world evidence. The whitepaper foresees a future in which GenAI has an impact throughout the clinical trial process, from design and site selection to regulatory submission and data analysis. And there’s also the opportunity to come up with new approaches to clinical research, powered by AI.
The authors also acknowledge the obstacles to this potential future, including insufficient infrastructure and skill gaps, and they call on actors across the industry to come together to make GenAI-powered clinical research a reality.
>> Read the World Economic Forum and ZS whitepaper
#3 Guidance for Best Practices for Clinical Trials
By the World Health Organization
In 2022, resolution (WHA 75.8) “Strengthening clinical trials to improve high quality evidence on health interventions and to improve research quality and coordination” was adopted, leading the World Health Organization (WHO) to develop “Guidance for best practices for clinical trials.”
This sizeable document provides several recommendations, including:
- Participation and engagement – communication, specifically engagement with patients, participants and the community, are at the core of trial planning and implementation to ensure trust.
- Representation – changes aim to make possible trials in typically underrepresented groups, including children, older adults and pregnant women.
- Ethics – the guidance suggests taking risk-based approaches to trial design and oversight when it comes to ensuring clinical trials are efficient, ethical and informative.
- National health authorities, regulatory authorities and funders – recommendations help these bodies facilitate clinical research – a first for the WHO.
The guidance is for anyone involved in running clinical trials, anywhere in the world.
>> Read the WHO guidance document
#4 Integrity of Randomized Clinical Trials: How to Prevent Research Misconduct and Ensure Transparency
By Khalid S. Khan
Transparency is crucial in clinical research today, with increasing requirements to register clinical trials in public-facing databases and publish results, including negative ones. The author of this book – the first book about clinical trial integrity – believes that this transparency, along with ethics and professionalism, guide integrity in clinical research.
Despite the importance of research integrity to the pursuit of drug development as a whole, and to each individual clinical trial, this subject is not widely taught at medical school. This book therefore aims to fill the gap.
However, it’s not just for medical students: this is a useful book for various people involved in clinical trials, including those recruiting participants, funding trials and working in the pharma industry.
Written by Khalid S. Khan, Beatriz Galindo Distinguished Investigator at the University of Granada in Spain, the book starts by exploring the gold standard of clinical research: randomized clinical trials (RCTs) before looking at integrity and ethics committees. It looks at integrity in trial planning and oversight, and includes a chapter on responsible publishing.
>> Read the book published by Routledge
#5 Unlocking peak operational performance in clinical development with artificial intelligence
By McKinsey
Artificial intelligence (AI) is full of promise across all industries, but what can it really do for clinical trials? This article by a team from McKinsey’s Life Sciences Practice explores the potential for AI to impact clinical research, particularly by improving cost efficiency, quality and speed.
The authors identify 12 use cases – areas where AI and GenAI could lead to significant improvements. Here are a few highlights:
- Protocol co-developer – AI could help accelerate the process and reduce amendments by producing summaries and drafts.
- Patient trial companion – with a patient-facing AI tool, dropout could be reduced and patient satisfaction increased.
- Smart data management – by creating databases, cleaning data and more, AI tools could reduce manual queries and increase cost efficiency.
- Regulatory intelligence engine – through competitive label monitoring, questionnaire responses and more, AI could ensure faster responses and fewer follow-ups.
The article concludes with recommendations for getting the most out of AI, highlighting that it’s not just about the technology but also the commitment, vision and adaptation to the tools.
>> Read the article published by McKinsey
Clinical trial whitepapers can be good sources of information, helping optimize various aspects of your own clinical trial. Need more industry insights? Subscribe to our monthly newsletter here.
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