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Compliance In Focus
Posted by Jacqui Lingler on Fri, Apr 12, 2013

Protocol Development - Is this Medical Test Really Necessary?

Regardless if you are reading this from a sponsor, site, monitor or IRB perspective, we have all Protocol Development  Is this medical test really necessaryworked on a protocol with a medical test that really seems unnecessary or obsolete, not to mention, difficult to obtain with in the time window specified by the protocol.

Some of these notable tests or measurements (think repeated height measurement during follow-up visits for an adult study) are carried forward from older studies where they were providing the sponsor with pertinent information. Other tests or measurements are based on entrenched medical practices in clinical settings.

Recently, the NY Times published an article titled “Doctor Groups Issue List of Overused Medical Tests”, which highlights and summarizes the effort of the American Board of Internal Medicine Foundation, in partnership with the magazine Consumer Reports, to build a list of recommendations of “don’ts” for largely unnecessary tests and treatments.

Perhaps medical device sponsors should take a look at some of these recommendations during the protocol development process. A couple that may be of interest to the medical device clinical research landscape:

  • American Society of Echocardiography recommends against the use of echocardiograms before or during surgery for patients with no history or symptoms of heart disease
  • The Society of Nuclear Medicine and Molecular Imaging recommends against routine annual stress tests using a nuclear heart scan after coronary artery surgery
  • Several groups advocated for the reduction in the use of CT, PET, and MRI scans for a variety of ailments
  • Avoid routine pre-op testing for low-risk surgeries with a clinical indication

Clinically noted over-used tests can be wasteful and put patients in danger without any added benefits. Similarly, in clinical research, unnecessary tests could deter the subject’s likelihood to participate in the trial, create unwanted protocol deviations, and cause unneeded stress or discomfort to the subject during participation.

Can you recall a test or measurement from a protocol that you worked on that seemed over-the-top, wasteful, unnecessary, or commonly not obtained resulting in numerous non-compliances? Do you think that protocol developers should consult more frequently with clinical standards when writing protocols?

Photo Credit: ORBIS UK

Significant Risk/Non-Significant Risk Determination

Topics: Medical Devices, Protocol Development, Medical Tests

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