Recent Announcement Reveals Supply Chain Risk to Clinical Trials & Patients

March 07, 2023

Accreditation isn’t expensive, the cost of ICH-GCP violations is!

Could the Pfizer / Valneva issue happen to your trial?

In 2021 the FDA reported:

  • 36% of all clinical trials fail
  • 51% of clinical trials fail to follow the investigational plan

Considering these statistics, the situation that Pfizer and Valneva recently found themselves in is disturbing, but not surprising.  According to Valneva’s website “The study is investigating the efficacy, safety, and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.”

Verifying that the clinical trials workforce have understood, and are capable of working to ICH-GCP is not currently conventional in the clinical research industry.  Violations of ICH-GCP happen every day, and until sponsors improve their vendor risk assessment processes to ensure suppliers are competent, contraventions will continue to be widespread.

Cost of Risk Endemic in the Supply Chain

Selecting staff and outsourcing partners that you trust to recruit patients and run clinical trials is essential to the clinical research ecosystem.  However, with outsourcing comes a change in risk profile.  Companies audit their supply chains to mitigate risk, but usually omit to look at one very important issue: what evidence is there that the people working in their supply chain can perform their jobs competently?

As a whole, the clinical research industry performs very badly when it comes to mitigating risk through competence verification and adherence to professional standards.  The general consensus around ICH-GCP is, that if someone attends a training course and (maybe) completes an online multiple choice questionnaire that they’ve complied with the Regulations and they’re good to go.  This thinking is lagging behind that of other industries, where Professional Accreditation is a mandatory requirement in order to operate. The current approach in the clinical research industry allows risks to go undetected throughout the supply chain, until something goes wrong.

The reason why other industries insist on evidence-based professional accreditation, is because it makes complete financial sense. It :

  • Reduces risk in the supply chain
  • Reduces costs associated with poor quality, re-work and delays
  • Assists in attracting and retaining staff and enables targeted training
  • Reduces risk to reputations, and helps maintain client confidence.

In addition to these general benefits, professional accreditation within the clinical research industry specifically would reduce risk to patient safety and data integrity.  Therefore, everyone working in the clinical trial supply chain should be looking at how they can improve quality through assurance of competence and compliance with global professional standards.

Are Regulators to Blame?

Clinical trials are highly regulated, but unlike other regulated industries, workforce regulations are flimsy.  Anyone can setup a clinical research company and anyone can work in clinical research, providing they’re “qualified” through education, training and experience. Generally, this means checking someone’s documented experience and, in some circumstances, conducting an interview.  Generally, the focus is on CVs or resumes and training records – not on evidence that a person is a competent professional.

The consequences of CV or resume fraud in clinical research are also significant – they can potentially compromise the safety and efficacy of clinical trials and this risk shouldn’t be underestimated.  There are numerous studies pointing at pervasive CV and resume fraud in the clinical research industry, and a 2020 NIH National Library of Medicines manuscript on “Assessing Trustworthiness in Research: A Pilot Study on CV Verification” makes very sombre reading.  Suggesting that misrepresentations and fraud are as widespread in the academic sector as they are in the commercial sector.  The clear message here is that information provided in CVs and resumes cannot be trusted. Therefore, robust and efficient processes to assess competence must be embedded to mitigate risk.

Laudable efforts have been made through a global collaboration across the biopharmaceutical industry, resulting in the introduction of a mutual recognition program for ICH-GCP training.  Whilst this has saved time and money by reducing redundant training, costs continue to be incurred by the industry due to staff with unverified competence who, in some cases, are not following ICH-GCP and are not fit-for-purpose.  To truly reduce risk and costs, the focus needs to turn to ensuring professional standards are adopted and competence verification becomes the status quo.

Since launching in 2011, IAOCR continues to work with global bodies and industry leaders to develop Professional Accreditation Standards for the clinical research industry.  Regulators have collaborated on building IAOCR frameworks and standards and they have confirmed that competence verification and professional accreditation should be the industry norm.  However, some have raised concerns and acknowledged that they can only inspect from a clinical operations perspective and, while workforce procedures fall outside their scope, they acknowledge it is impossible to have quality outcomes and a low risk environment if the people working in the industry aren’t fit for purpose.

Cost -v- Benefit of Accreditation

ICH-GCP assessment and accreditation with IAOCR is cost-effective at just £60 / $73 US per person.  It provides a robust and cost-effective way of qualifying clinical research staff, without unnecessary training.  It provides reassurance of a competent supply chain and reduces risk to trials, patients and reputations.

Mapped to the International Standard Classification of Education developed by UNESCO, the IAOCR ICH-GCP Accreditation is internationally accepted.  Professionals achieving accreditation are awarded a distinct accreditation mark, Certificate of Accreditation, and unique professional identification number.

When embedded into a quality assurance process, gap analysis reports can be provided to enable targeted workforce development and support, and competence overview.

Individuals can register for assessment via the IAOCR website https://iaocr.com/get-accredited/accreditations-for-individuals/

OR – if you are an organisation looking to reduce risk to reduce risk in your workforce and supply chain please contact info@iaocr.com

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