3 Issues To Address Going Into Clinical Trials

Posted on

Clinical trials are important to how modern companies and organizations roll out new drugs and medical procedures. Whether this is your first time conducting trials or you have extensive experience, it's wise to assemble a checklist to make sure everything has been handled competently. Let's take a look at three of the most common issues clinical trial operation services firms address before getting started.

Building Databases

The first thing you should do is get together a set of databases that will help you study the history of the disease or procedure you're researching. Similarly, a database of individuals who have medical histories that track with what you're studying can be invaluable. By combining these two sources of data, you can identify biomarkers that will help you develop guidelines to be used by the clinical operation services team assigned to your trial.

Identifying Desirable Locations for Trials

Many trials need to be deployed in geographic locations that provide either genetic diversity or isolation in populations being studied. Working from the databases you've assembled, you can identify places where the population suits your trial's objectives in terms of affected individuals and sufficient numbers of potential participants. Although initial trials can be relatively limited in terms of geography, most studies will eventually need to expand to multiple locations to rule out local effects that may be overly biasing the research.

Practical Preparations

Setting out the parameters of a trial is essential. In addition to addressing questions about patient tolerance, there should also be answers about maintaining regulatory compliance and documenting procedures. The total of necessary materials for the trial, right down to items like the drugs themselves, syringes, pill containers, and even tablets and pens, needs to be established.

A schedule has to be set out, and money has to be set aside to pay administrators, doctors, and participants. It's wise to build in a surplus of participants to guard against dropouts, too. Effective accounting methods will need to be put in place. It's also absolutely necessary to keep regulators in the loop.

A final risk-benefit analysis needs to be produced. Working from studies of patient-references, essential questions about the potential benefits of a trial might have to be laid out in detail. If an acceptable level of risk is determined to be part of the trial, the last step is providing participants with the materials that enable them to provide informed consent.