Six Things to Consider When Selecting a CRO for your next Pain Trial
March 9, 2017
Another obstacle we see is that some sponsors estimate site budgets too low rather than market value for site payments. While we do our best to negotiate the best site agreements we can on behalf of sponsors, unreasonable budget expectations can lead to a study not being able to initiate enough (or the right) sites. The costs in timeline extensions often exceed the costs of offering market-based site payments upfront. Your CRO should be able to provide you with market-based estimates for site payments based on your study design and their experience in similar studies.
2. Subject Reported Data
If an abnormal value entered by the subject is discovered in your data, the site cannot go back and request a clarification. For example, a subject reporting only to one extreme – all 10s say, or all 1s – is not considered clean data. In an acute pain trial, it would need to be determined how to best represent these outlier data. In a chronic trial, the study team and CRAs must revisit the site for retraining purposes.
3. Data Monitoring
To manage this, many sponsors require that CRAs for pain trials have a certain level of experience. As a result, sponsors should be mindful to ensure their selected CRO can meet these expectations for staffing purposes.
4. Drug Preparation
5. Diversion & Misuse
Because pain, is not necessarily a visible condition, site staff need to be diligent in recognizing suspicious behavior and detecting drug-seeking individuals. This is another area where a well-trained site can make all the difference. It is imperative to consider these points during the site selection process.
6. FDA Approval
Ultimately, there are many considerations a sponsor must make when selecting a CRO for a pain trial. Trained and experienced project staff are key in keeping trials moving forward with ease, detecting potential issues and monitoring vast quantities of data quickly. Any CRO seeking work on pain trials should also be prepared to demonstrate positive relationships with study sites, which can help ensure good subject recruitment and produce clean data.