Pharmalys Ltd launches
for young scientific graduates
Clinical research becomes more and more complex
Clinical research (CR) study protocols are getting longer and more complicated, with more sophisticated operations and visit-related assessments. Phase II and III studies may include over 250 procedures per participant and close to 20 endpoints. As research aims to address unmet needs across numerous acute, chronic, and rare disease groups, study populations are likewise becoming more complicated.
Numerous papers cite investigator-initiated clinical studies (IITs) as an illustration of the complexity and challenges that clinical research professionals (CRPs) and organisations must deal with. They are essential to producing trustworthy evidence that responds to issues in daily clinical practice, but they are a hard venture due to numerous obstacles. For example, they frequently need to be international in order to attract an adequate number of patients; as an added challenge, recent studies have highlighted the need for well-trained and experienced study personnel who are a crucial factor in carrying out such complicated IITs successfully.
The demand for qualified clinical research professionals significantly increases
Larger trials involving more patients necessitate more skilled CRPs to perform and oversee clinical studies properly. The WHO anticipates that by 2030, there will be a shortage of 10 million health workers, primarily in low- and lower-middle income countries.
To varied degrees, countries at all socioeconomic levels encounter challenges with regard to the training, employment, deployment, retention, and performance of their workforce. The persistent underinvestment in health worker education and training in some nations as well as the misalignment of education and employment policies with regard to health systems and population demands are factors in the ongoing shortages.
Clinical research professional staffing was impacted significantly by COVID-19. Pre-pandemic shortages in academic medical centres were estimated to be at 15%; during the pandemic, they increased to 29%.
Staffing issues may cause research activities to be delayed or stopped, negatively affect compliance and research quality, jeopardise patient safety, or increase worker unhappiness, which in turn results in additional staff turnover in a vicious cycle.
In Contract Research Organisations (CROs), which are currently the main employers in this industry, the staff shortage has been acknowledged as one of the key causes for a high turnover rate.
It proves very challenging to hire new staff. Clinical research newcomers sometimes struggle to secure their first employment, citing barriers like the demand for prior CR experience in many job listings. On the other hand, a lot of CROs hire and educate novices who stay with the company for one or two years before moving on to work as a qualified and experienced CRP, which results in a steady supply of junior employees.
To address clinical research staff shortages, training and education are key
Employers consistently discuss the challenges they have finding and keeping CRPs with the necessary qualifications. One of the biggest obstacles is a shortage of qualified study personnel.
The importance of education and training in enhancing the quality, success, and efficiency of clinical research in general has been emphasised and supported by numerous well recognized publications. Training and education are crucial steps for enhancing the influence of clinical research findings on medical therapy, according to the Lancet series “Research: increasing value, reducing waste”. According to the Organisation for Economic Co-operation and Development, one of the most important factors in ensuring the success of clinical research is supporting and facilitating the infrastructure, education, and training needed for academic clinical trials.
Being aware of this issue, Pharmalys (Home (pharmalys.com) decided to launch PACE (Pharmalys Academy of Clinical research Excellence)( PACE | Pharmalys Academy of Clinical research Excellence (pace-cr.com), which aims at providing job-ready CRPs. Graduates in life or social science, or any health related topic are eligible as well as healthcare professionals, as well as graduates and professionals from technical fields such as biostatistics.
PACE 9-month programme encompasses 3 months of academic interactive, live online training focused on experience-sharing and practical exercises; followed by a 6-month internship in a company that is experienced in conducting clinical trials (PACE: live the learning experience | PACE (pace-cr.com). We think that a 9-month course is the minimum required to appropriately train new comers in clinical research.
References:
- Knapke JM et al. Journal of Clinical and Translational Science 6: e80, 1–9. doi: 10.1017/cts.2022.411
- Magnin et al. Trials (2019) 20:616 – https://doi.org/10.1186/s13063-019-3702-z
- Toto et al. Trials (2020) 21:680 – https://doi.org/10.1186/s13063-020-04620-8