Still Waiting on A Medical Breakthrough? Clinical Trial Recruitment Efforts Could Be to Blame.
Hope. It is a phrase often used in conjunction with cure for a disease and conditions, a promising positive outlook that one day, a cure will be found for a disease or condition.
However, for many investigational products that moment of hope may never come. Efforts to get participants enrolled in clinical trials—a necessary part of each product approval that tests the product for safety and efficacy—often fall shorts, delaying or halting entirely the drug development process.
The difficulties surrounding recruiting patients into clinical trials are growing even faster than the startling need for clinical trials participants. The scale of the need is remarkable:
- Recruitment accounts for roughly 30% of the clinical trial timeline. (Applied Clinical Trials)
- Patient recruitment delays trials to double the planned timelines. (nRollmed)
- 15 – 20% of trials never enroll a single patient. (Pharmaceutical-Technology.com)
- Close to 85% of all neurologic clinical trials are delayed due to recruitment difficulties and 30% fail to recruit a single subject. (Huffington Post)
- In any given trial, 11% of sites fail to enroll a single patient and 37% under enroll. (George Washington University)
- Roughly 3 percent of all cancer patients in the United States ever agree to join a trial. Among women and many minorities, the participation rates are even lower. (New York Times)
For patients, it becomes more frustrating: 85% of patients reported that they were unsure or unaware that there was a clinical trial option at the time of their diagnosis, and if they had known, 75% of these patients said they would have been willing to enroll if they knew it was possible.
Investigators want participants. Participants are willing to enroll but aren’t aware or don’t know how. Manufacturers spend millions on recruiting efforts that fail to recruit the desired number of patients.
The Need for a Patient-Centric Approach
To date, the most tried and true method for obtaining trial participants is by identifying qualified patients using medical records, hospital -based registries or online databases. Beyond this, the various strategies that involve communications with patients or physicians fall short of expectations. This is the crux of the problem: the communications that are being sent to patients are clinical and lacks a patient-focused tone. The result of the jargon filled content excludes the patient even if they are aware of the scientific roots and terms of their condition. It is more by chance that patients are match to potential trials, rather than any focused effort.
The cold, scientific nature of the online portrayal of the clinical trial and participation does nothing to alter the long-established, poor reputation and institutional fear of clinical trials. The fears that the medicine will do more harm than good, that the process will be painful and difficult, that if it works it will be taken away or that they will only receive a placebo for potential life-saving cures are in no way addressed or discussed with the patient.
A patient-centric approach would address each of these fears at every entry and information point to demonstrate not just the altruistic benefit, but also the potential medical benefits (to the point allowed by law).
Even so, the need for the patient-centric approach goes beyond researching. Improvements are needed to detail how the process works from the viewpoint of the patient instead of the scientific participant.
The Internet Information Impact on Medical Options
The impact of patient-centric medical information from online credible sources such as WebMd®, the Mayo Clinic and others easily found via search has allowed patients to become more knowledgeable and research their medical diagnosis and care options. It is no longer uncommon for a patient to approach their medical providers with reams of printouts related to their condition providing their physician with information they may be unaware. This easy access to information, increased participation in their own care options, and the overwhelming scale of the information, available means that it should be assumed that the patient is the one searching for trials that may assist their outcomes and not solely their physician. In fact, the internet and the media are the top sources for clinical trial information with more than 46% of patients receiving information from the internet.
It is to this environment that the clinical trials recruitment efforts must rapidly evolve its patient-centric model to attract and educate the patient who will then approach their medical community to evaluate application and subsequent participation in clinical trials.
Adding a Trusted Source: Patient Advocacy Groups
Around 25% of the public prefer to receive clinical research information from pharmacists and advocacy groups but only 8 – 11% actual do. Organizations such as the Michael J. Fox Foundation promote clinical trials as a tenant of their education efforts. To date, they have received more than 68,000 volunteers in their Fox Trial Finder®. Organizations with a disease or condition focus can help lessen the burden to their members and provide similar tools to help match patients. This trusted voice will create an immediate sense of connection and patient first approach that is so needed in recruitment effors.
Addressing the Hurdles to a Patient-Centric Approach
One of the major hurdles to the patient-centric approach is the need for the legal teams providing oversight to participate in the process to enable changes to the current structures rather than the immediate or traditional responses to limiting all content to the sterile message. The legal considerations are by no means trivial nor unwarranted. They do not though have to be completely prohibitive to an alternate approach.
Even those clinical trials recruitment efforts that aim to focus on the patient fall short and instead rely on the scientific need for the participation with cold statements packed with medical jargon. This places the medical practitioner at the front line of the recruiting effort rather than the patient.
No one is arguing that patient selection and participation must be backed by science and the participation of the practitioner. However, the patient needs to be enabled and perceived at the onset as the focal point – not the pure medical science. The purely medical model is utilized for reasons beyond the legal requirements and legal involvement in relating the lack of guarantees and risk potential. This model comes to the forefront as clinical trials remain tied to the core model of the medical profession as mysterious and godlike practitioners and scientists who must be the gateway to patient care. However, the medical world is finding that it must move away from this model of the medical professional as the bastion of care to one where the patient and their caregivers are intimately involved in their own medical options. Clinical trails participation is moving away from this model as during clinical trials the patients are treated with personal care and understanding. The same level of human understanding needs to be transferred to the recruitment model.
How to Make the Change
While there’s no silver bullet, there are several ways organizations can begin to change this paradigm:
- Acknowledge: Companies recruitment and legal teams should clearly acknowledge that the advancements being made for the benefit of patient outcomes must utilize an approach that raises the patients’ overall well-being beyond the scientific need
- Revise: Update recruitment strategies that maintain quality and standards, but encourages a patient-centric approach that promotes awareness and works with trusted leaders
- Step-Up: Patient advocate groups should be at the core of the recruitment effort collaborating with the investigators that are working to find cures for the conditions they support.
Read more regarding the issues related to clinical trials recruitment:
- Forte - "Why Do Recruitment Efforts Fail to Enroll Enough Patients?"
- New York Times - "Clinical Trials Need Cancer Patients"
- Clinfield - "Facing the challenges of recruitment to clinical trials"
- UC San Francisco - "Recruiting Clinical Trials Participants"
- UC Davis - "Effective Strategies for Patient Recruitment"