Introduction

PKB collaborates with Clinical Research Organisations (CROs) to offer a cost-effective and efficient solution to support patient recruitment and retention for clinical trials.

CROs are able to define criteria such as diagnosis and gender, among others, and PKB’s patient activation engine will then match and present potentially eligible patients with relevant trials. 

With patient authorisation, CROs can access verified coded data via PKB that can be seamlessly extracted into their clinical trial systems via PKB's FHIR APIs. 

Additionally, PKB provides interactive tools such as questionnaires to verify patient eligibility criteria and individualised care plans to enhance participant retention and keep patients engaged and informed throughout the clinical trial process. Keep reading to find out more.

Workflow

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Why choose PKB

CROs can struggle to identify eligible patients to participate in research trials or innovative treatments that could be life-changing or life-saving. Traditional models rely on clinicians manually identifying potential patients by sharing their health records with trial companies, which is a slow, back-and-forth process.

Through the PKB platform, patients are matched to clinical trials based on eligibility criteria set by CROs. They are notified within the platform about relevant trial opportunities and can review the details before choosing to share their records with the CRO via PKB.

What

PKB can be used by CROs to identify and connect patients with relevant clinical research trials based on customisable criteria such as age, gender, and medical conditions. Both inclusion and exclusion criteria can be entered into PKB to narrow down and target the most suitable patients to be offered the trial in each case. Patient data remains securely within PKB and is only shared once the patient opts into the trial. 

How PKB optimises clinical trial recruitment

PKB empowers CROs to expand the reach of their clinical trials by connecting appropriate patients with relevant opportunities. The CRO needs to provide PKB with specific selection criteria to feed into the activation engine. The software then matches potential eligible patients with the relevant trials based on their medical records, displaying trial opportunities to the patient directly within their PKB record without requiring the patient to share their data outside of the platform to see this opportunity.

Once a patient has decided to find out more and ‘opt-in’ to a trial, they will share their data with the CRO. The CROs can then use the validated data in PKB to confirm if the patient is eligible.

This process enables CROs to optimise clinical trial recruitment by:

• Identifying suitable patients within seconds

• Engaging patients directly through their PKB record

• Informing patients of potential trials 

• Streamlining the consent process 

• Enhancing the validation process

• Enabling remote and virtual trials 

• Improving data collection and tracking

Benefits of PKB

Simplifies patient recruitment

• Patients can be notified of and opt into research and clinical trials via the PKB platform and grant consent through the simple team registration process. 

Improved patient retention 

• Clinical trial providers can share key documents such as trial processes and expectations, via PKB.

• PKB questionnaires and care plans can be used to verify data, collect further information, track progress, and provide support and advice. 

Better access to data

• Access to GP data, patient demographics, diagnoses, medications, allergies, vaccinations and documents, and appointments across England for citizens over the age of 16 where their GP has enabled online services.

• FHIR API integration allows data from records to be easily extracted and accessed in one place, improving efficiency.

• Reduces the inconsistencies of paper-based records.

• Access to secondary, social, community, voluntary, private, and mental health care data within England is available if the patient is treated by another organisation that uses PKB.

Better access to patient-added data 

• Digital questionnaires, measurement data, symptom tracking, and tests with patient input data via PKB or the NHS App.

How PKB supports participant retention

Clinical trials can sometimes take years to complete, requiring participants to check in, complete questionnaires, and track progress regularly. PKB facilitates virtual interactions, which can enhance data collection and participant retention.

• Continuous patient engagement - participants remain informed and engaged through secure messaging, questionnaires, personalised care plans, and library resources. 

• Remote monitoring - with symptom tracking, digital questionnaires, and virtual appointments, reducing in-person appointments. 

• Secure communication - CROs can send updates and messages via PKB’s asynchronous messaging. 

• Reduced burden -  reduce in-person visits by enabling digital interactions and remote monitoring, ideal for long-distance trials.

• Real-time data -  early intervention through access of patient-reported data to prevent dropouts.

• Participant empowerment -  people can track their progress, fostering a sense of involvement and commitment. 

Key PKB features

PKB Library 

• Resource of information for patients pre, during and post-trial 

• Videos, links, generic health information and resources

• Information about the trial and services

• Q&A documents

• Informed consent information

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Care plans 

PKB’s shared care plans are unique, as anyone accessing the patient's record can co-create and co-edit. They provide direction for personalised care by:

• Providing information and advice

• Educational materials 

• Signposting 

• Medication dosage, adherence, tracking and monitoring  

• Symptom monitoring and tracking

• Informed consent 

Digital Questionnaires

CROs can use questionnaires to record clinical review outcomes, identify patients suitable for clinical trials, and keep in touch with them throughout the trial. 

PKB's advanced questionnaire features include scoring and calculations, branching, coded field mapping to clinical codes, draft saving, and the ability to send questionnaires at any stage of recruitment. 

Coded questionnaire responses are mapped to the patient's graphed measurement section to track trends and progress over time.

 

 

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Messaging

Both during and post-trial, PKB messaging can be used to communicate with patients.

Patients have access to message the trial team with any questions or concerns (saving time on the phone)

Further Information

• Guidelines for clinical trials banner

• PKB Manual Clinical Trials explainer page for patients