Reducing Study Complexity to minimize cost and burden of clinical trails
Faisal khan
June 5, 2023
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Reducing Clinical Trial Cost, Complexity & Burden
It’s widely known. The complexity of clinical studies is increasing, which raises the price of creating new medications. According to a recent analysis by the Tufts Centre for the Study of Drug Development (CSDD)a, this complexity has a detrimental effect on the effectiveness of clinical trials, the workload of those carrying out the studies, and the recruitment and retention of participants. However, it is a tendency that is only expected to persist as harder to cure and rarer diseases are targeted, more stratified and particular populations are enrolled, and more varied and substantial data are gathered.
It is quite easy to believe that by running as many tests and gathering as much data as you can early on, you are de-risking a project. Can you really afford the luxury of extra time and expense required at both the site and sponsor level, as well as the added strain it places on the study participants, when up to 40% of that data may never be used in the new drug application?
There must be a balance between having everything done and finishing studies quickly and affordably. But how do you predict what you won’t need in the future in advance? Working with your external partners to eliminate processes and data that are extraneous is the key to achieving this. Regarding the safety and efficacy data they anticipate, regulatory authorities have minimum standards. Clinicians will be aware of the contemporary environment and medical procedures. You may learn more about the value of patient involvement in our PREVIOUS POST. Patients can also help you understand how they receive care (recruitment paths), what they are willing to do, and what will support or impede their participation. Another option is to crowdsource assistance from people who do if you lack the established networks.
The following considerations may be helpful if you want to decrease research complexity (and hence lower the expense of clinical trials):
- Study design
- Study population
- Randomization
- The nature of your intervention
- Study sites
- Data collection
- Follow-up
- Practical issues