Reducing Risk: Professionalising our Industry

Clinical research is the fastest growing industry in the world worth US$ 49.8 billion in 2022 which is estimated to reach a staggering US$ 84.43 billion by 2030 (ref. Global Newswire). And yet over the past five years the FDA has reported a failure rate of 36% in clinical trial site inspections. The reasons for the failures were detailed in the 2021 FDA Report:

  • Failure to follow the investigational plan (51%)

  • Protocol deviations

  • Inadequate record keeping

  • Inadequate accountability for investigational product

  • Inadequate subject protection (including informed consent issues)

It has been noted that after the pandemic, the demand for more trials and the subsequent urgent need for staff is a global issue, all whilst the global spotlight has moved onto clinical trials with an increased expectation from the public for professional competence. Given the decentralisation of clinical trials, there is a new complexity on trial protocols and the focus on regulations and guidelines required to manage clinical trial activity have increased.

Clinical Research is such a highly regulated industry but consistent global standards for providing training to ensure an appropriate level of qualification do not exist and are not even required, does this mean we are putting patient safety & data integrity at risk?

Key factors are impacting the professionalisation of our Industry:

  • 40% of Global Workforce considered leaving employer post the pandemic (Microsoft 2021)

  • Training does not offer the only solution = it needs to be competence based (Knowledge-Skills-Behaviour)

  • Employer Critical Risk Management Strategy: Confident in professionalism, capability & integrity of employees

But the solution is arguably very straight forward:

  • Call to change: More than ever focus on how do we attract and retain great talent

  • Competency based recruitment: Competency Verification-Standards-Frameworks

  • Lack of Harmonisation: Clinical research training cannot be an “add-on,” it needs to be recognised as a profession

  • Concept of SQEEP: Suitably qualified experienced and empowered people

  • Engaged, Motivated, Competent, Valued, Respected & Recognised: High performing

How do we achieve this?

IAOCR’s Workforce Quality Association (WQA)

The Clinical Research Workforce Quality Accreditation was developed in collaboration with industry experts in response to demand from CROs and pharmaceutical companies. Awarded at the organisational level, IAOCR Workforce Quality Accreditation provides independent internationally-recognised standards to varying levels:

Reasons for change is compelling, not making a change is even stronger

What are we doing to recruit and train staff to ensure competence at our clinical trial sites?

What is the impact of competency gaps on the patients, data and workforce?

Barriers: Time and Money: “We have always done it like this”

Change: Shift the mind-set: “Why are we not doing it?”

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