Do you have a Clinical Development Plan?
Why do we need a Clinical Development Plan?
Well, many biotech and pharmaceutical companies, especially that are new in the industry, have limited clinical development experience. This puts them at a disadvantage as they do not foresee the future challenges and problems that they would face during the development period. Many experts cite poor planning as the most common reason for clinical development trials going over budget, costing more than expected and sometimes just abandoned because of lack of resources, wasting all the effort spent.
What is the Scope of a Clinical Development Plan?
The clinical development plan generally focuses on the early phases of drug development. It outlines the hypothesis that the trial is going to test and the study methodology that would be used to test the hypothesis. Defining the hypothesis is very important as it helps in identifying decision points in the study which would invalidate the hypothesis - indicating that the study objectives should be re-evaluated. An optimal clinical trial design is planned to flag safety an efficacy concerns as early as possible in the trial, helping save the company time and money.
Other than the hypothesis and outline of the study, a good Clinical Development Plan should clearly define:
- Time needed to conduct individual studies with all the milestones clearly defined with entry and exit criteria
- Amount and type of resources required for each trial. It should clearly identify the level of expertise required to conduct individual tasks
- Amount and quality of data that should be collected and analyzed as part of each trial. As we discussed earlier, many companies with less experience in clinical development tend to collect a lot of redundant data (because they don't plan ahead regarding what data is relevant to their study) and then end up wasting a lot of time cleaning and figuring out what to do with it and how to analyze all the data
- Risks and the mitigation plan - financial for not meeting the study enpoints
Does your company spend enough time on designing a clinical development plan before jumping into the trial? Please let us know your thoughts or contact us if you have any questions or need further information on Clinical Development Strategy and Planning.