Industry commentators have claimed that we could be entering a clinical trial equipment rental age....
A vast majority of clinical trials face postponements, costing precious time and money and impacting patients, which why managing time, resources and participants are crucial in avoiding delays and providing results.
An estimated 85% of all clinical trials will experience delays; 94% of those are delayed by over a month. The financial impact, as a result, can be massive, costing between $600,000 to $8m every day.
As well as the immediate impact on clinical trial budgets, delays can impact the long-term profitability of a drug by reducing its patent window. Estimates vary and are contested but whether measured in pounds, dollars or euros, the amount of money lost in clinical trials delays is in the billions and increasing year on year.
While it’s important to recognise the financial implications of delays, there are some human implications too. Hold-ups may place an unnecessary and unwanted burden on patients, which could lead them to exit trials, further exacerbating the problem. Furthermore, delays getting drugs to market means delayed treatments, potentially affecting patient outcomes.
We explore some of the common reasons why clinical trials experience delays and what you can do to avoid them.
A Nature analysis examining the causes of clinical trial delays found that strategic problems, commercial barriers and operational issues were to blame in almost a quarter of all trials.
Similarly, increasing complexity and interdependencies between agencies and across borders put greater demands on project managers to meet deadlines. In recent times, endpoints in trials have doubled, with the average number of procedures per participant increasing by 58%.
Frustratingly, site initiation delays are common. Every member of staff should be armed with the correct policies and procedures, as well as fully calibrated and ready equipment to commence research activities on the site initiation visit (SIV) date. False starts due to missed SIV dates have an immediate impact on trial timelines and ultimately profitability for sponsors.
Once a trial is underway, the most common reason for delays is the complex and challenging area of patient retention and recruitment, with many studies failing to recruit in adequate numbers. A study by CenterWatch claims that 69% of patients fail pre-screening, 58% decline consent and 8% drop out after enrolment.
The importance of site selection is becoming clearer, with researchers adopting a more ‘patient-centric’ approach, where the patient’s point of view is considered. Having processes in place to receive notifications of poor uptake and approaches to ameliorate the impact is essential.
A ‘Business Approach’ to Clinical Trials
The complexity of clinical trials has increased and this calls for more robust and standardised clinical research procedures. Researchers are being encouraged to take a commercial ‘business approach’ to project management. To help adopt this approach, Imperial Clinical Research Services have created a useful and in-depth guide for clinical professionals on project management.
Similarly, having a tool like a commercial clinical trial management system (CTMS) can help. A CTMS can provide a rigorous and methodical approach to preparing all documents, policies and procedures to support your research, locate them all in one place and help you to manage time effectively.
However, it is not just processes that need improvement. Ensuring clinical research sites are ready to begin receiving patients by the site initiation visit is essential. At MESM, we can work across all of a customer’s study sites to ensure the ancillaries and equipment meet protocol requirements and are ready to use before the trial begins.
Running a clinical trial is complex, but Claudia Schaft at the European Project and Research Office has four simple tips for minimising delays:
- Start work immediately: Be proactive in managing potential delays
- Revisit site assessments regularly: Review all procedures and processes
- Be adaptable: Review your project management approach, and change if necessary
- Build relationships: A responsive project management team needs responsive relationships
Delays in clinical trials are common but not unavoidable. By understanding the potential risks and putting processes in place to combat them, your trial can be a success both for the sponsor and the patients taking part and all within the trial budget too.
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