As with any industry, the challenges facing those working in clinical trials at the moment are numerous; from patient recruitment, to adoption of technology, and regulatory requirements, to spiralling costs.
Over the last year we have asked dozens of clinical professionals about the biggest challenges they are facing and the graph above shows their most common responses. Here, in part one of our two-part report, we delve into the top replies to discover what it is about these issues that are most challenging trials today.
Complexity of Trials (21% of respondents)
Clinical trials have been growing increasingly complex for years, and those running them are feeling the pressure to design trials ‘that give the right answers, in the most simple and unobtrusive way for patients, that are acceptable to regulators and payers’.
Respondents from study sites are particularly concerned with meeting the ‘challenge of focussing on the best study design’ for ‘very complex modern clinical trials’. Such concerns are borne out in the ‘high rate of failure to meet primary endpoints due to poor or complex design’.
Regulations (15% of respondents)
A predictable concern for an industry so heavily regulated, many respondents feel constrained by the complexity of the guidelines they follow. Additionally, the variations between different regulatory bodies, and the challenges that brings, comes up repeatedly.
As trials are increasingly looking to emerging markets in new countries, there is also the need to understand whole new sets of requirements.
Spiralling Costs (15% of respondents)
An inevitable result of the above two issues, the cost of trials is at an all-time high. Increasing complexity and tight timelines is putting more pressure on the ‘need for resources to implement and control every step’.
Patient access (12% of respondents)
Patient recruitment and retention are a major challenge for those running trials, with a high percentage not meeting targets and drop-out rates increasing. One respondent blamed the ‘increased burden for patients through study participation without adequate “return of investment” in form of personal benefits’. Such concerns explain the prevalence of patient centric approaches in today’s research.