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International Clinical Trials

Raising the Bar


As the clinical research environment grows increasingly time-pressured and complex, there is a need for consistent standards in training to ensure clinical research professionals are taught effectively.

There is a well-known mantra in clinical research which goes something like this: “If it is not documented, it didn’t happen.” We all document the training we receive, but what are we recording? What really happened in that training session? Were we sitting passively while the trainer went through the motions and showed countless overheads? Box ticked, backs covered, training record updated, a day wasted and a regulatory inspector fooled into thinking we might have learnt something.

In the clinical research sector we are obsessed with the documentation of training. The piece of paper that says we attended a course is not a meaningful output. If we deceive ourselves that it is, we leave ourselves open to tolerating poor quality training delivered by people who may not be sufficiently knowledgeable either in the subject matter or in training techniques.

I once worked with a company where the quality assurance department had written three separate standard operating procedures (SOPs) on training. Two of the SOPs dealt with the documentation of records, while the third concerned itself with training only in the context of attending courses. Consequently, the emphasis was on the documentation of training course attendance and not on whether people had learnt anything meaningful in terms of skills and knowledge.

Don’t Forget to Check the Output

Sometimes, when participating in audits, I have been asked by an auditor to look at the training materials to check the wordage used in overheads (if present) for accuracy and completeness; in other words, the input. Of course accuracy is vital, but this exercise in checking what may be only a minor part of the learning input is missing the key element: the output.

Let me give you another real-life example of where the objective was focused on the documentation rather than the imparting of knowledge. In 1991, Lynöe et al published the results of a survey which they conducted on patients that had participated in a multicentre clinical research study in Sweden (1). After the study, the subjects were asked to complete a survey testing their knowledge of the information that they had received as part of the informed consent process. Nearly 40 per cent of the subjects that responded were unaware that they could withdraw voluntarily from the study at any time despite all of them signing and dating the consent form that explained this concept. Lynöe et al concluded that there was a problem in the way that the patients had been given information and consequently in what they had learnt about the study. The perfect documentation hid a very fl awed process.

Unnecessary Delivery = Devaluation

Training can not only be of poor quality; sometimes it is delivered unnecessarily. Many organisations provide compulsory basic good clinical practice (GCP) training for all new employees, irrespective of their previous experience in clinical research. The same is true of some sponsors and their attitude to training investigator sites on GCP. This redundancy in training leads to its devaluation, particularly from the perspective of people who are made to attend training courses that will add nothing to their knowledge or skills.

What is Actually Being Learnt?

Sometimes the method of delivery is not appropriate. Some organisations have become over-reliant on e-learning, which is seen as a quick and relatively inexpensive option. This is true and like any learning activity, it can be very effective if used in the right way. However, it also has its limitations. It is easy to deceive ourselves that just because people are taking e-learning courses and printing out certificates, gained by passing a multiple choice test, that they are capable of meeting the standards of their job role, GCP and local regulations. After all, how many of us have learnt to drive a car safely using only e-learning as a method of training?

Too Much, Too Soon

There is often a misunderstanding in the clinical research sector about how training can be used to best effect in terms of the timing. I once worked with a line manager who had just recruited new staff members with no previous clinical research experience, with the aim of training them to be clinical research assistants (CRAs). As always there was pressure to get them up and running as quickly as possible. Their manager insisted that they attend the company’s very comprehensive four-day monitor training course in their first week of employment. The course was excellent and very interactive, with plenty of realistic case studies, exercises and examples. Despite everyone’s worst fears, the manager not only insisted the training was carried out in the new hires’ first week, but sent them out monitoring in week two. Unsurprisingly, these unfortunate people were not able to fulfil their job roles and their confidence was badly undermined. As well as the bad timing of the training, there was no assessment of competence to gauge whether or not the new CRAs were capable of performing to the required standards on the job.

Proof of Competence to Train

Another concern is that anyone, irrespective of their experience in both clinical research and training, can set themselves up as a business and deliver training without any regard to quality standards or any type of certification. It is always worthwhile drawing parallels with other industries. In various sectors of the plumbing, information technology and motor industries, for example, it is necessary to have some kind of independent, recognised certification that qualifies a person to carry out particular tasks so that there can be confidence that the work is being conducted to the relevant quality standards.

How Have We Arrived at This Point?

The ICH GCP Guidelines state that one of the 13 principles of GCP is that “each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s)”. Despite this being a fundamental principle of GCP, the guidelines mention the word ‘training’ a mere four more times in 52 pages. The word ’knowledge’ features once, while ‘learning’ and ‘skills’ do not appear at all. Other regulations are similarly devoid of information. Rather like the Sherlock Holmes’ case of the dog that did not bark, the clue to the mystery is not what is present, but what is absent. The primary focus of GCP guidelines and regulations is on the protection of the rights and well-being of clinical research subjects and the integrity and accuracy of data. To some extent, auditors and inspectors check the competence of people conducting trials through interviews and reviewing compliance with GCP guidelines, local laws and SOPs. Nevertheless it is surprising how little attention is paid to the quality of staff training, and particularly to learning and competence.

There is a need for consistent standards in training to ensure that clinical research professionals are trained effectively and efficiently in the increasingly time-pressured and complex environment of clinical research. Both the EMA and the FDA are taking a more measured and considered risk-based approach to quality management and monitoring. A similar philosophy should be adopted for training so that it is targeted, effective and adds real value. How can we raise standards in this crucial area? The following criteria should be met:

  • Ensure the trainer is competent. The person or people conducting or facilitating the training should be competent in training practice and learning theory. This means that they should be able to choose and use the right combination of learning methods. The trainer also needs to be knowledgeable about their subject matter.
  • Ensure the learning outcomes are clearly defined and measurable. The learning outcomes of each session should be clearly defined. This enables both learners and managers to agree on the most suitable learning activity to fill a skills and/or knowledge gap. Each learning outcome should have a method of measuring whether or not the outcome has been achieved. This involves collecting evidence either during or after the learning activity. The evidence should be relevant to the learning outcome. If, for instance, a learning outcome was to be able to write a monitoring visit report, then a report of adequate standard written by the learner should be the evidence collected. Evidence can often be collected back in the workplace post-learning.
  • Ensure there is robust assessment of the learning outcomes. Once the learning evidence has been collected, there should be a robust assessment by a competent person. This may be the learner’s manager or perhaps the person who delivered the learning session. Learners who do not achieve the required standard should receive further support and remedial training until they are skilled enough to fulfil their role.

Conclusion

As the clinical research sector becomes ever more global, we need an intelligent approach to learning. I believe we need international standards in good clinical training practice (GCTP). Appropriately trained clinical researchers can have a positive impact on subject safety, data integrity and the speed and efficiency with which trials are conducted. A set of standards for training will help to ensure that clinical researchers are properly trained in the ethical and scientific conduct of clinical research and that ignorance is no excuse for repeated errors, misconduct and fraud. The purpose of GCTP should be to ensure that learning is carried out effectively, efficiently and without redundancy. Only then can clinical research professionals, regulators and patients alike have confidence that the people who are involved in the conduct of clinical trials are truly qualified by education, training and experience.

Reference

  1. Lynöe N, Sandlund M, Dahlqvist G and Jacobsson L, Informed consent: study of quality of information given to participants in a clinical trial, BMJ 14: (303): pp610-613, 1991

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Martin Robinson is Principal Director of the International Academy of Clinical Research (IAoCR), where he leads a team providing independently accredited training courses for clinical research professionals, including project management, CRA and GCP training. Martin has over 15 years of international experience in training and education in clinical research. Martin’s CV includes work in organisational development for Dovetail and in training and development for the Institute of Clinical Research. He has also worked for Covance where he had a number of roles in training and development and project management.
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