The processes involved in patient recruitment and retention constitute some of the most critical aspects of successfully initiating clinical trials and maintaining the integrity of its data.
Both historically and in the current landscape, an alarmingly high percentage of clinical trials tend to fail or be prematurely discontinued due to the lack of adequate patient recruitment and retention. The Lasagna’s Law states that “the number of patients available to join a trial drop by 90% the day the trial begins. They re-appear as soon as the study is over”. Regrettably, not much has changed since this concept was first introduced by Dr. Lasagna over 40 years ago.
We at Cromos Pharma are fully aware of these challenges and are highly dedicated to delivering consistent and favorable results to all our clients.
Cromos Pharma has been able to enroll patients either on time or ahead of schedule in 95% of its clinical trials.
We have been able to accomplish this by constantly adapting to the ever-changing landscape, continuously keeping up with industry trends and scientific research regarding patient recruitment and retention rates, and incorporating relevant insights, information, and guidance into our practice.
It All Starts with Medical Writing
The relevant research suggests that the poor quality of medical writing is one of the leading factors that stand in the way of achieving and maintaining adequate patient recruitment and retention rates.
Poorly written clinical trial protocols, investigator’s brochures, promotional and educational materials, and patient consent forms make it difficult for the investigators to adequately comprehend and subsequently communicate to potential participants the goals, risks, benefits, and procedures involved in a clinical trial.
This has a detrimental effect on health literacy rates amongst both the potential participants and the investigators, which in turn leads to lower rates of patient recruitment and higher rates of patients prematurely dropping out of clinical trials.
Fortunately, Cromos Pharma has an outstanding team of medical writers at its disposal, consisting of highly qualified individuals who have extensive experience in writing clinical trial protocols, investigator’s brochures, patient consent forms, and other relevant materials including but not limited to:
Cromos Pharma understands that an appropriate degree of collaboration and coordination between Clinical Research Organizations and Clinical Trial Sites is vital in ensuring that all the potential issues related to the processes involved in patient recruitment and retention are handled in an appropriate, timely, and professional manner and in accordance with the relevant laws and regulations.
For this reason, whenever necessary, Cromos Pharma schedules and conducts face-to-face booster visits, which are attended by the members of the clinical trial site personnel who are directly involved in patient recruitment and retention processes.
Booster visits: Whenever the need arises, we schedule additional face-to-face meetings with all clinical trial site team members.
One of the approaches that gives Cromos Pharma an advantage over its competitors is active collaboration with a vast network of clinicians and medical facilities that can be engaged as referral sites. These sites perform patient prescreening and refer patients to PIs involved in the trial. Such broadening of patient pool in hard-to-recruit trials allows Cromos Pharma to enroll patients 2-3 times faster compared to the industry average.
Referral sites: We have our own database of medical providers (outpatient facilities, private hospitals, regional hospitals) with whom we sign agreements to refer patients for participation in clinical trials.
Cromos Pharma has developed and utilizes an effective system of direct-to-consumer (DTC) outreach with the goal of maximizing the volume of relevant information being imparted to the potential participants about various aspects of clinical trials for reasons related to patient literacy, which in turn minimizes the chances of such participants prematurely dropping out of clinical trials, thus increasing the patient retention rates.
Cromos Pharma’s DTC outreach program is also highly effective in terms of advertising and raising awareness about various clinical trials, attracting the attention of potential participants and physicians alike.
DTC outreach: We assist Investigators in increasing the awareness among potential participants of clinical trials by organizing seminars for participants and their families to familiarize them with the clinical trial process and educating them on how such research contributes to the development of new treatments. We additionally assist Investigators in the business of digital marketing, website, social media, explainer videos, and mobile applications, which are all critical tools in ensuring that both clinicians and patients become aware of relevant studies.
Cromos Pharma is also mindful of how logistical and financial issues on the part of the potential participant, specifically the issues related to access and transportation, may impact patient recruitment and retention rates.
Accordingly, Cromos Pharma has developed and implemented appropriate reimbursement plans to ensure that we can tap into the pool of potential subjects who would otherwise not be able to participate in clinical trials due to financial or logistical reasons.
Commitment to patients: We have created robust reimbursement procedures (taxi, accommodations, meal vouchers) for enrolled patients.
Protecting health and safety of trial participants is extremely important to us at Cromos Pharma. We exercise extreme diligence in our approach to site selection and to choosing Investigators. While most companies face challenges in subject recruitment and retention, Cromos Pharma is consistently on track when it comes to achieving the “Last Patient In” target. Our key focus is on maintaining our extensive professional network, which has consistently delivered patients supportive of the clinical trial research process.
By analyzing study population, sites’ motivation to enroll, type of disease, and subjects’ barriers to participation (e.g., travel distances, number of visits, etc.), we have developed a proprietary algorithm that facilitates identification, recruitment, and retention of the precise type of patients needed for the successful trial conduct.
Finally, Cromos Pharma engages its feasibility team during the startup phase of each trial. By doing this, the knowledge gained during the feasibility process is shared and transferred efficiently to the clinical operations team. This ensures effective launch and subsequent conduct of every clinical program.
The challenges and factors involved in patient recruitment and retention are relatively complex and multi-faceted.
Failure to take all of these factors into account could lead to delays in patient recruitment, and in initiation of a clinical trial, which could potentially cost you or your company millions of dollars in lost revenue which is why choosing the right CRO for your clinical trial is of utmost importance.
By making the decision to work with Cromos Pharma, you can rest assured and be confident that an adequate number and appropriate types of patients will be recruited, enrolled, and maintained within the scope of your proposed clinical trial in a timely and professional manner.
If you wish to learn more about Cromos Pharma’s practices in relation to patient recruitment and about our proprietary risk-sharing program, please visit the following page – “No Patients – No Payment”.
To learn more about how Cromos Pharma can help you or your company achieve your desired goals and what other services Cromos Pharma has to offer, please visit the following page – “Clinical Research Services”.
If you are interested in finding out more about the various factors and potential difficulties involved in the patient recruitment process, how to overcome these difficulties, and what you can do to improve the rates of patient recruitment for your clinical trial, we encourage you to read one of our publications about this topic – “How To Improve Patient Recruitment in Clinical Trials”.
Cromos Pharma has over 18 years of experience in managing all aspects of clinical trials across a range of therapeutic areas. With operations in the US, Central and Eastern Europe we combine global expertise with profound local market knowledge to deliver end to end solutions supporting our pharma and biotech clients.