Medical Data and outcomes - Our goal is to evaluate and shed light on the various methods of medical data collection and evaluation/ analysis of the data produced by each method. This group will review methods of data collection and discuss both the pros, cons, cost and effectiveness of each methodology. Ultimately our goal is to assist members of the “ Medical data community” ( HEOR, Post market surveillance, Real world data evaluation, physician and medical liasons, pharmaceutical and medical device companies and many other key stakeholders) to best determine the type and methodology of medical data collection and evaluation that best suits their needs and situation.
The field of medical data collection and evaluation for HEOR, Post market surveillance, Real world data evaluation, physician and medical liasons, pharmaceutical and medical device companies and many other key stakeholders is one of the fastest growing markets / industries in our world today.
We are all aware that healthcare costs continue to rise - for the Pharmaceutical and medical device companies- the latest publication from Tufts CSDD, ( Center for Study of Drug Dev) shows the average R&D costs to be bring a new drug from inception, through all phases of clinical trials, to market is around $2.6 billion. R&D costs and risks for some of our new biologics have even higher cost than non-biologics.
So pharma and med devices are under all time high pressures to prove safety and value of their products and that their products are truly best treatments.
A report recently published by PharmaForce International earlier this year ( 2017) revealed that pharma companies increased their field-based HEOR personnel by 53% in 2016 alone. Proving the rapid growth of this industry.
Beginning our evaluation of data collection and evaluation methodologies – let’s 1st examine:
Clinical Trials – scientifically controlled study of the safety and effectiveness of a therapeutic agent (as a drug, vaccine or medical device) using a tightly controlled and predetermined group of consenting human subjects – typically before approval and widespread use of a product.
CHALLENGES: limitations on the data obtainable in clinical trials could potentially result in a limited – or distorted understanding, due to constraints of participating patients selected for the study. ( small groups of patients with specific characteristics are used in the clinical trials )
Data from the clinical trials focus only on patients selected for the trial, questions focused on during the trial and for the time / duration of the trial. The data collected and evaluated does not include large data sets as we get with PMS and RWD.
So many other factors can be exposed, once the product is actually launched onto the widespread market. Positives – we learn there can be a number of “ off label “ uses for products that are extremely beneficial to patients. Negative Example: COX 2 NSAIDS- side effects were seen after widespread release that were not seen during any of the clinical trials.
Please share your experiences with differences seen in product performance, advantages and side effects between clinical trials and widespread release of the product. Your thoughts and experiences on this method of data collection and evaluation are extremely valuable to your colleagues in the Medical Data Community