How to execute winning clinical trials

clinical trials, success factors, fda, investigators, safety

While there may be more general success factors when it comes to clinical trials, it is important to note that each clinical trial will vary by phase of development, patient population and therapeutic area.  However, I have compiled a short list of general success factors associated with winning clinical trials.  Feel free to add more below in the comments section.

  1. FDA: Adhere to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) which is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws and/or regulations. The FDA's regulations for the conduct of clinical trials, address both GCP and HSP.
  2. Clinical Investigators: Organise an exceptional team of clinical investigators and staff who will coordinate patient screening and care, and also handle the necessary record keeping and reporting to support regulatory submissions.
  3. Clinical trial capacity planning and forecasting: Transform your clinical trial capacity planning and forecasting from an important area of concern to a critical success factor.  Kenneth Kaitin, director of Tufts CSDD, said, “Most drug companies historically decentralized their approach to capacity forecasting, which made it difficult to coordinate scarce resources. Going forward, companies recognize the need to transform capacity planning into a core competence based on an accurate understanding of resource costs.”
  4. Patient safety and data reliability: Well, 3 in 1 here as this article splits its success factors into 3 based on the phase of development-

Phase 1:  Safety monitoring and accuracy of PK timepoints and sample handling
Phase 2:  Safety monitoring and accurate data collection for biomarker or efficacy endpoint
Phase 3:  Reliable efficacy endpoint collection; targeted safety monitoring

This is by no means an exhaustive list, so please add any more tips or success factors that you have found work.

Want to know more about the basics of clinical trials?  Read this informative article

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