Case for Digital Pill Uses in Clinical Trials Responses

Case for Digital Pill Uses in Clinical Trials Responses essay assignment

Case for Digital Pill Uses in Clinical Trials Responses essay assignment

Original Question: In the article “Do You Want Chips With That” published in Nature Reviews and Drug Discovery the author discusses use of digital pills. Proteus Health and Otsuka have asked for regulatory approval for a digital pill that combines the antipsychotic drug ariprazoli with an ingestible electronic chip that senses when the drug is taken. The article also discusses the impact on clinical trials to increase adherence. In clinical trials subject compliance is often a problem. Increasing compliance and/or being able to accurately detect whether a drug was taken or not, as opposed to subject reporting, could improve the quality of the data and adherence by subjects. Do you think this is an appropriate tool to improve quality in clinical trials? Yes or No. Explain and provided examples & reference your work to support. Provide pros and cons? What about research ethics

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Alisha

Subject nonadherence is a massive issue in clinical research. It significantly affects the quality of the research outcomes. At first glance, this appears to be a small-scale issue, but nonadherence has more severe implications in the post-market phase of the drug. The trial results determine the safety and efficacy profile for use in the patient population. If the results are skewed due to research subject nonadherence, the drug may jeopardize the safety of patients on a global scale. According to Smith (2012), nonadherence that goes unnoticed causes overestimating the drug dosage and the risk of adverse events. The risk to patients increases if the general population maintains adherence at a higher level than the clinical trial participants (Smith, 2012).

Relying on subject reporting is a standard method for discerning whether the subject is administering the treatment as instructed. However, I do realize the need for improvement. Research participants may intentionally or unintentionally skip doses yet not report it to prevent elimination from the trial, especially if there is compensation for the research subject. Are digital pills the best solution to poor adherence in clinical research? I have some doubts. The main concern is patient safety. How dangerous can the chip be if it malfunctions? Can the signal it transmits to the patch interfere with pacemakers or similar technologies? If so, is it ethical to exclude patients with pacemakers from clinical research? There is also the question of whether monitoring patients electronically is ethical. I believe it is ethical if it is thoroughly discussed and the patient is thoroughly informed about the electronic monitoring before providing informed consent.

Poor inadherence negatively affects research conduct by increasing the sample size necessary to evaluate the clinical hypotheses and prolonging the study duration (Robiner, 2004). It exposes more patients to experimental research unnecessarily. Other methods of increasing adherence, like monitoring biomarkers, exist. However, the digital pill has the potential to be more effective for ensuring compliance and comparatively less of a burden for clinical staff and patients alike.

References

Robiner, W.N. (2005). Enhancing adherence in clinical research. Contemporary Clinical Trials, 26(1), 59–77. https://doi.org/10.1016/j.cct.2004.11.015

Smith, D. L. (2012). Patient nonadherence in clinical trials: Could there be a link to postmarketing patient safety? Drug Information Journal, 46(1), 27–34. https://doi.org/10.1177/0092861511428300

Kimberly

Adherence to clinical trials has been recognized as a large issue that reoccurs resulting in nearly 50% of participants not taking the drugs correctly or at all sometimes. The use of a pill that would detect if the drug has been taken or not, would not necessarily make the study subjects take their trial drugs correctly, but it would provide investigators with more accurate data. If they were informed correctly about the subject who did take the trial drugs accordingly and who did not, they could remove the data that did not align with the procedures listed. The ingestible pill has also already been studied for safety and efficacy and has been approved by Food & Drug Administration (FDA); therefore, it has been deemed safe to use as a detection agent in humans. (Mullard, 2015)

While I do not agree this method would improve adherence, other than by way of showing participants they are always being tracked, I can agree, that this method would improve quality in clinical trials. Even if only to provide investigators a more accurate measure of which subjects to count data for and which ones to remove. The downside of this method would be the patch that matches the pill would have to be changed once a week. If a study lasts for an extended amount of time this could be a bother to participants to change. It could also result in skewed data if the patch is not changed appropriately. Overall, using this detection pill would be beneficial in order to collect more accurate data and as long as it continues to provide more efficient results of trials in a safe manner, I do believe this to be an appropriate tool to improve quality in clinical trials. (Mullard, 2015)

Works Cited

Mullard, A. (2015). Do you want chips with that? Nature Reviews Drug Discovery, 5.

Maggie

Incorporating the use of digital pills in clinical trials has both pros and cons. The use of digital pills could possibly improve quality in clinical trials, however, whether or not they should be used depends on whether or not the benefits outweigh the risks. In general, the use of technology allows the pharmaceutical industry to decrease medication errors, improve quality of care, and reduce the cost associated with adverse events due to medication errors (CADTH, 2010). I would like to say that using an ingestible chip would come with similar benefits. Specifically looking at clinical trials, this would verify subject compliance as it would accurately take note of each time the pill is ingested. This would ultimately cut out the patient having to report when or how the drug was used, ultimately eliminating any possible error due to dishonesty.

Unfortunately, there are also many cons. We need to take into consideration that this digital pill is no longer just a drug. There will be many more regulations to adhere to as this drug is in combination with a medical device. Many people may not agree with using the device and some may question if it would in any way be cancerous. There will need to be various tests performed to ensure safety. While it seems that the original chip was created a while ago, in 2012, there still may not be enough data to prove that there are no long term affects. Also, partially in relation to research ethics, there would be no sense of trust between the patient and the practitioner. Having to use a chip to ensure that the drug is being taken poses a barrier to this relationship, as it is pretty much saying that we do not trust the patient.

Taking this a step further, and looking outside of the clinical trial area, this could be helpful in other ways as well. Depending on the medication, and population that uses the medication, the patient could be forgetful. Forgetfulness could occur due to a person’s mental state, or simply due to age. This chip would prove helpful in these cases to ensure that the patient has taken his or her medication. If the medication is time sensitive, it would also keep track of when the medication was taken. This may be very helpful with drugs such as birth control, which are in some instances very time sensitive.

This could also be helpful in confirming that the patient actually took the drug and is not misusing them. For example, if a drug was made with an ingestible microchip that registered on the device each time it was ingested and kept a full report that was given to the doctor each time they prescribed the mediation, this would be proof that the drug is not being misused. There are quite a few instances where people fill prescriptions, and even refill them, and never actually take them. The drug is then wasted, which can be quite costly. On the other hand, depending on the drug, some people may fill their prescriptions and sell the pills individually on the street. While neither of these problems will be stopped due to the microchip, they may be lessened, as the doctor will then have the choice to not refill the prescription due to misuse. Personally, I disagree with using ingestible microchips as they seem hazardous and highly relatable to cancer in the near future. However, I can most certainly see how they could be extremely helpful in the pharmaceutical industry.

Reference:

Canadian Agency for Drugs and Technologies in Health (CADTH) (2010). Technologies to reduce errors in dispensing and administration of medication in hospitals: clinical and economic analyses. CADTH technology overviews, 1(3), e0116.