Referring patient into clinical trials

Referring patients into clinical trials

The speed of research is accelerating. So is the need for your help.

Clinical research advances medical knowledge and improves patient care. It can contribute to the development of potential new drugs, medical devices, and procedures or diagnostic tests, and may provide insights into how diseases are caused and how they may be prevented.
Reaching the full potential in clinical research would not be possible without the dedication and involvement of the healthcare community, as well as the altruism and commitment of patient volunteers.
Advances in science and technology have greatly expanded opportunities to conduct clinical research for more disease states and more targeted treatments.
In the past twenty years, there has been a nearly 100-fold increase in the number of clinical trials registered on the ClinicalTrials.gov database (from 5,627 trials in 2000 to 450,000 trials in 2023). Most of these trials are testing potential new drugs, devices, diagnostics or procedures. These opportunities present new care options to patients with acute, chronic, oncologic and mental health conditions. As such, there is an ever-expanding need for the healthcare community to participate.

Finding trials for my patients

Numerous patients decide to volunteer for clinical trials based on the information provided by their physician. As a healthcare professional, you can encourage patients’ involvement by increasing their awareness about clinical trials, educating them on the potential benefits and risks of participation, and emphasizing the contribution of clinical trials to the advancement of medical knowledge.

There is a tremendous opportunity for the healthcare professional community to help connect patients with appropriate trials. You can look for trials on this site based on the patient’s condition and/or location. Additional information about clinical trials can be found on www.clinicaltrials.gov

The patient journey

Learn what your patients might experience in a clinical trial

Prescreening

Before a person can take part in a clinical trial, they are usually prescreened. The process enables the clinical investigator to check a patient’s eligibility based upon the trial’s defined inclusion and exclusion criteria. Thus, the prescreening stage facilitates an effective selection of the trial participants before any trial-related screening procedure is performed.

The most frequent methods of prescreening are over the telephone and online, but it can be conducted in person if potential participants find out about the trial during a medical appointment. The prescreening interview includes general questions about patients’ interest in joining the trial, their willingness and capability to attend visits, and the collection of information that may help to preliminarily assess trial eligibility, if necessary (e.g., patient weight).

Informed consent

Once a potential trial participant is identified, and they are willing to consider participating, the next step is to obtain their informed consent. To help potential participants make an informed decision about whether or not to participate, they are provided with a Participant Information Sheet (PIS). This document, which will have been reviewed by an ethics committee or Institutional Review Board (IRB) contains details about the trial rationale and aim, the intervention being tested, potential risks and benefits, and trial-related procedures. The PIS covers the information that needs to be explained and discussed with potential participants and their legal representatives, if applicable, before signing the Informed Consent Form (ICF). No trial-related procedure can be performed prior to obtaining the patient’s informed consent.

Screening

After the ICF is signed, the trial-related screening and any other procedure outlined in the trial protocol can be performed. The information collected and procedures undertaken at screening vary from one trial to another but may include: a review of the participant’s medical history, physical exam, measurement of vital signs, and specific laboratory analyses. When the screening results are available, potential participants will be informed if they are able to continue in the trial

Participant allocation to trial groups

Participants may be assigned to trial groups (controlled trials), which most often include the treatment group, in which participants receive the trial intervention, and the control group, in which participants receive the standard-of-care treatment, placebo, or no treatment. Frequently, participants are assigned at random to trial groups (randomized trials).

In most trials, participants and/or research staff are not informed of the participants’ assigned trial groups, to prevent investigator bias when reporting participants’ results (blinding). The information may be disclosed to trial participants and research staff when the trial has been completed or anytime during the trial for safety reasons. In an open-label trial, the participants and research staff know what treatment the participants receive.

Who patients may meet in a trial

Conducting a clinical trial requires a multidisciplinary team typically consisting of physicians, research nurses, and other healthcare professionals. Collectively they perform any trial-related activities, such as continuously monitoring the participant’s health and condition throughout the trial, administering the trial drug as stipulated in the protocol, performing any trial-related procedures, reporting any side effects and outcomes, and maintaining contact with the trial’s Sponsor. During their participation in the trial, patient volunteers would mostly interact with the Principal Investigator, Sub-Investigator, and Clinical Research Coordinator.

Principal Investigator (PI): Usually a physician who is responsible for running the trial in accordance with the trial protocol, keeping accurate records on implementation of the trial-related procedures and reporting any side effects of the tested intervention.

Sub-Investigator(s): Medical doctors that work in a trial under the supervision of the PI.

Clinical Research Coordinator (CRC): Involved in monitoring and evaluating trial-related activities and set-up at site level.

Clinical Research Associate (CRA): Involved in running a trial at the site to help ensure the rights and safety of participants, and that the trial follows the protocol provisions closely.

Regulatory Coordinator: Reviews trial compliance with regulations and ethical standards.

Data Coordinator: Works with trial team to collect and collate all relevant clinical research data according to the protocol.

Research Nurse(s): Offers support for trial management and may be involved in the screening of potential participants, consenting, randomization, data collection, reporting of adverse events, and preparing trial documents and reports.

Research Pharmacist: Works to support the provision of trial medication at certain visits and documents the returns of trial medication.

Trial Assistant: Provides support to the PI for trial monitoring and reporting, data management, and audits.