Service Insight: Clinical trials – managing route to market
pharmafile | May 11, 2011 | Feature | Research and Development | Service Insight, Talking Point, research and development
SERVICE INSIGHT
Clinical trials are notoriously difficult to manage and often fraught with problems, as they can involve many clinical sites and different teams of individuals within disparate organisations, who may or may not have previous experience of collecting, handling and shipping the different types of clinical specimens and the data associated with the trial.
This is especially true of global clinical trials where there may also be ‘cultural’ differences between the sponsor, the CRO and the sites.
These differences need to be realised at an early stage to ensure that management processes remain focused at the trial level.
The trial team, especially the project managers involved, whether they be from the CRO or the sponsor, should be experienced in motivating and co-ordinating the clinical teams so that everyone is moving in the same direction, rather than many paths at once.
A comprehensive study protocol with clear deliverables and responsibilities is paramount, as this will facilitate better communication and planning between the CRO, the sponsor and the specialist provider, especially if it takes into consideration the barriers associated with clinical sites.
The barriers can be numerous and include the ease of taking the sample; concern for the patient and their well-being; uncertainties around consent; time constraints; clear instructions on what actions need to be performed to follow the trial protocol; and the impact of the overall demands of the trial on the everyday working life at the clinical sites.
If these barriers are not addressed compliance with the protocol could be an issue, as may the ability to achieve the desired milestones (such as recruitment of the required number of patients) within time limits agreed for the trial.
Education of all personnel at the clinical sites (including clinicians, nurses and support staff) is paramount to ensure that samples are collected efficiently and safely. Where some management teams may see this as a step to bypass or to rush in their eagerness to initiate the trial – our experience has shown the dividends it pays once the trial commences.
It is crucial to get the clinical trial manager(s) and scientific team(s) on board at the earliest possible stage, and to utilise their experience to critique and identify any potential problems associated with the clinical protocol and proposed technical procedures sooner, rather than later. They will have valuable information to pass onto the medical team drafting the clinical protocol.
All of these considerations may seem cumbersome and time consuming, but not all is doom and gloom. There are tools which can facilitate trial management and monitoring which have been published on the MHRA website, and can be downloaded by those who manage and monitor clinical trials.
In brief, the MHRA suggests a ‘risk-based approach’ to clinical trial management with back-up plans if the trial starts to deviate.
The documents are available to ‘assist’ researchers in designing clinical trial protocols which meet the trial’s objectives, but also to identify and manage the risks associated with the trial pathway. The documents also take into account the overall quality of data which can be expected from the trial.
The key factor to identify is the starting point – What are the objectives of the trial?
These should be laid out in a clear format for discussion and agreement when the trial is being designed. Once these goals have been clarified, it is then possible to start putting in place the building blocks around the trial protocol, such as the number of patients/samples required to provide statistical power to the trial; the inclusion/exclusion criteria of the patients who can be enrolled/randomised; the assays or tests required to provide appropriate measurable endpoints for the drug or therapy under test; and the timelines and the risk of assessment associated with trial participants. Once these are understood the management systems for each of these parameters, as well as the procedures for monitoring can then be established.
Procedures for monitoring should include SOPs and Gantt charts as well as electronic CRFs which should be standardised between clinical management teams.
Regular teleconference or team meetings should also take place to ensure progress is on track, and if they are not, then the back-up plans and procedures should have been agreed during protocol design to progress the trial.
Data management and access to data for all of the relevant teams for discussion is also important. This can include access to secure web portals so that data can be quickly and safely shared as the trial progresses.
Change control processes for study documentation (including trial protocols) should be documented at an early stage if agreed milestones are not reached.
The bottom line for successful clinical trial management is successful project management with an experienced team with clear communication channels and objectives, and a set pathway which can be monitored easily and effectively as the trial progresses.
Simon Palmer is head contract management at Source BioScience. For more information visit: www.sourcebioscience.com
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