Facilitating Patient Enrollment in Clinical Trials. By Pankaja Kulabkar

Transcription

1 Facilitating Patient Enrollment in Clinical Trials By Pankaja Kulabkar

2 About Me 2 7+ as Technical Writer (Persistent Systems) Research & grant-making PhD (U.K.) Fellowships & published in international journals

3 Clinical Trials Definition 3 Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans.

4 About Clinical Trials in India - 1 Optimism RNCOS, November

5 About Clinical Trials in India - 2 Anxiety and concern Outlook Business, March

6 What Has Gone Wrong? Some facts and analysis 6 Outlook Business, March 2014

7 Agenda 7 Identify the modes of communication Understand the clinical trial guidelines Engage with patients to understand expectations

8 Identify the Modes of Communication 8 Reads newspaper Listens to radio Visits doctor Browses internet Watches television Advertisement Advertisement Brochure Video Website Advertisement

9 Radio Advertisement 9 www. dreamstime.com

10 Poster 10 Diagnosed with Diabetes Type 1? Volunteer in our clinical trial. Dr. Shweta:

11 Brochure 11 About our clinical trial Diagnosed with Diabetes Type 1? Why participate? Join our clinical trial. Call Dr. Shweta: Your feedback matters

12 Video 12

13 Website 13

14 Television Advertisement 14 www. medindia.net

15 Understand the Clinical Trial Guidelines Guidelines: Do s 15 Clarify that a trial involves research Include eligibility criteria and duration State that the ad has been approved by an EC Provide contact name and phone number Reviewing Clinical Trials: A Guide for the Ethics Committee Editors Johan PE Karlberg and Marjorie A Speers

16 Understand the Clinical Trial Guidelines Guidelines: Don ts 16 Words New medicine or promising medicine Implied or expressed claims of safety or efficacy Promotion for the medicine Mention the compound s name Undue emphasis on reimbursement

17 Sample 1 17 DO YOU HAVE INFLUENZA? If your answer is YES you may be considered an eligible participant for entry into a clinical trial of a promising new drug for the treatment of influenza. By participating in the trial, you will receive the following benefits: Free medication Free medical examinations by a qualified physician Reimbursement of travel costs to and from the hospital For further information contact: Dr. Kim - telephone

18 Sample 1 18 DO YOU HAVE INFLUENZA? If your answer is YES you may be considered an eligible participant for entry into a clinical trial of a promising new drug for the treatment of influenza. By participating in the trial, you will receive the following benefits: Free medication Free medical examinations by a qualified physician Reimbursement of travel costs to and from the hospital For further information contact: Dr. Kim - telephone

19 Sample 2 19 DO YOU HAVE CHRONIC HEPATITIS? If your answer is YES and you are 18 years or over, you may be considered for entry into a clinical trial. The clinical trial will last for 18 months. The drug is for treating chronic hepatitis B. By participating in the trial, you will receive the following benefit: Free medical examinations and reimbursement of travel costs. For further information, contact Dr. Shweta, The General Hospital, Bangalore. Telephone:

20 Sample 2 20 DO YOU HAVE CHRONIC HEPATITIS? If your answer is YES and you are 18 years or over, you may be considered for entry into a clinical trial. Explain The clinical trial will last for 18 months. The drug is for treating chronic hepatitis B. By participating in the trial, you will receive the following benefit: Free medical examinations and reimbursement of travel costs. Contribute For further information, contact Dr. Shweta, The General Hospital, Bangalore. Telephone:

21 Engage with Patients to Understand Expectations 21 Clinical Trials: The importance of viewpoint. Whitney Quesenbery I had actually contacted one person. It was very interesting speaking to him on the phone because even as he was talking to me, the patient, he was saying, Well, you know, statistics we ve had, (he was really excited) One person it worked completely but she still died. But then we had one other person who had partial remission and then some surgery and she s been living for four years and that is great for adrenal cancer. He s talking about this all excited as a researcher and I m going, I m sorry, I m about to start breathing into a paper bag. I realize this is exciting research for you but I m the patient on the phone.

22 Engage with Patients to Understand Expectations 22 Take their feedback

23 Acknowledgements 23 Persistent Systems & partners

24 References 24 Batova, Tatiana (2010) Writing for the Participants of International Clinical Trials: Law, Ethics, and Culture, Technical Communication

25 Thank You!!!