Clinical Study Management: Skills on Offer

Clinical studies are not an easy thing to do, especially today. You have a lot of variables that have to be given consideration, and any mistakes made on any level of the study can result in the data being relatively sloppy. As time passes, clinical studies are dealing with more and more hurdles as well. These hurdles range from financial ones to finding willing participants to others. As such, when doing a clinical study, it is paramount that you have a partner that has the experience to understand these hurdles and get the data that you need in the end.

Clinical Study Structure

Clinical studies generally go on a four-step structure. The first step will be setting up the study itself. Planning out the budget, picking a site at which the clinical study takes place, checking out how good the potential participation in the study may be, etc. This phase is very important, as it often makes or breaks a clinical study. Poor planning could mean that you fail to meet your deadline, that you don’t get the number of participants than you may like, and/or your study may face delays. A quality partner in such an undertaking will have questionnaires set up to ensure that the right site is picked and that the needs of the study are met. Following the questionnaire, a follow-up should be expected to verify directly whether the site matches up, and you are given a report so you better understand what you are getting into. Finally, your partner will assist in negotiations, getting the contract and budget set up.

After you and the organization you have partnered with have gotten this all set up with the site, the next step will be to ensuring that the people at the site are able to get in line with what you want and need for the study. This process will go for an extended period of time, as long as is needed to ensure the study is handled properly. These training services may be done via online or offline methods.

Clinical Study Recruitment

Once everyone is up to speed and all ducks are ordered neatly in a row, then we can get to work on the actual recruitment phase, which we work closely with the chosen site to find eligible candidates who may be interested in participating. This is accomplished through a variety of methods, ranging from print advertisements to online advertisements to even outreach with the community. The more options you have with reaching prospective candidates, the quicker and more efficient the process is going to be. These can especially help due to some barriers involved in finding certain demographics. For example, a 2016 study found that recruitment rates for racial/ethnic minorities in a cancer trial were noticeably lower,[1] and efforts are needed to try and address that disparity, which may be more difficult without an experienced partner.

Finally, once the study has begun, your partner should provide oversight on-site that can make sure that it’s going like clockwork. It is important to ensure that everyone involved properly understands the protocol and report any deviations from the protocol. On top of that, it’s important to be kept abreast of any changes or activity going on with the study.