By Soon Wen Xian
Soon Wen Xian, a medical graduate of Volgograd State Medical University, is currently a Clinical Research Associate at an international pharmaceutical organization based in Malaysia.
When I was a young boy, Sabah and Sarawak have always had an air of mystery about it. Despite both being the largest and second largest state in Malaysia, I never had a chance to visit them. And that was until I joined the clinical research industry.
In 2016, one of the clinical trials which I handled involved two sites from Sarawak, namely Hospital Umum Sarawak and Hospital Miri. The trial is a Phase 2 trial which involves intensive pharmacokinetic (PK) sample collection. The collection can be up to 6 samples within 12 hours in a day. In view of the nature of the trial, the sites are to collect nasal swab and process it with PCR machine to determine its eligibility. Besides this, scheduled on-site visits are very close and each visit requires collection of PK samples, nasal swab and nasal swab samples which subjects did it themselves at home. These arduous procedures were discussed during pre-trial assessment visits and both sites showed very positive attitude in taking up the challenge. Sites were very effective during the submission process to the ethics committee and regulatory agency. All site staff attended the site initiation meetings, trainings were completed on the same day and all signatures were collected on the spot.
Unfortunately, the sites were opened in December when Christmas, New Year and the Chinese New Year celebrations were around the corner. Malaysia was selected as the rescue site for this trial. To exacerbate the matter, recruitment period was shortened resulting in the sites having only two months to recruit subjects. Once the site was opened, investigators started actively screening for potential subjects and both sites managed to randomize their first subject within 3 weeks.
Randomization is just the beginning. The next challenge is to ensure that all procedures are done according to the study protocol. At times, patient visits may fall on late nights or on weekends. Investigators and study coordinators stayed back to complete the procedures, nasal swab and PK samples were sent to the central lab, and all data points in electronic data capture system was recorded clearly in the source document. In the end, both sites managed to randomize 4 subjects and screened a total of 12 subjects.
I am very lucky to have these 2 sites as my study site. With the teams effort, the trial ran smoothly. Database lock was also achieved a day earlier compared to planned date and there were no major protocol deviations. After the completion of this trial, both sites received another similar trial. I believe principal investigators play an important role in encouraging participation of other doctors in a clinical trial. The intangible benefits of being involved in a trial is priceless. It is an experience that cannot be obtained through routine clinical care. It gives doctors an opportunity to contribute to the development of new drugs and treatment, besides being exposed to international standards of good clinical practice. It was also a joy to know that the Sub-Investigator of this trial was selected to be the Principal Investigator for a new trial. By having more and more experienced investigators, Malaysia can be one step closer to be the hub for clinical research in this region.
I would like to take this opportunity to thank the teams involved in this trial. Their hard work, commitment and willingness to take up the challenge ensured the successful completion of this trial.