Medidata Patient Cloud | Patient Centric Clinical Trials (2024)

FAQs

What is patient centric clinical trials? ›

Patient-centric trials - summary

It also means involving patients in trial design, for example to ensure that trial outcomes are relevant and meaningful to patients. Patient-centric trials are designed to improve the quality of research and its relevance to patients, encouraging them to take part in trials.

Patient Cloud is a suite of powerful solutions that makes it simple and engaging for patients to participate in any clinical trial – so your trials are easier, faster, and produce better results.

In a decentralized clinical trial (DCT), some or all of a clinical trial's activities occur at locations other than a traditional clinical trial site. These alternate locations can include the participant's home, a local health care facility, or a nearby laboratory.

Regular site monitor visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits, and close-out visits. Study sites may also be monitored or audited by the FDA, Clinical Research Organizations (CROs), IRBs and sponsors.

However, the term “patient-centered” is often used to describe care that is respectful and responsive to individual patient values. “Patient-centric,” by contrast, emphasizes a more holistic view of the patient, including their role in their own care and the broader healthcare ecosystem.

Patient-centred care is also known as 'person-centred care'.

Dassault Systèmes

Dassault Systemes Americas C...

Medidata is the pioneer in Electronic Data Capture (EDC), trusted by you to run over 30,000 clinical trials, capturing data from millions of patients.

In a centralized trial, patient data is captured at set moments during in-person patient visits in a clinical environment. In a DCT, patient data is remotely collected “as it happens,” allowing patients to be studied in an unobtrusive manner in real-life situations.

What are the disadvantages of decentralized clinical trials? ›

One of the main drawbacks of decentralized trials is the lack of direct supervision from medical professionals. Doctors and nurses closely monitor patients in clinical trials performed traditionally to ensure their safety and well-being.

A GlobalData study found approximately 1,300 drug clinical trials with a virtual and/or decentralized component were expected to start in 2022, a 28% increase from 2021 (1,011 trials)) and a staggering 93% increase from 2020 (673 trials).

Subject. An individual (either a healthy volunteer or a patient volunteer) whose reactions or responses to certain interventions are evaluated during a clinical trial. May also be referred to as a trial participant.

The four main phases of clinical trials, which will be explained further below, are: Phase 1 - Assessing initial safety and dosage Phase 2 - Evaluating effectiveness and side effects Phase 3 - Confirming efficacy compared to standard treatments Phase 4 - Ongoing study of long-term effects after approval Understanding ...

The patient-centred clinical method can provide interprofessional teams with a theoretical framework for practice and a common language for communicating. dimensions of illness (feelings, ideas, effects on function and expectations). the distal context (e.g. culture, community, ecosystem).

Patient centricity was thus defined as: 'Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family'.

Patient-centricity is all about putting the patient first in everything we do, making sure their needs and preferences are at the heart of their healthcare experience. It is listening to the patient's voices and crafting a customized healthcare journey to enhance outcomes.

Patient-oriented research is about engaging patients, their caregivers, and families as partners in the research process. This engagement helps to ensure that studies focus on patient-identified priorities, which ultimately leads to better patient outcomes.