Future of clinical research development depends on so many important factors that collectively still need to be worked on. Clinical trial set-up processes have been continuously changing while lots of challenges remain to be unaddressed. Degree of variation and specification continues to be very high offering research professionals robust working platform with ongoing effort to cope with, on the account of stretched timelines, resources, and compromised quality outcome.
Number of different vendors tend to use their own company platform, which often offers unique set of specifications in their form of training, data capturing, staff record keeping, etc. These types of requirements are often imposed on their users who are asked promptly to address these. Each training offers independent password protected access, sometimes can even conflict with a network compatibility. During set-up and conduct, clinical research teams that run great size of studies portfolio are asked individually to address such sponsor specific requirements. In this rising fast paced global research market working platform is generating more convoluted routes to work on and to maintain. Although some trainings are often well structured and guided, collectively there are just far too many tasks to cope with and be comfortably followed while making the whole process rather overloaded on its complexity, cost, and stress level involvement. Despite of some ongoing improvements the whole working platform remains being robust and rather inefficient, often offers a space for an error while unnecessarily stretching the manpower demand. In commercial sectors these convoluted processes are generating more posts, which can be considered a positive factor in the light of a job market, but in the public sector it tends to be ongoing struggle since in overstretched teams often a one person is asked to handle more diverse type of tasks while expected to secure quality and quantity. This is particularly evident in the UK NHS services where working teams are often under-resourced and pushed to generate additional job roles with limited financial resources. Lots of research posts tend to have combined more type of research / protocol activities performed by one person in order to provide maximum coverage. National regulatory bodies although understand, established structure and form of compliance remain to be maintained and adhered as part of the GCP requirement, which is inevitable for a site to meet feasibility criteria taking a part in clinical research.
What can significantly help to facilitate those operational processes taking some burden away is working on some standardisation and streamlining. By implementing more standardised forms and procedures, adjusting appropriate guidelines within better form of transparency would encourage research stakeholders to avoid implementing company’s unique specifications, especially in the areas where are not needed and are unjustified. This would offer especially public sector research sites to work more efficiently and smoothly while still maintain the compliance. Such platform can also promote better form of collaboration especially on studies that could benefit from.
Operational processes are more and more paperless, digital format should remain in continuous focus for its further development offering more standardised, transparent and use friendly approaches while also improving compliance and environmental elements. These suggestive tools can assist authorities, stakeholders and participating sites to operate more smoothly, encouraging research professionals to concentrate on their research objectives while seeking important advancements and form of collaboration.
Author: Galina Petrikova
Galina has extensive experience in working in clinical research in the UK. She has prepared this blog post to discuss her views on the challenges in running clinical trials in the NHS and also to provide the site perspective of the issues, which is often overlooked.