Phase IV Trials
Phase IV studies, conducted following the approval of a medicine for marketing, often involve thousands of subjects and can continue for many years. The key objectives at Phase IV are to:
- Compare the drug with other drugs already available on the market
- Monitor the drug's long-term effectiveness on a patient's quality of life
- Determine the cost-effectiveness of a drug therapy relative to other existing or new medicines.
Slow and inefficient patient recruitment causes significant delays in Phase IV trials and cost the sponsor many thousands of dollars each day. Primary care physicians are often reluctant to become involved in these trials which can be burdensome from a time perspective. For those doctors who do take part, their recruitment of subjects is mostly opportunistic and frequently takes a lengthy period of time.
In an effort to address the delays caused by patient recruitment, Synexus has worked closely with pharma clients to develop a model which involves more primary care doctors and their patients in Phase IV trials, but without the doctor having to actually run the trial. This model also provides each doctor with better information on the performance and results of the trial.
Synexus approaches primary care doctors practising around its Dedicated Research Centres in the UK, Poland, Hungary, Bulgaria, South Africa and India:
- Those doctors who are interested are provided with an in-depth briefing on the medicine and the study
- The selected doctors write to all eligible patients in their practice - Synexus can provide help in doing this
- Responses from patients are then channeled to Synexus who undertake the necessary screening procedures
- Each doctor is informed of the enrolment of their patients. The doctor provides a report based on the medical history of each patient, an SVD (source verification document) for an agreed fee
- As the patient progresses through the trial, the patients doctor is kept up-to-date through regular briefings
- On conclusion of the trial, the doctor receives an in-depth briefing of the results relating not only to their patients, but also to the whole study cohort.
This approach has been welcomed by busy doctors, and in the Phase IV trials carried out by Synexus it has led to a significant rise in the number of doctors involved. As well as being more effective in enrolling patients, the Synexus model speeds up the the entire recruitment process and reduces costs.
The benefits of this model
- One point of contact; one contract; one data collection point. Resulting in a considerable reduction in costs
- Service Quality Management Systems (SQMS) is implemented throughout and all data collection is checked internally prior to the client's monitor checking the output
- Improved patient retention
- Doctors benefit from comprehensive briefings on the progress and outcome of the trial
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