As health workers we do all kinds of jobs and many of us don’t know what the other one is actually doing. This is a problem in at least two senses. Firstly, our struggles for better conditions for ourselves and our patients often remain divided into professional groups, trusts or departments. We therefore feature reports about health workers talking about their work, e.g. these reports by an NHS IT worker, by a community midwife or by a trainer for international nurses. Secondly, in the current system industries are structured in the interest of those in power and according to the rules of markets and money relations. That turns them into often fragmented and hierarchical systems that are not very conducive for a free and effective cooperation of everyone involved. As health workers, we therefore have to start understanding how our industry actually works in order to be able to take it over and run it in the interest of everyone in the future. We have to understand various aspects, from the supply of material, to research and production of pharmaceuticals or medical machinery, to the wider management of hospitals and services. We published articles on the structure of the pharmaceutical industry before. Below you can find a report of a friend who works as a research nurse in clinical trials, which are often sponsored by the pharma industry.
A lesser-known part of the work of both Trusts is the area of medical research. There are research studies going on in most specialities within the Trusts, and clinical research involves large numbers of staff- medical, nursing and administrative- as well as needing input from other departments such as pharmacy, laboratories, physiotherapy, radiology, etc.
I have been employed as a clinical research nurse for some years now. Broadly, research teams consist of nurses, health care support workers and study co-ordinators- non-medically qualified staff who oversee the running of trials, maintaining medical records and study paperwork, liaising with sponsors, etc. Nurses and HCSWs are involved in the day-to-day care of patients taking part in various trials- ensuring that the correct doses of study medications are given, that appropriate investigations and observations are carried out, and that any “adverse events” are reported and acted on appropriately.
Research trials worldwide are governed by a code of conduct known as the Declaration of Helsinki, which enshrines “Good Clinical Practice” principles to ensure that patients (or parents/legal guardians in the case of children) have given informed consent to join/continue in the study, that their interests are paramount, and that the study is conducted in accordance with ethical principles. From the British Medical Journal:
“The declaration was first adopted in 1964 in response to historical abuses committed under the guise of scientific research during the Nazi era and later scandals such as thalidomide. Developed by the World Medical Association (WMA) it sets out 37 ethical principles for medical research involving human participants.” (BMJ 2024, 387.q2357.)
Clearly this is not a principle that any reasonable person could object to (although one wonders how rigidly the Declaration is adhered to in, say, Russia or China.) However in practice it can lead to absurd levels of over-regulation, with “monitors” from the pharma companies who sponsor the research scrutinising the record-keeping, and insisting on correction of the most minor of discrepancies (e.g. the nurse may have recorded that an ECG was performed at 11.00 whilst the print-out on the machine reads 11.02- this gives rise to a “data query” whereby the data must be amended to reconcile the two times.)
Research studies can broadly be divided into “commercial” or “non-commercial”- the former generally being a pharma company trialling a new drug, or an existing drug for a new condition, or a drug known to be safe for adults in children or teenagers. In general this aspect of commercial research focuses on children with rare or incurable conditions such as cystic fibrosis, muscular dystrophy, or rare forms of epilepsy where there are currently few effective treatments.
“Non-commercial” studies are generally run by Universities and often do not involve medications- e.g. a study a few years ago that looked into whether inflammatory bowel diseases could be diagnosed from stool samples rather than invasive endoscopies. Both commercial and non-commercial studies will be overseen nationally or internationally by a Chief Investigator (CI), usually a Consultant specialising in the area which the study is investigating. Each participating hospital or site will then have a Principal Investigator (PI)- again, usually a Consultant although some studies may be overseen by other disciplines such as nurses or dieticians.
We receive proposals for trials and then have to decide if they are feasible. I estimate that only 20% of all trial proposals are actually accepted. Vaccine trials tend to be undertaken by the bigger pharmaceutical corporations, while smaller companies tend to focus on new treatments for the rarer conditions mentioned earlier.
There will then be a team of nurses, HCSWs and Study Co-ordinators assigned to the study. These all have to sign a “Delegation Log” to show that they have been adequately trained to deliver the study. The Delegation Log contains a list of tasks within the study, e.g. blood sampling, administration of the study medication, maintaining the site files (study records), etc.- each member of staff will sign against the list of tasks they will undertake (which vary according to their role), and the PI then signs to confirm that they are trained and able to perform these roles. The PI also signs to say they accept responsibility for ensuring that the study is delivered correctly at their site (according to a protocol provided by the sponsor- this can vary in length and complexity depending on the nature and duration of the study.)
The commercial studies are generally more complex, and generate income for the Trusts – some departmental funding may also depend on taking part in trials. As I said earlier, they are overseen by company monitors, who visit each site regularly to ensure compliance with the protocol. My understanding is that these people are generally much better remunerated than those of us who actually work on delivering the studies. But I have no real complaints- overall it is a rewarding job, with the knowledge that one might be helping to improve patient outcomes, whether for those involved in the study now or for future patients with the same condition. Of course, pharma companies are in competition with each other, with each hoping that “their” drug will be the one preferred by the NHS or other countries’ health-care systems. In a sanely ordered society, such knowledge would be shared for the benefit of all rather than being governed by competition.
From my personal experience in nursing over the last 30 years, and more recently specifically in nursing, I have observed a few breakthroughs when it comes to new medication, for example for cystic fibrosis. People are now living much longer now with that condition. The non-commercial studies, whilst subject to the same regulatory procedures, tend not to be so intensively monitored- perhaps because Universities tend not to have the resources to employ expensive monitors? Monitoring is often done by phone, or remotely (incidentally, during the pandemic when we could not have external visitors, all monitoring had to be done remotely – this was far from an easy task given the amount of paperwork/computer records involved), or left until the end of the study.
We sometimes receive immediate feedback on the results of the trials, which are then generally published in journals such as the Lancet or the British Medical Journal. These are published by the doctors who run the trial. While career advancement might be an additional motivation for some doctors to take part in trials, I do think their main concern is the well-being of their patients.
We sometimes get invited to take part in conferences or meetings abroad relating to the trials, sponsored by the companies running them. Up to 100 people take part in these international conferences. Whilst the content often adds little to what is already written in the protocol, it is interesting to meet other clinicians and compare experiences.
This article has of necessity been very general in nature, for reasons of confidentiality, but I hope it has given some insight into the nature of research within the Trusts. And one can also hope that one day medical knowledge will be seen as the shared birthright of all humanity rather than the subject of rivalry between competing companies. Unfortunately, as long as capitalism persists (even in allegedly “socialist” countries like China and Cuba), this will not happen
