Medical drugs, devices, and instruments are vital in the healthcare industry. After a regulatory authority approves a medical product, it is then considered safe and an effective, and it can now be prescribed to the patient population in which the product is approved for use in. However, it is well-know that Phase 3 clinical trials cannot identify every possible safety concern or potential side effect of a new therapeutic. If a newly approved drug is in a new class, never approved before, the FDA may impose mandatory follow-up studies “Post marketing surveillance studies” to gather a broader understanding of the drug’s safety profile. These types of studies can be short of long-term – and any new findings may be added the prescribing information on the product label. Many drug manufactures consider these types of studies even if not mandated by government health authorities – and the patient registry is a considered a reliable method to conduct these studies. These types of studies are sometimes called Phase 4 – post marketing studies. As such, the use of patient registries for product safety evaluation has become quite popular.
Post approval or post marketing studies rose to importance after clinicians identified rare conditions surfacing after exposure to certain healthcare products. For example, thalidomide caused phocomelia, a limb deformity, on prenatal exposure. Similarly, women exposed to diethylstilbestrol (DES) had a higher chance of developing rare vaginal cancers than women who didn’t.
Limitations of Clinical Trials
After such adverse drug reactions came up, people have seriously started to question the efficacy of regulatory approaches in drug approval. However, there is a general agreement that the authorization of any drug or product does not mean that the product is 100% safe. But what it should do is weigh out the known benefits and the known risks, and the need to make said product available to patients who need it. For example, chemotherapy has several grave side effects, but it is required to fight cancer in patients. Because cancer is often a fatal disease, the benefits of saving a patient’s life is considered to out weight the side effects associated with the therapy and is therefore approved for using in those patients that may benefit.
The biggest impediment to identifying the risks associated with a product or drug is the limitations in the diversity and size of the population being tested in clinical trials. The known risks of a product perhaps only represent the safety profile of said product for a specific segment of the population, and not the others. This research is not inclusive of all types of patients, which means that the product may or may not be safe for a certain segment, the risks of which may only surface after use.
Use of Patient Registries for Product Safety
Patient and disease registries systematically collect data on eligible patients dealing with a specific disease or condition. What needs to be noted is that registries often use people who are not only different but more complex than those used in clinical trials.
You can use patient registries for product safety and evaluation. To be relevant and effective, the said registry should include information about the product under scrutiny. The data should include (but not limited to) the following:
- Dose of the drug
- Route of administration
- Time duration of use
- Brand of the medicine/product
- Other comorbidities
Disease registries collect data on patients dealing with a similar condition, and what treatment and drug (apart from the one being tested) was being used. They provide valuable data on the outcome, and side effects that can then be matched with other treatments patients may be utilizing in real world application. This is why patient registries that encompass a larger population can make significant contributions about product safety evaluation and assessment.
For any registry to be successful, you need the right, flexible and secure patient registry software solution. This will help you steer the registry in whichever direction you want, whether it’s targeted for patient outcomes or for the safety evaluation of a medical product.