Informed consent—being it the criticality it is of the patient safety mechanism for clinical research—embodies challenges and complexities far deeper than may be immediately determined. To uncover these underlying issues that streamline in the informed consent process, Johnson & Johnson embarked on a test market exercise in which participants were given an ICF to review and then were questioned on its details to determine the level of understanding. Emily Walker, MBA, associate director, global trial manager, global clinical operations, Johnson & Johnson Pharmaceutical R&D LLC brought the details of this experiment with her to present at DIA’s 45th Annual Meeting on Tuesday morning.

Challenges leading to solutions
Of the marked findings of the experiment, Walker highlighted the parts of the ICF that participants showed difficulty understanding, including study purpose, randomization, double-blind, study procedure, placebo, side effects, and lactic acidosis.

With the challenges, Walker also brought potential solutions to the table for each. For the issues of understanding study purpose and study procedure, the solution proposed was to put a break in monotonous paragraphs. The idea was that people were losing focus when reading these areas and keeping it simple and including white space would relieve this issue.

Problems understanding the information on double-blind, randomization, and placebo was assumed to be taking place because people needed further explanation. Though there are no rules set in stone for putting together an ICF, the ICF Readability Requirements do note that the document should be written at a sixth to eighth grade level. A simple mention that double-blind means neither the patient nor the doctor will know the administered drug may not be enough. A deeper explanation detailing that double-blind also means no one will know the administered drug may be necessary.

Finally for side effects, rare occurrences like lactic acidosis or any information involving statistics, alternate ways of presenting the information, such as bullet lists and tables, were found to be more comprehensive options.

Consistency is key
As Walker discussed the various challenges found through J&J’s experiment, Lisa Mulcahy, independent pharmaceutical research consultant, drilled down into the odds and ends of the risk section of ICFs. One issue she noted was that of consistency in risk language and its tendency to be effected by yet another inconsistency—in the timing of updates.

To alleviate such issues Mulcahy suggests implementing a standardized risk language template and creating one of these templates for each compound that is maintained in the procedural document process. With these standardized templates the solution proposed is that updates can be scheduled or occur routinely in alignment with safety reviews.

Beyond keeping risks accurate and timely, Mulcahy also notes the significance of presenting this information in a thorough manner. As Walker had noted earlier, Mulcahy mentioned the use of tables, bullets, and magazine layouts for ICFs. When reporting frequency—something that is often misunderstood, according to Mulcahy—providing a frequency of risk table can be valuable.

“People read things differently…it’s about helping people to see information differently so they can understand in different ways,” Mulcahy said.

An India outlook
When it comes to the challenges and hurdles of informed consent, India is no exception, and certainly faces a much more tumultuous terrain ahead. While India’s market is expected to grow from $200 million in 2006 to $1 billion in 2010, Rajiv Prasad, MBA, assistant vice president of life sciences for Satyam BOP Ltd., speculates where the country will find the manpower to handle the large scale task of informed consent that exists for this region.

Looking past the challenges that developed countries face in this area, India also must deal with cultural, social, and literacy issues. As Prasad describes, physicians are looked at as Gods or healers. So, now talking about adverse events and full disclosure requires a level in which these patients must be educated and provided with very detailed explanations.

Beyond this there are 26 distinct languages in India, along with 250 dialects. The translation of an ICF into all of these dialects is nearly impossible, according to Prasad, and would require the involvement of language labs and universities for ensured accuracy.

There is no question India is a growing market, but it will need careful dedication to implement informed consent with the most minimal amount of dysfunction. Prasad suggests that the long term goals that must be taken under are educational campaigns, especially in rural and urban illiterate populations.