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Standard of Care

In November 2010, a public inquiry opened to investigate the standards of patient care at Stafford Hospital in the UK. The inquiry was prompted by the number of avoidable patient deaths at the hospital. Statistics at the time showed there were between 400 and 1,200 more deaths than would be expected. Inquiry chairman Robert Francis QC described the “terrible standard of service inflicted on so many of the patients who went to Stafford Hospital and their families.”

The inquiry ended after 139 days, at a cost of over £10 million, and a final report, published in February 2013, said that the failings created a culture where the patient was not put first. Cost-cutting and target-chasing had become a priority, rather than the needs of the patients. The situation had become so serious that the police were involved and investigated the cases of over 300 patients whose deaths could have been caused by neglect. Some of the specific findings included nurses failing to read patients’ notes; patients’ notes being incorrectly completed; blood tests not being taken; patients not being given adequate pain relief; and food and drink being left out of their reach. In response to the inquiry, the British Government announced a number of changes to improve patient care, including a revision of the way that nurses are assessed and trained.

Fit for Practice

Currently in the UK, it is the responsibility of nurses to declare themselves fit to practise, a process known as renewal. The reaction to the inquiry from the Nursing and Midwifery Council was to propose a system of performance evaluation for nurses that uses assessments from patients, colleagues and employers. The Director of the UK’s Royal College of Nursing, Tom Sandford, identified that verifying competence was the way forward when he stated: “Knowing that every nurse, no matter when they qualified, is fit to practise in a modern setting, and competent for the role they are performing, is an important issue of patient safety, as well as patient confidence.”

The scandal at Stafford Hospital was related to general medical care. It took disastrous failings in the system to produce a response that included the verification of competence for nursing staff. What can the clinical research community learn from this? How can we prevent such a disaster happening in the field of clinical research, where arguably the demands required by experimental treatments are even more rigorous than in ‘normal’ medical care?

Regulatory Background

The history of clinical research is a chequered one. The evolution of Good Clinical Practice (GCP) has often followed a pattern of reaction to unintentional disasters or deliberate misconduct. The Nuremberg Code, the forerunner of the Declaration of Helsinki, was drawn up in 1946 as a result of the horrific findings at the trial of several Nazi physicians who had performed barbaric experiments on human subjects with no regard to their rights or wellbeing. Large numbers of prisoners were forced to take part in medical experiments which often resulted in them suffering severe pain, disfigurement, disability and, frequently, death. The Nuremberg Code specified 10 key principles under which medical research must be carried out.

The thalidomide tragedy in the early 1960s resulted in the passing of the Kefauver-Harris Drug Amendments Act in the US in 1962. Legislators tightened restrictions surrounding the surveillance and approval process for drugs to be sold in the US, requiring manufacturers to prove that new treatments are both safe and effective before they are marketed.

The Investigational New Drug process was also introduced in 1962 which required that all new drug research had to be approved by the FDA before it could commence. Equivalent legislation soon followed in Europe.

Harmonisation of GCP started in 1991 with the introduction of the European GCP Guidelines, and then, in 1997, the ICH GCP Guidelines were finalised between the regulatory bodies of the EU, Japan and the US.

The various regulations and guidelines have the protection of the rights and wellbeing of human research subjects at their core. This philosophy has come to permeate medical research because of what has happened when this central concept is disregarded or neglected. One of the other principles of the ICH GCP Guidelines states that: “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” However, there is no mention of competence or how people who work in clinical research have their performance assessed, or how regularly that should occur.

Need for Competence

Given that lack of competence appeared to be one of the contributory factors in the poor standards of care at Stafford Hospital, there could be the potential for similar problems in clinical research. The running of a trial relies on contributions from a wide range of specialists and professionals who are inter-reliant on each other in terms of designing, conducting and verifying all the activities of a clinical trial. Every one of these people must be competent in their respective roles to ensure that trials are run to the required ethical and scientific standards, and that regulations are followed and patients are protected.

Of the major regulations and guidelines, only the Declaration of Helsinki refers to the concept of competence. Clause 16 in the section on Principles for All Medical Research states: “Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.” Ironically, many sponsors require that their investigators sign a statement agreeing to comply with the Declaration, yet there is no standardised method of verifying an investigator’s competence.

None of the guidelines or regulations mention the competence of any of the other roles in clinical research. There is no room for complacency – as the evidence suggests, there is plenty of scope for improvement in performance standards in clinical research.

Critical Findings

According to the UK’s regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), in its latest report, GCP Inspection Metrics 1st April 2009 - 31st March 2010 (Version 04/03/13), 81.3% of commercial sponsors inspected had at least one major and/ or critical finding. For non-commercial sponsors, the figure was even higher at 96.4% and over a fifth had at least one critical finding. A critical finding is defined as being when the safety or wellbeing of trial subjects either has been or has significant potential to be jeopardised, and/or the clinical trial data are unreliable. The most common types of finding in the non-commercial sector were investigational medicinal product management, pharmacovigilance and organisational oversight. These are worrying trends as shortcomings in all of these activities can have a potentially serious impact on patient wellbeing.

On a wider scale, data from the EMA’s Annual Report of the Good Clinical Practice Inspectors Working Group 2012 is equally disturbing. During that year, the EMA surveyed inspection information from their EudraCT database. This database contains key information about all clinical trials of investigational medicinal products with at least one site in the EU. The EMA collected data from 366 inspections worldwide, mostly at investigator sites, and discovered that nearly 70% of the organisations had at least one critical or major finding.

Neither the MHRA nor EMA reports comment on what the solutions may be to improving standards within clinical research. However, the data from both reports indicate that there is significant potential for endangering subject wellbeing and data integrity.

An argument can be made that anyone with a role in the conduct of a clinical trial can have a significant impact on subject safety and data integrity. The two key individual roles described in the ICH GCP Guidelines are that of the investigator and the monitor. One of the outcomes of the Stafford Hospital inquiry is to have performance assessments for nurses. At the moment, there is no such specific requirement for investigators or monitors, and no method of competence verification.

Future Steps

The creation of a set of performance standards for both of these roles would be a good first step. Such a set of standards is a competency framework which sets out the skills, knowledge and behaviours that are needed to perform effectively. These frameworks can be designed based on the roles and responsibilities of investigators and monitors described in sections 4 and 5.18, respectively, of the ICH GCP Guidelines.

There has to be a balance between introducing new requirements and creating extra bureaucracy. Unnecessary red tape is a distraction from the protection of clinical research subjects. Any competency frameworks would have to be comprehensive, yet concise and practical, so that they could be used globally for any type of trial. The potential benefit of having the ability to verify competence is better conducted trials with reduced risks to patients, and less time and effort in having to correct errors or deficiencies.

Another advantage of assessing competence, rather than counting years of experience, is to be able to target training precisely when and where it is needed. Having a competence-based system would allow individual training needs to be identified and avoid the need for the haphazard, box-ticking approach to GCP training which is currently in vogue. Investigators in particular find it very frustrating to attend repetitive GCP training each time they commence a study with a new sponsor. This approach is often used as a means of ensuring that training has been documented, rather than ensuring competence in GCP compliance.

This is a great opportunity for the clinical research community to be proactive in preventing any threat to patients or data by taking this step and introducing a need for competence verification for clinical researchers. This will increase public confidence in research, and contribute towards raising standards and protecting patients wherever research is carried out globally.

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About the author

Martin Robinson, PhD, is Principal Director of the International Academy of Clinical Research. He leads a team providing independently accredited training courses for clinical research professionals, including project management, clinical research associate and GCP training. Martin has over 15 years of international experience in training and education in clinical research. His past career highlights include working in organisational development for Dovetail, and in training and development for the Institute of Clinical Research and Covance.
Martin Robinson
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