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2018/1/15 <國際職人CRC經驗分享> 從新加坡臨床試驗基地的角度看受試者收案4
Missing parameters [image]

Miao Chen, 15th January, 2018

Subject Recruitment, Looking Through the Eyes of Site…

 

I got to know Liang-Ni when she was working at the European Contract Research Organization (CRO) Singapore office. I joined the CRO just a few months after her and somehow we got along well even though we were not from the same department.

 

A few days ago, we engaged in a small talk for the first time after 6 years and she asked if I would like to write something about patient recruitment pertaining to clinical research in Singapore. She gave me the link to her past articles and I was impressed after reading her insight into drug safety/pharmacovigilance. Since it is a sharing platform, I shall not give myself too much pressure and agreed to share some of my experiences. This is why I am here. =)

 

A little bit about myself…

 

I am a Chinese, born and raised in China. I came to Singapore during my teenage year to pursue a diploma in Biotechnology at a local Polytechnic. After which, I started working in a pharmacy industry sector. At the same time, I signed up for a bachelor degree course in Pharmaceutical Management. During the course of study, the topic “Clinical Research and Regulations” interest me and I joined a CRO upon graduation. After 2 and a half years in the CRO, I joined a research institution because I prefer people contact more to desk bound job. Since then, I have been working at the research institution for 5 years. 

 

Research activities kick off once a clinical trial is awarded to the site, the main task is to assist the investigator in overall administration of clinical research activities prior to, during and post study, be it Industry Sponsored Study or Investigator Initiated Trial. Overall administration, that includes budget drafting, Ethics Committee and Regulatory submission (if any), site initiation, patient recruitment and retention, study maintenance, site closure as well as financial oversight and study administrative work etc.

 

Among all the study activities, patient recruitment poses a major challenge to many clinical trials. It is time consuming and takes up quite a percentage of the study timeline. Patient recruitment has a direct impact on whether there is sufficient sample size for data analysis, length of the study and how much time it takes for the drug to be marketed etc.

  

Singapore is a small country with a relatively small population. How to reach more target audience, raise awareness of the study and meet the proposed recruitment target, below are some points which have been commonly practiced at site.

    

  • Ø   Investigator’s referral: Investigator normally has his/her own patient pool with specific disease characteristics. They may also share with their fellow colleagues the target patient the study is looking for at their departmental meeting or external forum to increase referral volume.

 

  • Ø   Subject’s referral: Through word of mouth to spread the news around. It would be good if some brochure /leaflet with study’s basic information and site’s contact number can be given to potential subject. And yes, we do give incentives to successful referrals.

 

  • Ø   Health institution’s database: IT and Pharmacy department have been helpful when it comes to pulling out specific subject pool based on inclusion/exclusion criteria. Subject pool will then be refined through filtering. Going through each and every case can be tedious and lengthy; the main coordinator  may need an extra hand to help. 

 

  • Ø   Media support: Media definitely offers a bigger coverage but may be costly. If it is foreseen that recruitment is tough, site should budget advertisement fee in the study contract. When need be, the fund can be utilized to boost recruitment. There are many forms of media, e.g. advertisement in newspaper, posters in clinic, banners at public area (e.g. bus stop), newsfeed in website and social media (e.g. hospital webpage, Facebook etc.). Drawback for media broadcasting may be site may end up with endless calls with public enquiries.

 

  • Ø   Study Web site: There is a “Healthy Subject Registration” page on our institutional webpage which enables public to register their interest if they wish to participate in certain research study.  The information will then be transcribed to our internal volunteer database which can be retrieved if there is a suitable study in future. You may have heard of ClinicalTrials.gov, an online registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 230,000 trials from 195 countries in the world (Ref: "ClinicalTrials.gov Logo". ClinicalTrials.gov. Retrieved 22 April 2015). You may register your study with the website and we do have subjects calling in after getting to know the study from the website.

 

After having recruited the eligible subjects, next obstacle is on patient retention and ensuring the enrolled subjects complete the study per protocol specified. Study duration is getting longer, partially because regulatory requests for safety data from a longer study period to gather more information on drug safety. As site is the first point of contact for any subject related issue, hence maintaining good relationship through regular follow up phone calls, flexible study appointment and fast subject reimbursement turnaround time will encourage subjects to remain in the study.

 

Subject recruitment and retention is challenging, especially for stringent, lengthy and procedure intensive studies, at certain point, frustration is anticipated. Therefore, when investigator/site decides to take up certain study, they have to consider if the study is feasible, is there a suitable patient pool, is there sufficient resource/manpower to run the study, and not to over propose recruitment target.

 

A side note: I read Liang-Ni’s view on “Efficacy versus Safety, which comes first?”  From site’s point of view, subject safety is of utmost importance. Well-being of trial participants is something which shall not be compromised at all times. So my answer to that question is: Looking through the eyes of site, safety comes first.

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