Clinical trials are extremely important for measuring the safety and efficacy of a range of drugs, vaccines and medical devices. They are essential but costly and so manufacturers running trials will not want to waste any time or money unnecessarily. Delays cost money, time, prevent new treatments becoming available and impact patients and volunteers. It is estimated that 85% of trials experience delays with many being delayed for over a month.
Delays in trials can cause more issues than just costing additional funds. A significant delay can impact the overall profitability of a drug, as well as reducing the time available to patent it. The financial amount lost through delays in trials is in the billions and is only increasing year on year.
There are human impacts too, such as placing additional burden on patients and volunteers. This could result in people dropping out of trials which will only exacerbate the delays even more. Delays also impact people with conditions or diseases who will have to wait longer for potential help from new treatments. For information on Paid Clinical Trials, go to www.trials4us.co.uk
What causes trial delays?
Strategic, commercial and operational problems are all reasons why trials can get delayed. More complex procedures and reliance on other agencies, sometimes in different countries can also create problems. Site initiation issues are also common, leading to missed start dates. Once trials are underway, volunteer retention and recruitment causes problems with many participants failing pre-screening or dropping out after enrolment.
Here are some ways to prevent delays in clinical trials:
Adopt a ‘business’ approach
As clinical trials become increasingly complex, there is a greater need for a more robust approach to the processes involved. Researchers are being encouraged to think of trials with a commercial outlook and focus more on the project management aspects. Commercial clinical trial management systems can help to standardise processes and protocols with everything stored in one place for ease of access to help time management significantly. Once processes are improved, the whole project can run much more smoothly.
Before a trial even begins, it is important that the site is ready to receive patients and participants. It is necessary to ensure that all equipment and ancillaries are ready for use and protocol requirements are met before the trial begins.
Work must start right away and a proactive approach be taken when any suspicion of delays arise. All procedures should be reviewed regularly to remove any pinch points or possible delay situations. Regular site assessments will ensure that all procedures remain up to date and relevant.
Being adaptable is one of the most important things to achieve in order to reduce delays and problems. Adapting means being able to change or modify a project management approach if necessary.
Building relationships is also key. Being a responsive project management team will be greatly assisted by responsive relationships with other stakeholders, suppliers, health authorities and patients.