Dr Martin Robinson, Executive Vice President and International Academy of Clinical Research (IAOCR) Ambassador, talks about patient safety as one of the central principles of clinical research
Clinical research professionals, whether they be investigators, site staff or sponsor employees, all have a responsibility to protect the rights and well-being of trial subjects. Decisions about patients, both individually and collectively, are made on a daily basis to ensure no subject’s rights are infringed and that the care they receive during any clinical trials is justifiable given the risks involved.1
Patient safety is a central principle of clinical research. In other work sectors where health and safety are at risk, some form of certification or accreditation is often required. The Gas Safe Register in the UK is a system for certification of gas engineers that verifies they are competent to work safely and legally on boilers, cookers, and other gas appliances. The International Institute of Business Analysis (IIBA) has a system of accreditation for business analysts. For the operation of pleasure craft, there is an International Certificate of Competence (ICC), which may be issued to anyone who has successfully completed certain national boating licenses.
Industry competence: Current training and practice
Clinical research guidelines, like the ICH Guideline for Good Clinical Practice (GCP) E6(R1), make very general references to training. “Each individual involved in conducting a trial should be qualified 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 competent and working to the required performance standards. The ultimate goal should be to have clinical trials conducted efficiently and effectively while protecting the rights and well-being of patients as well as the integrity of the data collected.
Regarding suppliers of clinical research training, there appears to be a somewhat unfocussed and disjointed approach. A simple search on the Internet reveals many clinical research training suppliers including freelancers and individual consultants. Currently, there is no set of standards to verify which of these are credible or proficient to deliver training effectively and impart competence to the learners.
In terms of the training by organisations of their own staff, it might be coordinated and provided by an internal team of trainers, depending on the organisation and its size. Alternatively, some companies 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 GCP training. This results in repetitive and unnecessary GCP training without any competence assessment of staff and is particularly prevalent in training investigators and their teams. The consequence is wasted effort on the part of both sponsor and investigator, which is an unsatisfying and demotivating experience for both the trainer and the training recipients.
Some progress has been made by TransCelerate which is a collaboration between biopharma companies to design and facilitate the implementation of solutions to drive efficiency and effectiveness in the development of new medicines. One of the TransCelerate initiatives concerns Site Qualification Training. This initiative is centred on minimum criteria for GCP training content that will enable member companies to mutually recognise one another’s training. The focus is on the content of the training rather than learning outcomes. While this is a welcome step, the initiative does not go far enough, focusing only on inputs rather than the all-important outputs – expressed as competence.
Using a competency-based approach
Competence can be defined as an observable demonstration of knowledge skills or behaviours. A competency framework is a management tool which is designed to help assess an individual performance objectively across all levels of the organisation2. These frameworks can be used to identify performance gaps and hence specific learning needs. This enables training to be targeted and avoids the ‘sheep dip’ approach where, for example, everyone is given annual GCP training without any regard to their actual learning needs.
Another crucial element is to ensure that any learning intervention (e.g. a training course) meets the required standards and, when delivered, has the potential to fill the competence gaps. Each learning intervention should have measurable learning outcomes. Having these learning outcomes independently recognised using some form of accreditation would make the system suitably robust. This would enable individuals to gain an accreditation/ certification providing they could prove that they demonstrated the level of competence required by the learning outcomes of the training course.
Delivering performance across geographies
Clinical research is a global industry, with many studies being not just international but intercontinental. Organisations need to be able to operate worldwide whilst still having local knowledge and expertise.3 Internationally recognised accreditations would provide a more flexible workforce, thereby ensuring a better match between supply and demand globally. It would also give confidence to employers when hiring or contracting staff and give individuals the ability to explain and demonstrate evidence of their competence to potential employers. Sponsors would benefit from having confidence and reassurance when hiring contract research organisations (CROs) whose staff were accredited, and CROs could demonstrate the potential of their capabilities by having accredited people.
Along side, developing and verifying competence allows new talent to be developed efficiently and effectively with the result that new intake of hires is fully and rapidly productive. It is vital that the clinical research sector has a steady stream of new talent to meet the demands and challenges of the future in the various developing geographical regions.
Summary
Having a systematic and robust system of competence-based accreditation has great potential in ensuring that individuals working in clinical research are competent. Each individual working in clinical research should have an obligation to develop themselves against performance standards and to gain recognition of competence wherever possible. The desired effect is to be able to conduct clinical trials quicker, more efficiently and with fewer errors. This represents a great opportunity for the clinical research sector to make a major step forward in developing a talented, flexible and global workforce that is equipped to meet the challenges of conducting top-quality clinical trials globally. This results not only in the potential positive impact on public confidence in clinical research but also helps to protect the rights, safety and well-being of trial subjects, as well as to verify data integrity.
References:
1. US Department of Health and Human Services. 2009. Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of
Study Subjects (Internet) http://www.fda.gov/downloads/Drugs/…/Guidances/UCM187772.pdf [Accessed 08/05/2015]
2. Peter Schueler, Brendan Buckley, 2014. Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process. Academic Press, London
3. Umakanta Sahoo, 2012. Clinical Research in Asia: Opportunities and Challenges. Woodhead Publishing, Cambridge
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