Early Patient Research Leads to Better Protocols

Nils Drews, Chief Medical Officer

A new analysis of global protocol amendments by the Tufts Center for the Study of Drug Development concludes that most protocol amendments are needed to modify eligibility criteria and subject demographics. Importantly, the report also concludes that nearly half of these protocol amendments are avoidable.

In addition, the report noted an average of two amendments per study, which range in cost from $141,000 to $535,000 per amendment. This new information illuminates growing industry recognition that 70% of the money expended in drug development is wasted[1].

Successful studies start with sound protocol design. In turn, efforts to optimize protocol design stem from a comprehensive understanding of the target patient population.

There are many industry-wide efforts to engage, and learn from patients earlier in clinical development to inform trial design, country and site selection (among many other reasons).

Patient surveys are a cost-effective and efficient way to gather important patient data to support these decisions. They can be used to better understand the patient population in many ways:

  • Learn about the major daily challenges of living with a specific disease, as described by patients
  • Gather specific motivations and barriers of clinical trial participation
  • Learn patient preferences for tools to help medication adherence and/or study compliance
  • Determine who the actual patient population are within the context of the inclusion and exclusion criteria, and where they live

What’s more, if a protocol contains elements that are known patient burdens, patient surveys are an efficient way to determine what additional resources may be necessary to attract a patient group and promote study retention throughout a trial. By applying survey findings to minimize non-critical research activity, the study protocol has a better chance of translating into clinical trial success.

Patient surveys are an evolving best practice in clinical trial feasibility. They are also the best vehicle to pre-identify patient populations for clinical trials. Ask Clariness about our broad experience in conducting patient surveys for clinical trials.

[1] Shoemaker, D, Kesler, K. Protocol Design and Development: What You Need to Know to Ensure a Successful Study, (Webinar) January 28, 2016 https://pages.questexweb.com/Rho-Registration-20160128.html