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International Clinical Trials

Live and Learn

Clinical research professionals – whether it be investigators, site staff or sponsor employees – all have a responsibility to protect the rights and well-being of trial subjects. Decisions are made about patients on a daily basis to ensure that no subject’s rights are infringed and that the care benefi ts they receive during the clinical trial justify the risks.

In many other industries where health and safety is an issue, people working in those sectors are certifi ed or accredited to conduct specifi c jobs. Professions as diverse as forklift truck driving and psychology, for instance, have independent and accredited training schemes and standards in place. So where does clinical research sit, and does it need to catch up?

Industry Competence

Clinical research guidelines, such as the ICH Guideline for Good Clinical Practice E6(R1), make very general references to training. “Each individual involved in conducting a trial should be qualifi ed by education, training and experience to perform his or her respective task(s),” states the document’s Principle 2.8. However, there is currently no set of standards in clinical research for how individuals are trained and assessed to ensure they are working to the required performance standards.

Most people working in our industry are highly qualified – degrees in medicine or biological science, or a nursing qualifi cation are the norm. Yet none of these qualifications are related specifically to conducting clinical trials competently. The ICH guidelines mention qualifications according to education, training and experience, which are all learning inputs. Nowhere is there a mention of the key output – competence.

Having internationally recognised and accredited professionals whose competence has been independently assessed would give both the industry and the general public further reassurance that those in clinical research are competent to fulfil their roles.

Current Practices

A search on the internet will reveal many clinical research training suppliers, ranging from freelancers and individual consultants, through to commercial and non-commercial organisations such as training companies or not-for-profit membership organisations. Currently, there is no set of standards to verify which of these organisations or individuals are credible or proficient to deliver training effectively and impart competence to the learners.

Clinical trial sponsors, both commercial and noncommercial, provide training not only to their employees but also to investigators and site support staff. Depending on the organisation and its size, training might be coordinated and provided by an internal team of trainers. Alternatively, some organisations may outsource all or some of their training.

One of the consequences of a lack of standards is that training by one organisation is often not recognised by another, particularly with respect to good clinical practice (GCP) training. The result is unnecessary repetition of training of both sponsor and investigator site staff. This devalues training in the eyes of the learners if they feel they are wasting a day covering material with which they are already familiar.

Meetings with senior managers from all sectors of clinical research, carried out by the International Academy of Clinical Research, revealed a well-meaning but unfocused and disjointed approach to training. The conclusion was that some set of recognised standards of accreditation was the way forward in order to bring clinical research in line with other sectors where people’s safety is at stake.

Training Limits

Clearly, people can acquire knowledge, gain new skills and adopt appropriate behaviours by attending a training course or seminar. However, this is not guaranteed – a certificate of attendance testifi es only that a person was in the room at the time the training took place. Some courses require attendees to complete a knowledge test. This at least gives a certain assurance that the attendee has acquired some knowledge.

What is missing is whether or not the learner has the ability to apply the knowledge appropriately using the relevant skills and behaviours. It is akin to giving someone a driving licence based solely on their ability to pass a theory test on how to drive a car and recognise road signs, with no practical test of skill.

Edges of Experience

Experience does not guarantee competence either. Many employers require that new hires or contractors need a minimum of two years’ clinical research experience. However, the quality of this experience can be variable, and there is no guarantee that the time was spent working to adequate performance standards or that the breadth and depth of experience was sufficient.

In one example, a company hired a contractor research associate (CRA) with 10 years’ experience. After a few weeks it became clear that the standards to which this person was used to working were significantly below what their new position required. Despite some retraining, the old habits were so ingrained that they continued to underperform and soon afterwards the contract was terminated.

A scan of job vacancies reveals that many organisations demand previous experience. Many new graduates in biological sciences complain that they cannot find work in clinical research because they lack work experience – resulting in a shortage of new talent entering the sector.

From the industry’s perspective, the situation is not much better as organisations are constantly playing catch-up in trying to acquire enough experienced and skilled people to meet their resource demands. Ironically, the time-pressured environment of clinical research and the shortage of experienced staff can lead to a reluctance by companies to invest time and money in training new graduates, as the need is for people who can ‘hit the ground running’ with little or no extra training.

Proposed Framework

To apply rigorous standards to the training of clinical research professionals, one of the solutions is to have a system of internationally recognised accreditation.

At present, some organisations claim to be accredited, while others maintain that specific training courses have received accreditation. This accreditation may involve a general stamp of approval that the organisation and its learning materials are credible.

This is better than nothing, but for accreditation to be meaningful there must be a focus on the outcomes of the learning activity. The outcome of a training course should be that the learners gain competence – defined as an observable demonstration of knowledge, skills and behaviours (this includes having the appropriate attitude).

An accreditation scheme designed to deliver verifiable competence should have three components:

1. An independent assessment of the ability of an organisation or individual to deliver or facilitate the learning event successfully. The training organisation must have the relevant policies and procedures in place which, when followed, assure the quality of the training. Those individuals running the learning activity must have the skills to facilitate it, as well as the subject-matter knowledge. The learning activity should take place in a suitable physical or virtual environment which is conducive to learning and free from distractions.

2. Each learning activity must have well-defined learning outcomes. These must be articulated in such a way that they clearly describe what competence the learner will gain in terms of knowledge, skills or behaviours. The outcomes should be capable of being assessed and measured using criteria which demonstrate that the learning outcome has been achieved. There should be an independent review of the learning outcomes, their respective assessment criteria and the methods for collecting learning evidence to check their clarity and relevance.

3. Once the learning activity has taken place and the learning evidence collected, there should be an independent assessment that the learners have achieved the desired outcomes and can demonstrate the required level of competence. The independent assessor should review the evidence and whether or not it suitably demonstrates the achievement of the learning outcome. If the assessor is satisfied the evidence demonstrates competence, the learner is awarded a certificate of accreditation.

Practical Issues

Accredited courses with defined learning outcomes can be developed for key job roles within the clinical research sector, such as monitors, data managers, drug safety associates and investigators. This would enable individuals to gain accreditations in these disciplines and so have a certification of competence for employers.

However, it is not practical to accredit all training courses in clinical research. Study-specific training falls into this category as the learning outcomes are relevant only to the procedures and processes unique to that study. Organisational-specific areas – for instance, training in standard operating procedures, updates to new developments in GCP, or regulatory updates – do not lend themselves easily to accreditation. Nevertheless, all learning interventions should be properly designed and have specifi c learning outcomes as if they were accredited.

Global Benefits

Clinical research is a global industry, with many intercontinental trials and multinational project teams. In this environment, internationally recognised accreditations for clinical research professionals would help provide a more mobile and flexible workforce. It would give employers confidence when hiring or contracting staff and give individuals the ability to explain and demonstrate evidence of their competence to potential employers.

It would also enable a much better match between supply and demand globally. Sponsors would benefit from having confi dence and reassurance when hiring contract research organisations (CROs) with accredited staff, and CROs could demonstrate the potential of their capabilities on a sound footing by having accredited people.

At the same time, collaboration between industry and universities could see the development of accredited work placements for students, helping to solve the problem of getting new talent into the industry.

The benefit for clinical research as a whole would be better qualifi ed and more competent people who are able to conduct clinical trials quicker and more effi ciently and intelligently by reducing costs and delays due to poor study design, excessive data queries, protocol violations and regulatory non-compliance.

These moves would help to protect the rights, safety and well-being of trial subjects, as well as to verify data integrity. The result would be a positive impact on public confidence in clinical research and, ultimately, a reduction in the time and cost it takes to make new treatments available for patients.

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Martin RobinsonPhD is Principal Director of the International Academy of Clinical Research, where he leads a team providing independently accredited training courses for clinical research professionals, including project management, CRA and GCP training. He has over 15 years’ international experience in training and education in clinical research.
Martin Robinson
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