“What would have been unthinkable before became feasible in the interest of patient safety”

Temporary accommodations made to weather the COVID-19 pandemic could accelerate lasting reform of clinical trial methodology.
Ahmad Awada
awada-ahmad

Dr Ahmad Awada

The increase in bureaucratic and administrative procedures in clinical research is widely denounced as a barrier to its progress (ESMO Open 2020; 5:e000662). Changes in practice made in the course of the COVID-19 pandemic to allow clinical trials to continue are currently the focus of a review work within ESMO, providing new insights into which processes work in the interest of cancer research and which work against it. Dr Ahmad Awada, Jules Bordet Cancer Institute, Brussels, Belgium, is a member of the ESMO Clinical Research Observatory (ECRO) Task Force and believes the lessons learnt will help the research ecosystem to restore order with a new set of priorities.

Has this health crisis shifted the debate on bureaucracy in clinical research? 

Yes, undoubtedly. I have been involved in clinical research for more than 30 years and I have seen the administrative burden grow exponentially with the amount of mandatory data to collect and processes to document, because of exceedingly conservative interpretations of the applicable rules and regulations. At the time of the initial outbreak of COVID-19, we had many patients already enrolled in clinical trials for whom treatment, management and follow-up had to be adapted rapidly to social distancing and other new imperatives. We started receiving letters from contract research organisations (CROs), academic groups and trial sponsors calling for adjustments to be made in our procedures. Suddenly, things that would have been unthinkable before became feasible in the interest of patient safety.

Could any of these adjustments improve the efficiency of research procedures?  

The important thing now is to recognise that some obligations we used to consider immovable are actually not set in stone. For example, we allowed patients to get their CT scans, blood tests and blood pressure taken at local facilities near their homes. Why did patients previously have to come to the original hospital for all these things, even when they lived far away? Another unprecedented move was allowing us to obtain patients’ oral consent over the phone to approve amendments to their informed consent. There are many more examples that I am currently compiling into a list. However, these will require detailed analysis and discussion before we can make a qualitative judgement regarding which changes could be made permanent.

Have you seen any changes that could impact the quality of research? 

Of course, we should be careful about intervening in the methodology of clinical trials: adherence to regulations like the Good Clinical Practice (GCP) guidelines is of the utmost importance to ensure our patients’ interests and safety are served. While it is true that we have relaxed certain aspects of our procedures during the crisis, I still think it is unlikely that we would ever go from one extreme to another.

What is undermining the quality of our research, meanwhile, is treating all administrative tasks as if they were equally important. Yes, our findings in the clinic need to be put on the record: their interpretation will inform the treatment of further patients. However, we currently collect massive amounts of unclassified, unprocessed information in electronic files: I am sure that half of it is never used at all. We spend all this time filling in forms and logs, without understanding why and without adding any value to the research itself.

Can the experience of the pandemic help distinguish between what is important and what is not? 

Some of the data we collect has little or no chance of ever being used – but in most cases it is not that simple. Enormous progress has been made in oncology in recent years: in our understanding of cancer and its molecular biology, but also through new therapies and technologies. This has not been matched by an evolution of our clinical research methodology. What the experience of the last few months can help us to do is prioritise our tasks and create hierarchies for the information we need to collect according to its real value for our research. What is essential is well-known, but we have now seen that many things that used to be deemed mandatory could be classed as secondary or even optional. The real silver lining of this terrible health crisis lies in the fact that it made major changes in practice possible very quickly, some of which we will now be able to argue in favour of upholding.

What the experience of the last few months can help us to do is prioritise our tasks and hierarchise the information we need to collect according to its real value for our research.

Dr Ahmad Awada

What impact do you think the lessons learnt in the COVID-19 era could make on future oncology research?  

Before the pandemic, we were in an untenable situation where bureaucracy was putting clinical research in difficulty by making it hard to manage for those already involved in it, and unattractive to young oncologists who are increasingly turning away from the field. With the ECRO Task Force, we are now trying to understand how to make the most out of the lessons learnt during these unprecedented times. I believe that we can use our experience with COVID-19 to adapt some of our research procedures, to prioritise them to reduce unnecessary administrative bulk and spend more time on the essence of our work: the clinic. But we cannot change anything by ourselves. My hope is that in the aftermath of this pandemic, we will be able to bring all stakeholders to the table – clinical researchers, academic groups, organisations , regulatory bodies, CROs, pharmaceutical companies – to try to resolve this problem in clinical research and use insights from these last few months as a basis for discussion. COVID-19 will not change everything, but it could help to drive progress on this issue.

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