FDA released guidance for improving the enrollment of diverse patient population for the clinical research trials. This diversity is quoted as race based but in health care sense diversity is the genetics, metabolic rate and the medical conditions of the patients. The medications work differently in people from different genetic backgrounds, having different diagnosis and in vegetarians.
In clinical research trials, researchers have medical, scientific and ethical responsibilities for the different varieties of patients and have to research for the drugs and medical devices that are going to work differently for every patient and the drugs that are approved for one variety of patient populations can behave differently for another patient population.
There are three different ways that can be used to tackle with this issue of diverse patient population as given below:
- Inclusions and exclusion criteria.
- Adaptive trial design.
- Recruitment strategies.
Inclusion and exclusion criteria:
This criteria is designed to reduce diversity in which the researchers select the specific patient population that are not using any medications but when the drugs are in market after getting approval then they will be used by the patients. IE criteria selects patient with less medical conditions and make them use FDA approved drugs even if they were not involved in research database. FDA is trying to reduce the inclusion and exclusion criteria and this can be done by stopping the behavior of cutting and pasting the IE criteria from phase two trial into phase three trial and moving directly to the phase three trials.
Adaptive trial design:
Adaptive trial design is based on micro protocols in which the phase three start when the phase two is completed with good data. This adaptive trial design is to design a trial that can have smaller changes while collecting data. This adaptive trial design gives the ability to make small adaptions instead of large swath of data and this help to complete the entire phase two and three. This adaptive trial design helps to get more diverse patient population.
Recruitment strategies should be changes and recruiters should look for the areas with more diverse patients for the trials and FDA gives a document in which they mention that house of worship, barbershops, beauty salons and community centers and selecting the patients. This can help to improve the recruitment and enrollment of diverse patients for clinical trials.
These are the strategies that can be helpful to improve the diverse patient recruitment and to fulfill the medical, scientific and ethical responsibilities.