Clinical trials play a huge part in the development of a new drug, delivering key data on the performance, effectiveness and side effects of the medicine and determining its suitability for the market.
Digitalisation is a buzz word floating around a lot of industries right now and it’s particularly prevalent for clinical trial technology. This is because they are incredibly time-consuming, expensive and the data they produce is invaluable.
A study by Cambridge Consultants found that there are roughly 7,000 active phase III interventional trials in the U.S. and the cost of clinical trials in 2013 was estimated as $10 billion. [1] With such a huge investment in them, clinical trials should be looking at how they can carry out trials in a more efficient manner, securing their data and making things easier for participants.
Changing the way we view digital processes
One area that needs an adjustment is the way that the people using them are responding and reacting to digital systems. For example, Daniel W. Burgess, Chief Compliance Officer at Pharm-Olam calls for using a digital Quality Management System (QMS) to improve recognition of and to reward positive behaviour, reducing the use of the QMS to apply actions that could be perceived as punitive. He stresses that a process is there to make life easier for people while they are doing their jobs: “We use the systems to empower the individual to provide their best. I would like to see compliance systems enable the move from penalisation to encouragement and reward for positive compliance.”
This is a very pertinent point and may be where organisations are failing to get the real value from their QMS. After all, you can implement and validate a software system to be compliant, but if you don’t look at the behaviours surrounding the use of it, then you may be missing out on valuable preventative and control measures, as well as positive employee contribution.
This ties in with the move away from reactive Corrective Actions and Preventative Actions (CA/PA), instead moving towards risk-based thinking. While ‘risk-based thinking’ is a requirement of ISO 9001:2015 in terms of quality management, the real value in this shift is the way organisations approach it. This changes the view on corrective and preventative actions from a box-ticking exercise to something proactive which also looks for opportunities rather than negative outcomes.
Streamlining patient involvement
Patient adherence is one of the top issues in clinical trials, with patient dropouts affecting 85% of trials, leaving them with inconclusive results. In addition, the Clinical Trials Transformation Initiative (CCTI) has called for increasing the quality and efficiency of clinical trials over the past 10 years. The main logistical reasons for participants dropping out of studies include an inconvenient schedule or location of the study and being required to be physically present.
Having a digital alternative would not only make the process smoother and much less time consuming, but participants might be less likely to drop out of a clinical trial, resulting in better quality data and results. In addition, the Cambridge Consultants study states: “Lack of monitoring systems for adherence could lead to misinterpretation of data on the effectiveness and safety of a treatment.” [1] With the average cost per person within a clinical trial being $38,000, the current inefficiencies in their processes are something that organisations cannot afford to ignore.
The challenges of remote working
The COVID-19 pandemic has forced many organisations to operate remotely where possible in order to prevent the spread of the virus. This new move to working remotely has brought some of the inefficiencies that exist within clinical trials to the surface, in particular a continued reliance on paper-based forms. The GMP 21 cfr part 11 has had guidance in place since 1997 which allows organisations to move towards using electronic signatures and digital documents and records, yet 24 years later, many have not made the switch. This now adds yet another blocker to the process, as patients cannot travel to clinical trial centres to complete paperwork in person during lockdown, nor can monitoring visits and their accompanying paperwork. Digital methods are needed now more than ever.
We were due to speak at several key industry events this year. Due to current circumstances, these cannot go ahead in person so instead, we’ve recreated our event stand online and pulled together our QHSE experts alongside some key resources which introduce how our software solutions can help you move towards digitalisation and clinical trial technology to support your processes. Join us online to find out more.
[1] Cambridge Consultants, ‘How Technology is Driving Digitalisation’: https://www.cambridgeconsultants.com/sites/default/files/uploaded-pdfs/Clinical%20trials%20-%20how%20technology%20is%20driving%20digitisation_1.pdf
Deborah Nicholson
New business and Enterprise sales for governance, risk and compliance software solutions with over 10 years working in the global Life Science sector. Deborah specialises in the pharmaceutical sector as well as contract manufacturing, CROs, university research, biotechnology, vets and rural sectors.