Saving limitations in the planning of clinical research.

January 27, 2021

Unpredictability and risks

The beginning of a clinical research project involves, in the vast majority of cases, an enormous degree of unpredictability, uncertainty, and risks. 

This unpredictability, inherent in any research initiative, implies that there are possibilities that the project will not be successful, understanding “success” as obtaining results that, ultimately, translate into improvements in health or that yield some kind of light on the causalities and correlations of certain diseases. This is a normal outcome when investigating and is an inevitable part of the discovery process: initial hypothesis; contrasting; Outcome; validation, reformulation or total discard of the initial hypothesis; and repeat the process.

In addition to the risks implicit in the nature of the research, there are others that depend on the planning capacity and the resources available for said project planning. Therefore, areas in which we can influence, and where important obstacles stand out, such as the following:  

Lack of data.

In planning this type of project, it is necessary to use existing clinical data to determine the scope of the study, which hospitals are going to participate, or if the project is even viable. However, access to this data is slow and complex, forcing researchers and promoters to work with estimates or very limited samples of data collected on an ad-hoc basis, exponentially increasing the risks associated with the project.

Inaccurate estimates.

The lack of available clinical data generates the need to resort to estimates based on samples or the experience of previous studies. These estimates usually do not correspond to the real need of the project, so it is not unusual to embark on studies and trials with incorrect estimates about the data that can be obtained in a time window.

Difficulty choosing the most suitable sites.

The perspectives to be evaluated when choosing a hospital as a participant in a project are multiple and complex, ranging from the availability of physical infrastructure to regulatory issues.

Many actors involved.

Many actors intervene in the feasibility studies carried out prior to completing the entire project, making their best estimates, based on the best available information and past experience. Undoubtedly, the multidisciplinary perspective is enriching, the existence of centralized, exact, and verifiable information would represent a huge advantage.

Time.

If you wanted to have total certainty of the times and processes necessary to carry out a clinical research project, it would be necessary to carry out a feasibility analysis that would take months. Of course, generating insurmountable inefficiencies.

Compass, the IOMED product to decide using Real World Data.

Faced with such a number of possible unforeseen events, the need arises to control as much as possible those areas in which risks can be reduced.

To this end, IOMED launches Compass, its new Real World Data instant query tool added to improve decision making in the area of ​​clinical research and Market Access.

What is Compass?

If you want to know more about what Compass is, don’t hesitate to contact us. Write to us at info@iomed.health