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By Dr. Dorothy L. Smith
Internationally recognized expert in patient education, patient compliance, and behavior modification programs and author of 23 books for consumers on prescription drugs.

Improving Compliance by Informing Patients Vol.7 No.2
  
 
AVOID POST-MARKETING DILEMMAS

It is a dangerous assumption for pharma companies to assume that patients are taking their medications 100% correctly in clinical trials.

Drug companies have much to fear if their consumers do not understand how to take their medications safely and wisely.

Your clinical trial results will not be accurate if your study patients cannot understand:

  • administration instructions
  • risk information
  • how to recognize early symptoms of side effects and when to report them to clinical trial staff
  • why it is important not to change the dosing or miss doses
  • why it is so important to report any missed or extra doses in the patient diary.

To avoid post-marketing dilemmas, a patient compliance strategy should be developed in Phase III so that the clinical trial results approximate real-life situations.
 

WWW.CLINICALTRIALS.GOV

Pharma companies are being encouraged to post clinical trial summaries that consumers can understand.

In the aftermath of all the negative publicity surrounding several blockbuster drugs and the highly publicized settlement terms between NY State Attorney General Eliot Spitzer against GlaxoSmithKline, there are many questions regarding the quality of information needed by consumers through a public trial registry.

The International Committee of Medical Journal Editors (ICMJE) was the first committee to take action. Registration in a public clinical trial registry is now required as a condition of consideration for publication. The only registry that currently meets the ICMJE requirements is the National Institutes of Health (NIH) sponsored website www.clinicaltrials.gov.

In response to concerns that companies in the pharmaceutical industry have failed to properly disclose important information, the Senate and the House of Representatives have also introduced legislation to require mandatory public registration in a Federal registry of all clinical trials.

The American Medical Association (AMA) and NIH have also called for changes in the system.

The challenge for pharma companies is to make sure the information they post for the public is written in a language that consumers can understand.

 

PATIENT PACKAGE INSERT

 

 

Companies with whom we have worked with that have replaced their highly technical Brief Summaries with Patient Package Inserts (PPIs) have a headstart on a strong patient compliance program as well as a brilliant competitive edge.

By developing a PPI for the clinical trial, the company has a head start for the product launch and will have all the clinical trial patient comments on the wording so that when it is submitted to FDA as part of the NDA, there is actual patient experience behind the wording.

 
 
PATIENT MISMANAGEMENT OF STUDY MEDS
While patients in a clinical trial may be slightly more compliant than the post-launch patients, there is still a great deal of uncertainty over how often patients are missing or forgetting doses.

If the patient does not understand the medication instructions and any required record keeping, there is a high probability that the patient will make medication errors.

These errors can have a severe negative impact on the clinical trial results... including the dosage. Click here to find out how to improve the adherence rate in your clinical trials.
 

Danger: Are Patients Misusing Their Study Meds in Your Clinical Trials?

In every clinical trial, the role of the patient is critical. The decisions that patients make can significantly impact the trial results.

The study design and participation of health professionals may be flawless…but if the patient does not understand the medication instructions and is not motivated to take the study medications as prescribed, the results of the clinical trial will be flawed.

A patient compliance strategy can help ensure more accurate clinical trial results and help prevent these post-marketing dilemmas.

It is not uncommon for clinical investigators to assume that medications taken during clinical trials are taken correctly. This is a very dangerous assumption to make. While it is unreasonable to expect 100% compliance in a clinical trial, the investigators need to identify a patient medication adherence level that will be adequate to allow testing against a control or comparison treatment.

Research is demonstrating that many patients are overestimating their adherence and not providing the study investigators with honest self-reports.

The Needs of Patients During Clinical Trials

Poor adherence is not the patients’ fault. Patients try their best to make good decisions about their medications and when they make a mistake, it is usually because they do not have all the background information they need or are afraid to tell the physician they have made a mistake. To reverse this, there are two issues that must be addressed in the study design:

Make Sure Patients are Compliant with Their Study Meds

If patients do not feel free to discuss their problems in carrying out the trial instructions, they usually “cover up” the problems so they can please the study team. In the Lung Health Study, a 5-year clinical trial sponsored by the National Heart, Lung and Blood Institute of the National Institutes of Health, 14% of the participants had at least one medication dumping episode during the first 4-month follow-up period. A follow-up study extended the result to the first year and reported the following:

Self-reported inhaler use and canister weights usually indicated satisfactory compliance with the study protocol even when dumping had occurred. The authors concluded that deception among noncompliers occurs frequently in clinical trials, is often not revealed by the usual methods of monitoring and cannot be predicted by data readily available in clinical trials.

These findings have wide-ranging implications.

Make Sure Patients Understand the Information Given to Them

The majority of written and verbal information given to patients during clinical trials is not presented in language they can understand.

Patients need the following understandable clinical study materials during Phase III - and even Phase II:

  • Patient education materials including brochures, videos
  • Informed Consent documents
  • “How to Take” Patient Medication Instructions
  • Patient Diaries & Personal Progress logs
  • Study Packaging

By motivating patients to take the study medication more accurately, Phase II and Phase III study results will reflect a more accurate side effect profile and more accurate dose.

Conclusion

The key to improving patient management of medications during the clinical trial is to identify all the potential patient compliance variables and then develop appropriate educational and behavior modification strategies to address each variable.

For more information about how Consumer Health Information Corporation can help you develop understandable patient education materials for clinical trials click here.

NEWS

Consumer Health Information Corporation won the Gold Award in the 2004 National Health Information Awards for Fujisawa's Transplant Mentor Program.

This is the second year in a row that Consumer Health Information Corporation has won this sought after award. Fujisawa's DTC educational program is a good example of what companies can do to take patient education beyond the norm.

This is the first patient education training program of its kind used in hospital transplant centers in the United States and consists of an integrated training program for both mentors and their mentees. Click here to read the press release.
 

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