There is a plethora of information available online about clinical trials, from the basics and fundamentals 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 – whitepapers, reports, articles and books – to give you new perspectives of the clinical research you work on.
Preparing for a New Data Future: A Survey of Clinical Research Technology Decision Makers
This white paper gazes into the crystal ball of data and tech in clinical research. Medidata conducted in-depth interviews with senior technology decision makers representing 31 companies in total – 22 manufacturers and nine CROs.
The white paper covers six data trends identified through analysis of the interviews, including the acceleration of virtual solutions for clinical trials. There has been an acceleration in the digital revolution in clinical research due to COVID-19, and many of the trends identified are likely to have been boosted by the pandemic.
What is clear from the survey is that access to data is increasingly important, and companies running clinical trials want to use the cloud – and they are happy to work with vendors for their electronic systems.
Navigating Clinical Trials in the Coronavirus Era
This short report provides approaches sponsors can take to mitigate risks to patient safety during trial as the Coronavirus pandemic continues.
The report outlines the impact of the COVID-19 pandemic on clinical trials, in particular the additional challenges patients will have when required to attend in-person visits.
Science37 provides a tech solution that can help sponsors carry out remote appointments with study participants – ‘telehealth’, as Science37 calls it. The report underlines the importance of patient centricity during the crisis, and how thinking from their perspective can help sponsors make decisions about business continuity.
The report proposes some practical strategies: virtual meetings, telehealth appointments with physicians, at-home visits from nurses and shipping medication. It also lists a number of considerations that will be important when deciding the approaches to take to ensure trials continue during the pandemic, highlighting the need for flexibility.
Reporting the Findings of Clinical Trials: a Discussion Paper
By the World Health Organization
This discussion paper outlines the principles behind the World Health Organization’s (WHO’s) stance that “the findings of all clinical trials must be made publicly available”.
Despite being ethically, and often legally, obliged to publish the results of clinical trials, both positive and negative, there is a lot missing from the public record. A decade ago, the WHO Registry Platform Working Group on the Reporting of Findings of Clinical Trials proposed the position that findings should be publicly available.
In this paper, the Working Group explains the principles behind the proposal, discussing in depth what a finding is and what public availability means. It is a useful paper for anyone working on a clinical trial to read, in order to understand the importance of transparency of results.
How to Avoid Common Problems When Using ClinicalTrials.gov in Research: 10 Issues to Consider
By National Institutes of Health
This article in the BMJ covers ten things to consider when using ClinicalTrials.gov as a source of research information.
Organizations working on clinical trials might not look at their work in the context of other studies, but this article provides a different perspective that could be useful when planning and conducting a trial.
Clinical trials should be registered, and the results published; every trial adds to the body of scientific knowledge. Researchers use the information in databases like ClinicalTrials.gov and the European Union Clinical Trial Registry to “assess research reporting practices, or to characterise the clinical research enterprise.” To do this effectively, they need to understand the database.
The BMJ article starts with the basics – what ClinicalTrials.gov is and how it works. This is useful information for anyone working on a clinical trial. It then goes into detail on ten aspects researchers can consider, from the completeness of the records to the incentives for reporting.
Principles and Practice of Clinical Research, 4th Edition
The main reference book for conducting clinical trials, this is now in its 4th edition. The book covers the fundamentals of clinical research as well as the practical side.
The book explores every aspect of clinical research, including ethical principles, data management, and working with the media. Originally published in 2002, it has been updated regularly to include the latest developments in clinical trials. The 4th edition includes information about big data and electronic records, for example.
Principles and Practice of Clinical Research is written for anyone involved in clinical trials, including researchers, physicians and students.