Any clinical research professionals and staff members say that one of their biggest challenges when conducting a clinical trial is, obtaining a sufficient number of participants.
If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study timeline, increasing resource usage and costs. A prolonged study startup may delay a drug or treatment reach the market, extending the time, and its availability for the general public
Clinical trial market
The clinical trial market is huge and growing rapidly. A total of 2,119 active studies were registered in the year 2000 on clinicaltrials.gov and is now with 280,000 active clinical research studies. This indicates that the market’s value is multiplying and is expected to reach $65.2 billion by 2025
A report from the U.S. Department of Health and Human Services estimates that the total cost associated across all Phases of a clinical trial may range from $44 million to $115.3 million, depending on the drug’s therapeutic area. and fewer than one in 10 drugs that enter clinical trials make it to market.
Statistics of patient recruitment failures
Along with increasing clinical trial market, there are also huge hurdles in patient recruitment, here are some interesting statistics
- According to the National Institutes of Health (NIH), more than 80% of clinical trials in the United States fail to meet their patient recruitment timelines. These delays increase costs, may deplete resources, and prolong the time to enter the market.
- As much as 86% of clinical trials do not reach recruitment targets within their specified time periods
- According to an analysis of registered trials, 19% were trials were closed or terminated early because they could not accrue enough participants
- According to the FDA, only six percent of clinical trials are completed on time, and 80% of all trials are delayed at least one month because of unfulfilled enrollment.
When a clinical trial fails to recruit a sufficient number of participants, accurate conclusions cannot be drawn and even promising therapies can appear to underperform.
Patient recruitment in clinical research depends on the following factors
- Clinical trial design that can engulf more number of patients (for example unnecessary restrictive inclusion and exclusion criteria many reduce patient recruitment scope)
- Clinical investigators’ capabilities such as investigator understanding of trial requirements, number of patient visits, inexperience in the recruitment of patients for trials, etc.
- Clinical trial site reach to the number of patients, travel distances from home, patient pool available for recruitment
- Whether the trial supports Direct To Patient options, virtual sites or allow minimal site visits for patients
- Type of trials – for examples rare disease trials or cancer trials where the patient recruitment is more challenging due to fewer sites or patient population
- Timelines and budget allotted for patient recruitment and cost incurred due to trial delays, or special incentives for patients.
Strategies to improve patient recruitment
There are many theories and ideas to improve patient recruitment, but they may not provide a 100% solution, and vary with trials. However, these may help to improve the scenario to an extent.
- Complete understanding of the regulatory requirements
- Conducting clinical trial feasibility
- Building a perfect patient and stakeholders connecting strategies
- Patient-centric clinical trial protocol designs
- Applying novel and digital trends
Let’s discuss some of the strategies which are many times neglected and shall be considered more precisely to ensure enough patient recruitment and avoid clinical trial delays.
Understand the regulatory
Before designing a clinical trial, it is crucial to understand the complete regulatory requirements to conduct, complete and produce quality clinical trial data.
Various regulators have different requirements and these vary with the type of trial. For example, patient recruitment in rare diseases is a nightmare for many researchers, so many regulators such as the FDA consider adaptive methodologies in recruiting a few patients and extrapolate the safety data.
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have developed guidelines to support the design of clinical trials for small populations.
- Regulators are open to discuss the adoption of alternative methodologies and evidence sources to enhance the overall evidence base.
- The FDA furthermore encourages early communication to assist in drug evaluation, scientific, and medical questions that may arise throughout the clinical investigation.
- The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan offers advice on alternatives to traditional methodologies at face-to-face meetings during early development stages.
Develop an adequate budget for advertising, partnering (patient recruitment service providers), special patient incentives if required, cost incurred if delayed, etc,
Develop an initial recruitment budget that accounts for appropriate factors for patient outreach.
- Accentuate site activation timelines and realistic enrollment periods in resource determination.
- Plan the budget early to ensure that recruitment costs are anticipated and covered.
- Ensure a well-researched communication strategy is deployed in order to achieve efficient and effective communication and outreach.
75% of patient recruitment comes from good sites and others through various sources, and this lets you know how important is understanding the site capabilities before initiating a clinical trial, and this can be achieved by clinical trial feasibility studies.
Most of the companies start their trial without a proper understanding of the region, patient available for recruitment or investigators’ capabilities in recruiting patients
Here is where conducting clinical trial feasibility helps in minimizing these wrong assumptions and increase the probability of trial success
Conducting feasibility before initiating helps in
- Clinical investigator experience in recruiting patients and site capabilities
- Understand the timeline for study initiation, conduction, and completion of the trial
- Region pool for patient recruitment
- Site facilities
- Local ethical and regulatory requirements
- Suggestions and feedback on the trial protocol to achieve goals and desired outcomes
For a successful feasibility, it’s important to design a well-structured feasibility questionnaire to get all the answers or queries and extrapolate the likeness of the success of your clinical trial. Develop an ideal questionnaire that includes site profile, investigator experience, site capabilities, site infrastructure, institutional resources, and target population access.
Consider broadening the eligibility criteria such that it doesn’t affect the outcome of the trial but include more number of patients into the trial. Understand the complete goal of the trial and design the exclusion criteria. Develop realistic eligibility criteria
- Identify and eliminate items that are not necessary for ensuring the safety of participants.
- Eliminate items that are not directly relevant to answering the primary research question.
- Include patients in protocol planning and design
Consulting local representatives while designing a protocol is another approach to better understand patients’ needs and what are patients expecting from a clinical trial as it may vary from region to region.
Limitation of protocol complexity to reduce the burden of participation is another strategy
- Reduce procedures to those directly related to the scientific question.
- Consider the invasiveness and risks involved in the study.
- Limit activities that create additional work for sites and patients which leads to unnecessary complications.
Connect with patients
The next step in clinical trials is how to find or connect with patients. Nowadays several approaches have been developed by various companies along with traditional methods like web advertising, apps, posters in patient communities or hospitals, direct communications with patients who visit clinics.
Rare disease clinical trials involve other approaches such as rare disease communities and organizations that maintain complete patient databases along with their contact details. Such information helps researchers to directly find patients and connect with them.
Various apps have been developed and many organizations are providing special services in patient recruitment. In special cases where patient recruitment is challenging, partnering with those organizations who have better connectivity and approach with patients is wise in order to minimize trial delays.
If involving a CRO, know how they would recruit patients, what were the previous measures taken to recruit patients, and what was the success rate
Can the subject access the clinical trial site? how frequently? Can the trial allow DTP, virtual sites or minimizing the number of visitors to the site?
Choose sites that are easily accessible to patients. Some of the trials require very few site visits and can be monitored through tracking devices or through communications, and while some trials do not allow this, for example, oncology trials often require continuous infusions and nursing may be required.
- Some organizations are coming with new adaptive methods such as direct to home trials where nursing staff or physicians visit patients’ home and monitor.
- considering patient shipment service providers or consulting groups who take the patient responsibility of bringing them to the clinical trial sites
- utilizing communications such as Skype calling or video calling and monitoring digitally.
- Partnering with direct to patient and direct from patient service providers who collect the biological samples and ship to the sites or labs for testing
Information to patients
Lack of appropriate information is the biggest obstacle preventing people from enrolling in clinical trials
Conveying information through short an investigation evaluating video and audio-visual materials might help and give a clear understanding of the process and treatment methodology to the participants. this may not only help in recruitment but also in retirement. This puts a clear idea of the invasive processes involved or any untraditional method or process involved during the study.
Using an electronic approach during study startup, enrollment may reduce both patients. Understanding the language barriers is also important and simplification of language used in informed consent for are very important.
Others have looked at enhancing recruitment and retention by giving greater consideration to participant contact and convenience, financial support for patient recruiters, incentives and compensation for participation
How do you recruit patients? answer to this question has two implications one using frees sources and the second is using paid advertisements. this has to be established before starting a process.
- Develop a messaging system that resonates with the audience
- Establish your online advertising database
- Create compelling and valuable content
- Know where to put your advertising materials
Plan A should always consider free techniques such as from own website postings, post in social media like Facebook, utilizing notice boards in medical or hospital communities, utilizing patient communities data base, etc.
Next comes plan B using paid advertisements. and here are the following considerable points before initiating
- Use of online social platforms like Facebook, twitter, youtube, patient communities and forums
- Creating an online forum for participants to share experiences
- Creating shared research databases which contain target population
- Advertisements in magazines, newspapers, posters, and radio
- Using websites
- Using patient databases maintained by organizations to assess eligibility
Even after a successful recruiting method, there’s still room for participants to drop out, for which the reasons may include
- Difficulty to understand the trial procedure
- miss communication or poor understanding about the trial
- The trial’s treatment method is not the participant’s preferred method
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