Health camps for recruiting patients in clinical trials :Health camps for recruiting patients in clinical trials By, Sudakshina Kashyap Kamini Kaushal Priyanka Pramanick Guided By: Dr. Satish Satish Dara


Background :Background Trials need sufficient patients to ensure statistical power and validity, but recruitment remains problematic. The goal of recruitment camps is to be “glocal” – To think globally and act locally. The clinical relations team develops and maintain relations with a cohort of GPs and consultants in the local area who would refer trial specific patients.


Need for health camps :Need for health camps Due to prevailing poor recruitment and poor retention Awareness Serves the poor and unprivileged population.(rural) Helps to minimize the burden at the site by referring only pre-screened patients. Large patient pool with different diseases and background can be recruited. Motivates naïve and uneducated participants Provides opportunities to receive better standards of treatment/healthcare


For the topic :For the topic Models the flow of patients through health camps -Active patient participation To accelerate recruitment Promotional activities /programme Benefit to people - Free diagnosis and treatment Helpful for patients who cannot afford to consult physicians due to economic constraints in India.


Slide 5:Selection of patients for clinical trial for a particular indication satisfying their eligibility criteria is much easier. Saves enrollment time Better patient retention by providing professional care & supporting environment to patients. Less need for repeated monitoring visits, thus savings in time and cost.


Slide 6:Maximizing site performance. Access to patients Improve patient’s awareness perception & education. Ease of business. Cost effective patient recruitment. Increase number of quality patients per site Faster patient recruitment and timely completion of studies.


Against the topic :Against the topic Use of coercive and misleading advertising techniques in the health camps-Distrust of advertising. Payments to subject for participation may compromise the integrity of the recruitment process. Financial incentives given to subjects to help recruitment efforts when there is no/minimum health benefit. Most of the times it is not considered for benefit, but recruitment initiatives. May violate professional ethics codes and federal regulations.


Slide 8:The practice of advertising that a investigational product is effective or safe, without the completion of appropriate studies violates the FDA regulations. [21 CFR 312.7 and 21 CFR 812.7]. The incentives given to the subject should only be enough to balance costs of Transportation, food and Time Compensation provided in most cases exceeds the costs incurred by the participant and compels the subject to take part in the trial. The IRB scrutinizes this aspect of recruitment to be sure that compensation provided does not cause an undue influence on the subjects trial-related decisions.


Slide 9:Advertising campaigns by Health Camps especially in the rural areas compel patients to join the trial by designing deceitful tactics. Use of words such as ‘New drug’ or ‘New Treatment’ creates a wrong opinion in the minds of the participants. Compensation given to participants also should not be mentioned in such campaigns as many people tend to take part in a trial just to receive monetary benefits. This may also reduce standards of the Informed Consent process.


Conclusion :Conclusion We stand for the topic keeping in mind: Motive should be transparent. Should involve trained investigators and CRC s and staffs for recruitment. Sponsors and health camps must balance their enthusiasm for the research with the need to maintain an atmosphere that minimizes the possibility of coercion or undue influence. To recruit participants health camp requires both selective screening and good relationship with the subjects and sponsor.(Strong doctor/patient trust relationship)


THANK YOU……………… :THANK YOU………………