Clinical research is a process that studies a new treatment effectiveness. While it is a very good opportunity for doctors to study the disease development and treatment, the conduct of clinical research by doctors themselves requires a huge budget. Industry Sponsored Research (ISR) provides a good opportunity for doctors to be involved in new and ground-breaking research that may potentially change the course of treatment globally. The number of clinical research has been increasing over the past 10 years. Almost 50% of all trials registered in clinicaltrial.gov showed that it is conducted in Asia. However, less than 1% of the registered clinical research came to Malaysia. To increase the number of ISR in Malaysia, feasibility process plays an important role.
Feasibility is a process where the pharmaceutical company sends requests for information to analyse which country is a suitable site to conduct a specific trial. With the information, project managers will need to come up with a strategy to ensure that the trial can be completed within the allocated timeline. Information given by the site is very important as it will affect the decision outcome. Below are a few general information that a sponsor usually requests before they decide to carry out a trial in the country:
Patient population for a specific disease
This is the most important factor that is taken into consideration when deciding if a trial should be conducted in a country. A high number of patient population will always be an advantage to the country to be selected but a low number of patient population does not mean the country will not be selected. For some trial, sponsors may need to gather subjects from a few regions that covers several countries. It is important for each site to provide to the sponsors the best estimation in the number of patients that can be recruited. If a country is consistent in providing the committed number of patients, sponsors will be willing to conduct more trials in that country. It is the role of the investigators to provide an accurate estimation of the number of subjects that he/she sees in a week/month, and of this, how many may be recruited.
Investigators must also consider the availability of the site’s resources such as manpower and facility as well as holidays/festival which will affect the recruitment process. It is also encouraged for investigators to share their recruitment strategies. With a reasonable number of subject commitment and a good recruitment strategy, sponsors may consider bringing in the trial into the country.
Standard of care for a specific disease
Once a sponsor has information on the patient population, the next thing that they will enquire is the standard of care practiced in the country. A protocol design should not deviate much from the local standard of care as this may affect the study result data or may cause ethical issues. At the very least, the comparator arm drug should be registered in the country for the same indication. Sometimes, sponsors may also invite the investigator to develop and contribute in the protocol design. Sponsors will usually choose a country where the investigator is interested in the protocol design and have the same direction in achieving the protocol objective.
Sponsors will need to know the type of facility available at the site and this may include laboratory service, radiology department service, sample tissue processing machine, courier services, manpower (eg. sub-investigators and study coordinators), investigational product storage place or equipment in the ward. The facility requirements at the site differ according to the different protocols. Thus, the investigator and sponsor must discuss in detail during the feasibility process. Although most of the services can be outsource to a nearby center, the site will need to share with the sponsor their standard operating procedures in outsourcing the procedure to the other center. Besides the availability of facility, manpower resource is also very important. An investigator should always have a team who is experienced in conducting clinical research. The principal investigator and sub-investigator must be familiar with documenting medical notes after reviewing a subject. Study coordinators also play an important role in making sure that the study is conduct as per protocol. At the end of the day, an experienced clinical trial site may influence a sponsor’s decision in choosing that particular site.
Short Startup Timeline
The startup timeline always depends on health authority and ethic committee submission timeline. After a site receives the study document, its investigator must review the document before submitting to the ethics committee. The investigator may be required to attend a meeting held by the ethics committee to defend/present the protocol and explain the objectives of the trial. Both investigator and sponsor must work very closely to provide a good timeline estimation whereby the investigator can commit to the submission process. Both parties should also share their schedule plans on the study to ensure that it will not cause any delays.
Having a competitive trial is not a disadvantage because it goes to show that a site has the ability to conduct a similar trial. The risk taken by the sponsor will be that the site may not comply to the protocol design or may not commit to the recruitment target. However, if the site is able to share their recruitment strategies, the sponsor will be happy to work with them.
By 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.