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Clinical Trial Planning

Clinical trials represent the most important part of a drug development cycle. However, as high as 85% of all clinical trials will be completed with delays, creating unnecessary costs. At HYGEIA Research, we know that it is indeed possible not only to decrease delays but to avoid them, and that even most complexed clinical trials can be completed on time. We strongly believe that the key to a successful clinical trial is in detailed, educated and data-driven clinical trial planning.

Good planning for us means predicting uncertainties, identifying strengths, opportunities, threats and weaknesses, and creating the most efficient success strategies for your trial, and this can be done as a part of stand-alone feasibility projects, site outreach or feasibility analysis and data-driven study strategy.

SERVICES

Stand-alone Feasibility Projects

Stand-alone feasibility is the most comprehensive and complexed type of feasibility analysis. When performed before the study starts, it enables gathering and analyzing critical information for setting a strong basis for clinical trial success.

As a part of stand-alone feasibility, at HYGEIA Research we will conduct several key analyses, such as: competitive market landscape research and analysis; epidemiology of the disease analysis; regulatory analysis; analysis of treatment standards and treatment practices across different regions, countries and sites. We will also conduct medical and expert’s review of clinical trial protocol and analyze logistical aspects of your clinical study.

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One of the keys of stand-alone feasibility is to analyze the investigators’ recruitment potential, evaluate their experience, suitability and motivation for your trial. We will also gauge motivation of patients to take part in the study and stay compliant throughout.

At HYGEIA Research we will perform SWOT analysis for your trial and point out the strengths, weaknesses, opportunities and treats for your trial, as well as the suggested mitigation plan. We will help planning your clinical trial by presenting the most successful strategy/ies for clinical trial conduct and completion.

The results of stand-alone feasibility, together with all types of analysis performed, suggested strategy/ies and the final list of sites will be provided to you a detailed feasibility report.

Site Identification and Outreach

The importance of selecting the right sites can be best understood in the light of statistical data that suggest that nearly one-third of the sites performing clinical trials have never enrolled a single patient. That is more than 33% of all participating sites, and in certain geographic areas the percentage is over 40%. Moreover, it is stated that, in a typical trial, more than one-third of sites under-enroll patients and roughly one-tenth of them fail to enroll even a single patient.

Sometimes it can happen that the selected sites have access to patients; however, they do not have time or resources, or might not be motivated due to complex internal administration, or lack of research interest.

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Understanding the motivation and performance potential of the sites as early as possible in the process and finding ways to maximize their engagement will have multiple benefits on the success of trials.

Whether you have already selected countries for your clinical trial, or have narrowed your list down, we can help you with selecting the right sites for your clinical trial.

Our team will identify the key opinion leaders (KOLs) in countries of interest, as well as other potential sites for the study. We will conduct site outreach to gauge site recruitment potential, motivation and suitability for the study, and help you select the right sites for your study.

Data Driven Study Strategy

Pharmaceutical and CRO companies typically invest approximately one week in performing feasibility analysis and planning for their clinical trial, if planning is performed at all. This time is not sufficient for gathering and analyzing critical information and making decisions that will enable clinical trials to be conducted and completed on time. Due to short timelines, key decisions for conducting clinical trials are often based on previously completed trials with similar design, or on the company`s experience. While experience in trials with similar design can be helpful, it can also be misleading, especially in a high-paced industry like this one, where important elements of the study protocol can easily be overlooked. Every clinical trial is unique; therefore, it would be more useful to look at the experiences gathered in previous trials with similar indication as an important piece of the puzzle – important, but still insufficient for making the right decision.

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The best way to get the full picture is by conducting a detailed feasibility analysis, preferably as early as possibly in the clinical trial process.

The chance is 80% greater that a clinical trial planned based on a data-driven analysis will be completed on time, with no unplanned costs. We can help you plan your clinical trial based on adequately targeted, collected, filtered and analyzed data.

Recruitment Analysis

Roughly 85% of clinical trials fail to meet enrollment timelines and approximately one-third (30%) of phase III study terminations are due to enrollment difficulties.

Both CRO companies and sponsors are aware of these difficulties, and they often seek direct recommendations of site investigators for estimates of patient enrolment. The most common way to collect this information is through feasibility questionnaires. These questionnaires can be simplistic, typically focused on the number of patients who fit the study criteria treated by the investigators, and how many they believe they would be able to recruit for an upcoming trial. Or they can be the opposite, too detailed, asking questions about the site’s administration and questions that are not crucial for understanding the site`s performance, thus minimizing the motivation of investigators to complete them.

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The majority of investigators tend to overestimate their recruitment potential, and CRO companies, being aware of it, will typically try to mitigate the overestimation risk by decreasing investigator estimates by 50% or 30%. Neither of these options is accurate. We would rather say that these are educated guesses, as they rely on non-bounding estimates of investigators, typically based on incomplete information provided in a rush.

Opposed to relying on the investigator`s estimates, at HYGEIA Research we are using specific analysis methodology that enables calculating realistic recruitment potential of sites and planning clinical adequately.

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