Testing Drug Efficacy Using Electronic Medical Records
Regardless of where one may stand in the debate over solving rising healthcare costs, few would argue that the application of new information technology tools will have to play a major role. The link between new technology and reducing the cost of clinical trials is growing stronger thanks to a team of researchers at the University of Pennsylvania School of Medicine. The group conducted a study showing how implementing electronic medical records (EMR) and bioinformatics may be used to test drug efficacy.
“Our findings show that if you do studies using EMR databases and you conduct analyses using new biostatistical methods we developed, we get results that are valid,” said Richard Tannen, MD, a professor of medicine at the university, in a prepared statement. “That’s the real message of our paper: this can work.”
Large EMR databases contain huge amounts of medical information that could provide some insight into how a drug works within a large a diverse population, not only for those who participate in randomized clinical trials.
Critics argue that the information in these databases is observational. To address this issue, the research team chose six previously performed randomized trials with 17 measured outcomes and compared them with study data from the UK general practice database (GPRD). The GPRD contained the medical records of nearly 8 million patients. The objective was to apply the team’s bioinformatics technique to gain information about drug efficacy and prove the validity of their results against the data from the actual trials. Their technique showed no difference in the outcomes of the GPRD database and the clinical trials regarding drug efficacy.
Researchers explain that much larger (about 10-years worth) databases are needed to apply this technique, and addressing concerns regarding privacy and validity will be a challenge. Supporters are waiting to see whether the $900 billion stimulus package currently under discussion in Congress will come through with the proposed $20 billion for electronic health records.
Maybe I am missing a connection or intent but to implement this type of evaluation would have to run large studies for 10-15 years, collect the data to prove works (or also I presume applied to certain SEs). Data collection via EMR may help gather info faster, and with greater inherent consistency, but still requires patients on the drug with current focused Phase IIIs approach likely exposing less people sooner. Application upfront would lengthen the pathway to approval, raising costs and further diminishing available Patent life post-approval. Time is always (the most?) critical factor in projects which sometimes Academics don’t appreciate well.
If this is means of demonstrating efficacy can’t the reverse correlation be offered that the randomized clinical studies system are providing reliable data on efficacy that is supported by such long term database/analysis with EMR. This all sounds like good Phase IV type monitoring which should be occurring anyway and the more data the better, especially if quality standardized.
Testing the efficacy and safety of a drug via assumptions will prove harmful. This article seemed more of a marketing advertisement for EMR companies. I hope not too many people are falling for the notion. The only way to prove the efficacy and safety of a drug is to try it in real people – not technology.
Actually, the research and development of drugs needs to be slowed down not sped up. Big Pharma has got the world fearful that drugs are not available to those who need them. The truth is that Big Pharma just want more profit. What is overlooked is that Pharma uses at huge portion of their clinical research budget for marketing purposes. Especially Phase IV clinical trials which do nothing but get patients using drugs given to them during post-market approved drug studies. It is a marketing technique to get patients hooked on their drugs under the quise of a study. Take away the costs of research that is not used for marketing efforts – the cost of getting drugs to market is a lot less than PhRMA reports.
I know enough about research to know that data can be manipulated to reflect any desired result. I am suspicious the “techniques” used by the folks who did the studies on EMRs had everything to gain by using “techniques” that were favorable to them. This is simply another business that is trying to make money from clinical research. I see their advocacy of EMR and technology for what it is – marketing.
The other business does not work is Electronic Data Capture systems or EDCs. As a clinical research professional I know these systems only help data managers and allow the data to be more easily manipulated. I have seen EDC allow for more cheating and fraudulant data. EDC do not produce more valid or reliable data – just the opposite.
I am sure that wrongful assumptions used with EMRs will get more harmful drugs to market. Better there are fewer good drugs available than a slew of harmful drugs. Technology is not the answer – good clinical trials that actually put the drug through a honest “trial” in real people is the answer. That takes time and honesty not technology.