For Patients

Finding the right treatment for your condition or symptom can be challenging. Personalized Trials can help you learn more about which treatment is best for you. Below, you can learn more about what participating in Personalized Trials is all about.

For Patients


  • Improves your medical care
    • Identifies best evidenced-based, optimized, personalized treatment
    • Provides direct health benefit to patient
    • Results are immediately known
  • Enhances opportunity to participate in research
    • Customized inclusion criteria
    • Promotes science to benefit self and community
  • Improves clinician-patient relationship
    • Facilitates communication with provider
    • Validates patient feedback
    • Makes patients feel uniquely cared for
  • Enhances patient engagement in care
    • Increases knowledge of own condition, treatment and treatment side-effects
    • Increases sense of autonomy
Kravitz RL, Duan N, editors, and the DEcIDE Methods Center N-of-1 Guidance Panel (Duan N, Eslick I, Gabler NB, Kaplan HC, Kravitz RL, Larson EB, Pace WD, Schmid CH, Sim I, Vohra S). Design and Implementation of N-of-1 Trials: A User’s Guide. AHRQ Publication No. 13(14)-EHC122-EF. Rockville, M Agency for Healthcare Research and Quality; 2014.
Kronish IM, Alcantara C, Duer-Hefele J, St Onge T, Davidson KW, Carter EJ, et al. Patients and primary care providers identify opportunities for personalized (N-of-1) trials in the mobile health era. J Clin Epidemiol. 2017 Jun 23 [Epub ahead of print].


“I kind of like that approach (N of 1) because I think it would empower me to really sense how the treatment is affecting my body. And I think that would be very beneficial, being responsible for my own health”

Patient Participant D


“I have this feeling that this is a more patient involved, patient powered, if you will, type of interaction doing research and I’m all for that….just the idea of bringing science and patients together, I think it is a tremendous idea”

Patient Participant F


“I think individuals trials will be good because in the long run what could help me could also help you, or that person could help me”

Patient Participant B


“We are not all the same, even if we’ve got the same diseases, we’re all different. Just
because something works for you, doesn’t me than it’s going to work for anybody else”

Patient Participant E


“If I could be in a clinical trial, and still be in my hometown with my own doctor, I don’t see why I wouldn’t be willing to participate. For me, it’s a win-win”

Patient Participant D


“…the advantage obviously is that it’s an individual study. So the doctors and staff areonly concentrated on you instead of all these other people.”

Patient Participant A


“What we tend to do is search for clinical trials that we might fit into. If they were
patient-driven then we can design them around what our needs are.”

Patient Participant K


What is a conventional randomized control trial?

Conventional randomized trials compare the effect of treatments (or treatment versus control) across groups of patients. Most clinical trials are typically conducted by enrolling a large number of patients. Patients are assigned to one of two or more groups which compare different treatments or medication for the same condition. In the end, success is measured by comparing how the groups respond to the different treatments. The results can help clinicians and patients to decide together which treatments are worth trying.

For example, in this kind of trial

  • Among a group of patients experiencing pain, half might be randomly assigned to take Tylenol while the other half takes Motrin for 2 weeks.
  • Then, at the end of 2 weeks, the two groups would be compared to learn which group’s pain was reduced the most, the Tylenol group or the Motrin group
  • The results can help doctors know which treatment works the best for people who are similar to the types of people enrolled in the clinical research trial
Where did the name “Personalized Trials” come from?

A different research approach is called Personalized Trials, also known as N-of-1 trials or patient-as-their-own-control or single case studies. This name came from statisticians because this trial focuses on one patient—the one patient who is trying to decide with their provider the best treatment for that one patient. In Personalized Trials, an individual patient decides on the treatments he/she would like to know about, and then is assigned to receive a sequence of treatments in a random order.

What are the steps for conducting Personalized Trials?

A patient in this kind of trial might receive Treatment A for 2 weeks, followed by Treatment B for 2 weeks. Often, neither the patient and nor the provider know which treatment that patient is receiving first and which one second. Throughout the trial, the patient is closely monitored and at the end of the trial, the treatment “code” is broken, the patient and the care provider jointly review the results to see if the patient did better with A or B, and they then decide which one would be best for that patient. In this type of trial, an individual patient is given the opportunity to test two or more treatments, often in a random order.

Steps for conducting Personalized Trials using hypertension as an example


Step 1: Choose the Personalized Trials design

  • Decide with your doctor which blood pressure medications you want to compare
  • You can also consider comparing medications to a lifestyle option (i.e., low salt diet) or compare 2 lifestyle options

Step 2: Treatment Tracking

  • Track the effects of two or more blood pressure medications by measuring your blood pressure with a home blood pressure device twice per day
  • Track whether you are experiencing any side effects at the end of each day using an electronic diary

Step 3: Data visualization and analysis

  • Review data summarizing the effects of each blood pressure medication on your blood pressure and on side-effects

Step 4: Shared decision making

  • Decide with your doctor to see which blood pressure medication works best for you by going through the checklist
What is blinding?

Blinding is when information about the treatment is masked (kept) from the participant and/or provider, to reduce or eliminate bias, until after a trial outcome is known. For example, patients may be more likely to think a brand name drug is more effective than a generic drug based on subliminal messaging, marketing or individual biases. Masking which drug you are taking might allow for a more scientific, objective assessment of treatment effects.

What is a washout period?

A washout period is a period of time during a trial when a participant is taken off of a drug or treatment in order to eliminate the effects of the treatment.

What would Personalized Trials for pain look like (e.g., Motrin vs. Tylenol)?

  • A single patient who is experiencing pain might receive Tylenol for 2 weeks, followed by Motrin for 2 weeks, followed by Tylenol for another 2 weeks
  • Throughout the trial, the patient monitors the effects of the treatment
  • At the end of the trial, the patient and the doctor jointly review the results to see if the patient had less pain or side effects with Tylenol or Motrin
  • With this information, the patient can then decide with their doctor on which treatment is best for them. These patients may learn that the treatment that is best for them is different than the treatment that is best for other patients
How much of a role can I play in the design and conduct of my Personalized Trials?

Personalized Trials can be conducted with varying levels of individual involvement. For example, in some Personalized Trials, you can select the types of treatments they wish to compare, the duration of the trial, and the outcomes you would like to use to compare the effects of treatments (e.g., side effects).

Patients can directly review the data obtained from the Personalized Trials and share in the decision-making with their clinician around choosing preferred treatments. Some patients prefer that their personal clinicians use the data from the Personalized Trials to arrive at treatment decisions with minimal patient input.

How Can I get Involved?

Researchers at Columbia University Medical Center are conducting Personalized Trials for symptoms and conditions such as fatigue, high blood pressure, insomnia and chronic pain. If you’d like to receive more information about these studies, please click here.