The largest company recruiting clinical subjects

Drug Clinical Trial Network. Provide patient subject recruitment, healthy volunteer recruitment, and healthy subjects for clinical trials, build a communication platform for patients, doctors, and new drug researchers, popularize clinical trial knowledge, and safeguard the rights and interests of subjects. The subject recruitment website is based on the largest professional clinical trial website in China - Drug Clinical Trial Network. How to recruit subjects?

Generally used recruitment methods are:

1. The researcher discovers the source of the disease during the treatment and talks about the informed information;

2. The doctor discovers the disease during the treatment The source of the disease, and recommend project researchers to discuss the matter;

3. Recommendations from doctors from other hospitals or community hospitals;

4. Place recruitment advertisements in the hospital (website);

5. Printing and distributing materials, such as patient education related;

6. Publicity through advertising, television and other media;

7. Publicity through new media, such as WeChat, QQ, forums, and websites;

8. Patient database screening and contact intention;

9. Subjects recommend patients or friends around them;

10. In-hospital recommendations, pay attention to whether Vulnerable groups.

As the project leader, you must be foreseeable about the recruitment situation, assess possible subject recruitment problems in advance, and take recruitment measures in advance to reduce possible risks. As long as positive measures are taken, such as relevant reward policies and sponsors' coordinated visits to the center, the recruitment situation will have a positive response.

Protocol design

The inclusion criteria are too ideal and out of touch with the actual clinical situation. The number of subjects is small; the trial operation process is complex, and the number/amount of subject specimen collection or interviews are If the number of viewings is too many, the subjects will be unwilling to participate; if the subjects benefit less, it will be unattractive to the subjects.

Researcher

The researcher has heavy clinical tasks and does not have the energy to recruit subjects for clinical trials;

The informed consent communication is not thorough, and the subjects are not Lack of detailed understanding of clinical trials;

The researchers who negotiated informed consent have low qualifications and have not gained the trust of the subjects.

The subjects

are resistant to clinical trials and refuse to be "guinea pigs";

are unwilling to come to the center frequently for laboratory examinations and follow-up visits, Or they are out-of-town subjects who cannot be followed up on time;

The subjects have a good financial foundation and do not care about the benefits of clinical trials.

In addition to the above common reasons, there is another situation that is often ignored, that is, the feasibility survey is not accurate enough. This influencing factor is often easily overlooked, but it has a great impact on the progress of subject recruitment; this is also a factor that the project manager can manage and control. According to the feasibility study of a large-scale medical school that Tailan Medical trainer was responsible for in the past, 24 centers could complete the enrollment of subjects within 6 months, but the actual enrollment time was nearly 10 months.

Therefore, in the early stage of center selection and feasibility investigation, it is necessary to discuss the specific conditions of subject enrollment with the researchers in detail, in order to obtain as accurate information as possible and facilitate the formulation of recruitment plans:

Trial protocol, drugs and indications, inclusion and exclusion criteria, trial operation procedures

Estimated recruitment and screening, number of enrolled subjects

Estimated completion of screening, enrollment Time of the group

Specific sources of subjects

Specific recruitment methods

Whether there are competitive trials

When formulating the recruitment plan, for The feasibility survey data should be used as a reference after processing. However, if you only rely on the survey data blindly, it will easily lead to the recruitment plan being inconsistent with the actual situation, causing trouble to project management.

As the project leader, you must be foreseeable about the project enrollment situation during the trial, assess possible subject recruitment problems in advance, and take recruitment measures in advance to reduce possible risks. Although the school mentioned above has encountered recruitment difficulties many times, it has been taking proactive measures so that the final recruitment was basically completed as planned. As can be seen from the figure below, enrollment is easily affected by issues such as holidays and the fatigue of research centers in the later stages of enrollment. However, as long as positive measures are taken, such as relevant reward policies, sponsors’ coordinated visits to the center, etc., the recruitment situation will improve Positive reaction.

In this study, a large number of incentive measures were adopted for the recruitment of subjects, and many recruitment channels for subjects were tried. From these recruitment channels, it can be seen that the researchers still is the most important role, among the 1127 subjects screened, 729 were recruited by the researchers. Therefore, during the recruitment process, the training and supervision of researchers are most important. At the same time, they can assist with other effective recruitment measures, such as recommendations from physical examination centers or related departments, internal recommendations from subjects, etc. These measures also effectively ensure that subjects are Of course, the specific measures will depend on the project situation.

In short, in the subject recruitment process, it is very important from the formulation of the early recruitment plan to the implementation of specific recruitment measures, and the project leader must have a good grasp of the overall progress of the project and make strategic plans. , so that subject recruitment management can be easily achieved. The difference between invitation-only participation and recruitment of subjects

is the difference between group-oriented and welfare-oriented.

Participation is by invitation only, you can only go by invitation, it is not recruiting from the general public, and there are no compensation measures. The ethical review of subject recruitment mainly includes recruitment methods, selection of subject groups and incentive and compensation measures. Recruitment methods must consider the principles of respecting privacy and voluntary participation, and avoid coercion and undue influence.