The way clinical trials are being conducted needs to change. If the patient’s perspectives, expectations, fears and doubts are not being addressed, then clinical trials can never fully become successful. All stakeholders involved in the clinical trial must align all decisions with the patient’s wants, needs and preferences. Information about the trial, the process, the people involved all need to be channeled through the patient. If we want patients to be committed to the clinical trials, then we need to commit to engaging and empowering the patients before, during and after the clinical trial.
Imagine a future with happy patients, high recruitment and low dropout rates. The typical clinical trial of the future incorporates patient perspectives. The focus is centered on the patient and less on the trial.
Mr. Peter Kelly is 48 years old, and works as a Sales Representative for a computer firm. He is married, and a proud dad of three teenagers. For several weeks, Peter realized changes in his bowel habits. At first, he didn’t think much of it, until he saw changes in the consistency of his stool. He decided that it was time to visit his physician. Peter has been rather stressed out the past five months because of all the preparation around the launch of a new computer software system. His wife Mary made a call to their physician and scheduled an appointment.
General Practitioner’s Visit
Peter’s physician Dr. Snow processed the symptoms described by Peter in the PCTS (Patient Clinical Trial System). The PCTS automatically conducts a search for clinical trials based on Dr Snow’s input. Without having a final diagnosis for Peter’s symptoms, Dr. Snow is aware of clinical trials being conducted in relation to his symptoms. As a diagnosis is yet to be made, Dr. Snow conducted a search within Heppsville County. If necessary, and depending on Peter’s wishes, he can broaden the search. Dr. Snow and Peter discuss several possible tests based on the symptoms. They decide on a colonoscopy as the best next step.
Mary accompanies Peter to the Charles H. Fields Hospital where his colonoscopy is scheduled to take place. They are both quite nervous, but feel confident about the medical team. The evening before the colonoscopy they could send last minute questions they had to the Information Request System of the Charles H. Fields Hospital.
After the colonoscopy, specialist Dr. Heather discussed her initial findings with Peter and Mary. They are both devastated. Cancer! They are introduced to Stan, one of Heppsville’s Oncology Support team members. Stan’s main task is to offer support to both Peter and Mary and guide them through the challenging weeks they have ahead. Dr. Heather adds her findings to the PCTS, which narrows down the clinical trials based on this input. Once the final diagnosis is in, Dr. Heather, Stan and Dr. Snow prepare a list of the clinical trials available to Peter.
Once Peter and Mary decide on a clinical trial, they are introduced to the clinical trial team involved in that specific study. This introduction is done through the PCTS system, at least one face-to-face meeting, and video chat sessions with the Study Manager. Each team member profile is available to Peter and Mary through the PCTS system. After logging in to his personalized PCTS account, Peter can send messages to individual team members or the whole team.
Peter feels very much at ease knowing that if he wanted to, he can plan a video session with his manager through the system. His manager is just one click away to answer questions, supply him with information, or reassure him when necessary. Peter doesn’t have to keep Mary up to date on the ins and outs, appointments, the treatment, or any other treatment-related issues. This is all taken care of by him adding Mary to his PCTS account as a caregiver. Mary is also able to post questions to the team or a specific team member. Peter knows that he can restrict the information Mary is able to access if he ever feels the need to do so.
Peter feels confident and ready to proceed with the trial. His questions have been addressed and answered as best as possible. During the trial the team is available at his fingertips. He can post his questions through the PCTS system, request and even book an appointment if ever he feels the need to speak to someone. Peter feels safe knowing the clinical trial he is about to start has been tailored to fit his wants, needs and preferences. He can count on Mary’s full support during the trial. Mary has been able to follow the entire process leading up to this moment – the start of the trial.
Peter is able to access information on upcoming appointments, post questions and remarks to specific team members involved in the trial or to the entire group. Through the PCTS system Dr. Snow, Peter’s General Practitioner has been keeping track of any side effects Peter might be having. The clinical trial team members all have access to the same information. Any changes made to the data becomes available real-time for everyone.
Trial Close-Out and Post Trial
Peter and Mary decided to throw a party to celebrate the end of the trial. Peter feels lucky. The trial has proven successful. He looks forward to some closure and can hardly wait to return full time to his job as a Sales Representative. The team has been instrumental in accommodating Peter during the trial, making sure it did not interfere with his personal life. As Peter often put it: ‘The team made it easy for me to participate on the trial, while I carried on with my life.’
The team members all sign off on the Close-Out Checklist in the PCTS system. Thereafter, all members receive the following email: Close-Out Patient Checklist ‘closed’ by Peter Kelly; Date – July 11, 2019; Time – 03:00 PM.
Patient-Centric Trials of the Future
Patient-centric trials can be achieved by engaging and empowering patients. Clinical trials are not only for the patients, but about the patients. Their success depends on having a patient-centric approach. It’s about aligning all decisions with the patient’s wants, needs and preferences.
Engaging and empowering patients requires improving communications with them. We must bring together the culture of medicine and the aspects which make up a patient’s value systems. These values may be based on ethnic heritage, nationality, age, religion, sexual orientation, disability, or socioeconomic status.
To quote Siegfried Meryn, who put it eloquently: “What patients want is to receive information about their problem, and the outcome, more openness about the side effects of treatment, relief of pain and emotional distress, and advice on what they can do for themselves.”
‘Improving Doctor-Patient Communication’ – Siegfried Meryn, Professor of Internal Medicine