By Adrianne Phillips and Lyn Agostinelli, Halloran Consulting Group, Inc.
In the last decade, the life sciences industry has been standing at a crossroads when it comes to optimizing patient trust and health outcomes. With clinical trials already costing companies a fortune, stakeholders have recognized the need for patients and advocates to have a seat at the table and be the central focus in enterprise approaches, commercialization, and research and development. However, the challenges with this intention come down to cost and convenience — how can we gather as much data in as few studies as possible? And in doing this, how can we acknowledge the impact that taking part in a trial has on the patients we are working to help?
1. Walk Patients Through The Clinical Journey Early And Often
When deciding to participate in a clinical trial, patients typically don’t consider the data that is being collected from all the additional procedures they undergo. Rather, they are focused on whether the possible benefits of participation, to themselves or others, are worth the time to plan their lives around work, transportation, lodging, childcare, etc. Is taking several weeks out of your life worth having a treatment you can only get at a handful of locations? For a patient diagnosed with T1c prostate cancer, the answer may be no. For a patient diagnosed with glioblastoma, the answer may be yes. Ideally and as circumstances permit, gaining patient insight into what is important to them during the protocol development phase can help sponsors develop clinical trials that keep what is important to a patient in mind.
By walking patients through the clinical journey early on and at multiple points throughout the trial, clinicians can help patients and their loved ones anticipate what to expect at different junctures. We’ve found that this helps capture insights at different points along the treatment journey and increase transparency.
2. View The Patient Experience Holistically During Study Design
We’ve all heard the saying that “it’s the little things that make a difference.” When it comes to designing the patient experience, this statement is very much true. While there are a number of minute details involved in setting up a clinical trial, we like to advise companies to focus on taking a holistic look at the ask when determining procedures to be included in a protocol. Each procedure may not be a burden individually, but when combined with everything else the patient is asked to do, it can become overwhelming.
An example of this is pharmacokinetic (PK) blood draws that are collected at 2, 4, 8, and 12 hours post-infusion. A blood draw is not a big deal for most patients, but when there is a stringent schedule that needs to be adhered to, it can be an inconvenience for patients, especially those who have to travel far for the appointment. What will the patient do in between draws? Do they have to stay at the hospital all day? Are they able to attend to other responsibilities planned for that day?
Another example to consider is the MRI, a relatively routine procedure that patients may experience in increased frequency if mandated by the trial protocol. This requirement could require multiple visits to several clinics or health centers to complete. Will every clinical site participating in the trial have an on-site MRI? Or will the patient have to make additional appointments and travel to multiple locations? The list of questions usually builds out to include: What will be paid up front, what will be paid by the sponsor, and what will be covered by insurance?
3. Incorporate Technology To Minimize Patient Burden
With how the year 2020 has gone, the life sciences industry was forced to reevaluate the status quo and consider how to redesign clinical trials to be more patient-centric on top of what patient expectations were already — with safety as a top priority. Many sponsors have scrambled to find ways to salvage their studies and mined their networks and connections for options to securely gather clinical trial data from trials that are still active. This is where technology came into play.
Utilizing technology to execute clinical trials remotely or with limited in-person visits can, by default, make a clinical trial more patient-centric. Televisits between a clinical investigator and site staff reduce the burden of travel on the patient and allow for flexibility of the visit schedule, as a patient could arrange a visit during a break at work or in the evening. Using televisits and at-home equipment such as blood pressure and pulse oximeters has allowed patients to enroll in studies without having to leave their homes. However, not all testing can be done remotely, so sponsors are forced to ask what data they need and what data can be collected in a remote setting. Sponsors have had to explore how to conduct laboratory tests using at-home blood collection devices or by having patients collect their own nasal swab samples and arranging for couriers to pick them up. As sponsors explore the feasibility of doing this, they need to ask what they can do to get the required data while at the same time not making the clinical trial overly taxing on the patient. The burden of this challenge lies with the sponsor, as it is responsible for identifying the technology to allow for remote trials and providing oversight of new and sometimes numerous vendors.
By default, having to limit the amount of data collected to the essential and being able to work in a remote capacity brings continuity to clinical trials. There is a reduced number of patients lost to follow-up as the barriers to continuing, such as travel or numerous procedures, are removed. Patients must still feel engaged with the clinical investigator and site staff, so care must be taken during remote interactions to ensure patients feel essential and that they are contributing to something bigger than themselves. For sponsors, the continuity provides the data allowing for analysis and decision-making.
4. Solicit Patient Input On Your Study Protocol
Some patients see clinical trials as a way to possibly help themselves but, more importantly, also to help others in the future. Others see clinical trials as their only hope for treatment and will agree to anything for even the chance to be involved in the trial. As members of the healthcare community, we can’t take advantage of that desperation. Sponsors must consider the patient a partner in research and the future of their product. Even if the sponsor has designed what it feels is a patient-centric trial and made use of technology to allow for remote data collection, it must still gather feedback from the targeted patient population to determine whether the study protocol is set up to gather data realistically and in a way that makes sense for the patient going through the clinical journey. Without this crucial step, sponsors may find themselves back at square one with a trial that cannot be conducted the way it intended and, unfortunately, is not conducive to gathering the necessary data. In the end, we have to keep our patients, the force that drives the healthcare industry to continual improvement, at the center of our focus.
Given that we work in a collaborative industry, we’d like to hear from our fellow peers on how they are making trials patient-centric to answer the questions: How can we gather as much data in as few studies as possible? And in doing this, how can we be mindful to acknowledge the impact that taking part in a trial has on the patients we are working to help? Please share your thoughts in the Comments section below.
About The Authors:
Adrianne Phillips, consultant and project associate at Halloran, has a wide range of experience in clinical operations, clinical development and quality assurance. Adrianne has provided both pharma and biotech clients with project management, protocol design, quality document development, IND submission preparation and inspection readiness services and has worked across all stages of the development life cycle. Therapeutic indications have included oncology and rare disease such as ALS and Graft versus Host Disease (GvHD) with experience in bi-specifics, monoclonal antibodies and gene therapy.
Lyn Agostinelli, principal consultant at Halloran, has over 33 years’ experience in the life science industry and clinical practice as a registered nurse. She has extensive experience managing clinical programs in pharmaceutical and device companies in both industry and academic settings, as well as experience in the development and implementation of quality systems to align with best practices and applicable regulations. Agostinelli serves as an interim VP/director of clinical operations with numerous clients, working with and mentoring their personnel as they start-up and execute complex studies. She routinely works with clients on inspection readiness activities, including mock bioresearch monitoring (BIMO) audits and training on regulatory authority interaction during inspections.