Clinical trials involve subjects as well as patients. Recruitment and retention of patients are central to the exercise. Great care has to be exercised at every stage of patient induction. Availability of large patient population for enrolment in a proposed Clinical Trial is a Myth. Most of these patients vanish as the trial begins. Internationally, recruitment and retention of clinical trial patients are a big challenge. More than 80% of global trials fail to enroll on time, with 52% delayed by 1‐6 month .Failure to recruit patients on time leads to loss of over 85‐95% of days in a clinical trial. India has become an attractive country due to its potential for rapid recruitment of patients. Many optimistic estimates suggest that patient enrolment rates in India could be 3‐4 times faster than Western countries. However, the number of patients who complete the trial decides the success of a global trial.
More and more drugs on trial have been designed to attack very specific biological targets. This necessitates the need to identify, recruit and retain patients that fit an increasingly narrower medical profile. Therefore, pharmaceutical companies and clinical research organizations (CRO) are seeking new ways to optimize recruiting operations and gain a competitive edge. Operational delays in clinical trials reduce patent exclusivity time and shorten the most commercially productive phase of a product’s life cycle. This results in financial loss and missed market opportunities for potential blockbusters. The primary source of such delays is the recruitment and retention of patients that fit the trials ‘requirements.

Slow patient enrollment…reasons
1) Too rigid inclusion/exclusion criteria.
2) Poor motivation for Clinical Trial site personnel
3) Clinical Trial monitors not proactive
4) Competition for enrollment (financial Incentive greater from other sponsor)
5) Unrealistic enrollment expectations
6) Inaction against site specific reports by Clinical Trial Monitors

Recruitment tactics…..
1) Increase the accessible pt. population (increase time frame and CT sites)
2) Relax inclusion/exclusion criteria (progressively from phase 2 to phase 4, not to disturb pre‐set randomization)
3) Wider publicity (advertisement, internet). The Internet is an important tool to recruit both patients and physicians, but remains under‐utilized.
4) Clinical Trial sites and/or Clinical Investigators pressurized to increase patient enrollment, also inducing own patients to enroll.
5) Payments to other Investigators for enrolling their patients (Referrals)
6) Financial inducement to exceed targets
7) Penalties for sites not meeting targets.

Retention of enrolled patients/subjects…
1) Make patient partner in treatment
2) Explain to him/her the commitment to CT
3) Provide good quality professional care(minimize waiting period, listen patiently to complaints about treatment or ADRs, explain all queries regarding CTs)
4) Explain dosage schedule in detail and consequences of non‐adherence to schedule
5) Explain likely ADRs, and action if occurs
6) Financial package for enrollment in Clinical Trials
7) Incentive for completing Clinical Trial

In Non therapeutic trials, adequacy of Financial Package determines the size of your “Volunteer Bank”. In therapeutic trials, undisclosed personal financial incentives to Clinical Investigators are often used to increase patient recruitment rate or to exceed the target. For increasing recruitment, patient participation has to be increased. Protection of rights, well being and Confidentiality of patients has to be increased. All concerns of the patients for lack of efficacy or ADRs should be carefully attended to and assessed. It has to be remembered that “a satisfied patient is the best ambassador for patient enrolment in future C.T.’s by persuading the fence sitters “