Data Collection

Adaptive Studies: What Are They And How Can You Benefit From Them?

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Connie Cornejo's profile picture
Connie Cornejo
on
Feb 1, 2018

Dear Diary,

I have been struggling with an eating disorder for the past few years. I am afraid to eat and afraid I will gain weight. The fear is unjustified as I was never overweight. I have weighed the same since I was 12 years old, and I am currently nearing my 25th birthday. Yet, when I see my reflection, I see somebody who is much larger than reality.

I told my therapist that I thought I was fat. She said it was 'body dysmorphia'.
She explained this as a mental health condition where a person is apprehensive about their appearance and suggested I visit a nutritionist. She also told me that this condition was associated with other anxiety disorders and eating disorders. I did not understand what she was saying as I was in denial; I had a problem, to begin with. I wanted a solution without having to address my issues.

Upon visiting my nutritionist, he conducted an in-body scan and told me my body weight was dangerously low.

I disagreed with him.

I felt he was speaking about a different person than the person I saw in the mirror. I felt like the elephant in the room- both literally and figuratively. He then made the simple but revolutionary suggestion to keep a food diary to track what I was eating.

This was a clever way for my nutritionist and me to be on the same page. By recording all my meals, drinks, and snacks, I was able to see what I was eating versus what I was supposed to be eating. Keeping a meal diary was a powerful and non-invasive way for my nutritionist to walk in my shoes for a specific time and understand my eating (and thinking) habits.

No other methodology would have allowed my nutritionist to capture so much contextual and behavioural information on my eating patterns other than a daily detailed food diary.
However, by using a paper and pen, I often forgot (or intentionally did not enter my food entries) as I felt guilty reading what I had eaten or that I had eaten at all.

I also did not have the visual flexibility to express myself through using photos, videos, voice recordings, and screen recordings. The usage of multiple media sources would have allowed my nutritionist to observe my behaviour in real-time and gain a holistic view of my physical and emotional needs.

I confessed to my therapist my deliberate dishonesty in completing the physical food diary and why I had been reluctant to participate in the exercise. My therapist then suggested to my nutritionist and me to transition to a mobile diary study.

Whilst I used a physical diary (paper and pen), a mobile diary study app would have helped my nutritionist and me reach a common ground (and to be on the same page) sooner rather than later.

As a millennial, I wanted to feel like journaling was as easy as Tweeting or posting a picture on Instagram. But at the same time, I wanted to know that the information I  provided in a digital diary would be as safe and private as it would have been as my handwritten diary locked in my bedroom cabinet.

Further, a digital food diary study platform with push notifications would have served as a constant reminder to log in my food entries as I constantly check my phone. It would have also made the task of writing a food diary less momentous by transforming my journaling into micro-journaling by allowing me to enter one bite at a time rather than the whole day's worth of meals at once.

Mainly, the digital food diary could help collect the evidence that I was not the elephant in the room, but rather that the elephant in the room was my denied eating disorder.

Sincerely,
The elephant in the room

Adaptive studies (or adaptive clinical trials) is a relatively new term. They have been around for about 40 years; however, it wasn’t until 2004 that the FDA released the Critical Path Initiative that adaptive studies took shape. It called for more innovative designs to be used to improve study efficiencies.

Adaptive studies help decrease cost and time. By allowing for flexibility into the study, researchers may identify errors in the trial sooner and move on the right path. This adaptability is what makes the difference. By doing so, they cut the time spent on the study, and therefore, reducing costs.

In the article titled Adaptive design clinical trials: Methodology, challenges, and prospect, by Rajiv Mahajan and Kapil Gupta, they state that:

 [...] the pharmaceutical industry is gradually coming to realize that the classically structured clinical trial does not offer enough flexibility to make use of continuously emerging knowledge that is generated as the trial progresses.

 In other words, the knowledge researchers acquire throughout the trials is vast; however, the structure of the study does not allow researchers to make use of it entirely.

What are Adaptive Studies or Adaptive Clinical Trials?

Adaptive clinical trials are those that have protocol amendments, meaning one can modify them at specific points of the study. Researchers define these changes at the beginning of the study; they are not to be done at random or at any point. Investigators take the data acquired during the interim analysis and make decisions based on those results.

The greater flexibility of adaptive approaches allows investigators to address more involved clinical issues, such as patient heterogeneity, treatment scheduling, and combination therapies, in a single study.

Alexia Iasonos & John O'Quigley.

What are the critical concerns with adaptive trial/study designs?

  1. Conventional trials remain as the primary design
    Adaptive studies are a huge benefit for researchers. Nonetheless, some stick to more traditional ways of conducting their investigations. A study in which one either accepts or rejects the hypothesis stated at the beginning. This leads to black and white thinking, not recognizing there might be other paths or even better ones. Adaptive studies allow for modifications and give flexibility to the study. Besides, with adaptive studies, one can test many treatment arms simultaneously, unlike with conventional trials. Proffering adaptive studies the advantage.

  2. Adaptive study designs require constant adaptations
    A frequent use case is dose-finding (finding the proper dose administered). The treatment is a variable continually changing and being adapted to test the minimum dose required for the drug to affect, and the maximum tolerable dose. This means the data monitoring committee needs to meet regularly to make the proper adaptations. Without the appropriate EDC, this could not happen.

  3. Adaptive designs may cause bias
    In adaptive designs, researchers may analyze, and in fact are encouraged to, interpret data during the interim analysis. The knowledge of early data is what is so great about adaptive designs, it does, however, give space for bias. Since researchers know the trends of the study, they adopt the plan the best they can with those results. This may be a problem since they are now biased towards the research. By analyzing the data so early, researchers can now influence the remainder of the trial. That is why an early open discussion is so important, as well as following the FDA and EMEA’s approach, to reduce the bias as much as possible.

How does Teamscope make it more accessible?

Real-time data analysis

Having data analysis in real-time is crucial. According to Mahajan and Gupta:

[...] quick and reliable electronic data collection would seem to be mandatory for a trial that is dependent on constant updating.

As the trials take place, new knowledge is acquired, and therefore further theories arise. Being able to have that information allows for time optimization and, therefore, a decrease in costs.

Teamscope allows for powerful graphs

The ability to use graphs as the study progresses is incredibly beneficial. Data required throughout the research is essential. The use of charts can help the study as a visual aid as well as an immediate source of results.

Conclusion

Adaptive studies are beneficial for clinical trials; however, many researchers are reluctant and chose more conventional designs over the new more innovative ones. One of the reasons this happens is the constant need for adjustments in adaptive studies. Without the proper platform, these adaptations would be very complicated to make. EDC’s such as Teamscope not only make this a possibility but also make it an easy task. Another reason some researchers chose the traditional designs is the difficulty interpreting data. Teamscope’s real-time data analysis provides researchers on-demand access to statistical analysis, allowing them to have the visibility over the insights that an adaptive workflow requires.



References:

  1. Gottlieb K. (2016) The FDA adaptive trial design guidance in a nutshell - A review in Q&A format for decision makers. PeerJ Preprints 4:e1825v1https://doi.org/10.7287/peerj.preprints.1825v1
  2. Mahajan, R., & Gupta, K. (2010). Adaptive design clinical trials: Methodology, challenges and prospect. Indian Journal of Pharmacology42(4), 201–207. http://doi.org/10.4103/0253-7613.68417
  3. Adaptive clinical trial. (2017, September 23). In Wikipedia, The Free Encyclopedia. Retrieved 20:18, February 1, 2018, from https://en.wikipedia.org/w/index.php?title=Adaptive_clinical_trial&oldid=802022701
  4. Iasonos, A., & O’Quigley, J. (2014). Adaptive Dose-Finding Studies: A Review of Model-Guided Phase I Clinical Trials. Journal of Clinical Oncology32(23), 2505–2511. http://doi.org/10.1200/JCO.2013.54.6051
  5. FDA (2010). Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics.

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Dear Digital Diary,

I realized that there is an unquestionable comfort in being misunderstood. For to be understood, one must peel off all the emotional layers and be exposed.

This requires both vulnerability and strength. I guess by using a physical diary (a paper and a pen), I never felt like what I was saying was analyzed or judged. But I also never thought I was understood.

Paper does not talk back.Using a daily digital diary has required emotional strength. It has required the need to trust and the need to provide information to be helped and understood.

Using a daily diary has needed less time and effort than a physical diary as I am prompted to interact through mobile notifications. I also no longer relay information from memory, but rather the medical or personal insights I enter are real-time behaviours and experiences.

The interaction is more organic. I also must confess this technology has allowed me to see patterns in my behaviour that I would have otherwise never noticed. I trust that the data I enter is safe as it is password protected. I also trust that I am safe because my doctor and nutritionist can view my records in real-time.

Also, with the data entered being more objective and diverse through pictures and voice recordings, my treatment plan has been better suited to my needs.

Sincerely,
No more elephants in this room

Connie Cornejo's profile picture

Connie Cornejo

Marketing Manager at Teamscope

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